Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Breast Neoplasms

Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

Intervention of arm compression only by Flexitouch System

Intervention of arm, trunk and chest compression by Flexitouch System

( 10 to 30 treatments depending on group assignment)

Flexitouch System

Sheila H Ridner, Phd

No studies have tested the potential benefit of the Flexitouch® truncal/chest garments on reducing truncal lymphedema in breast cancer survivors (BCS) or the theoretical added benefit of applying truncal/chest pneumatic compression therapy to open lymph channels in individuals who have only limb lymphedema or its impact on the trunk/chest. The purpose of this two-part study is to fill gaps related to: 1) the impact of the Flexitouch® System on truncal lymphedema, and 2) the therapeutic benefit of truncal /chest pneumatic compression therapy for arm lymphedema.

Hypotheses:

Part One: BCS with arm and truncal lymphedema. H1: Arm swelling (as measured by bioelectrical impedance \& arm girth in cm) will be reduced after 10 sessions with the Flexitouch® System.

H2: Truncal swelling (as measured circumferentially) will be reduced after 10 sessions with the Flexitouch® System.

H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by the Lymphedema Symptom Intensity and Distress Scale: Trunk and Arm) will be reduced after 10 sessions with the Flexitouch® System.

H4: Functional assessment scores (as measured by the Functional Assessment Screening Questionnaire \[FASQ\] will improve after 10 sessions with the Flexitouch® System.

Part Two: BCS with Arm Lymphedema H1: Arm volume (as measured by bioelectrical impedance \& arm girth in cm) will be significantly reduced after one month of home use in participants using the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only).

H2: Truncal measurements/volume (as measured circumferentially) will be less after one month of home use with the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only).

H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by Lymphedema Symptom Intensity and Distress Scale - Arm ) will be significantly reduced after one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when compared to individuals using the Flexitouch® System (arm compression only) .

H4: Functional assessment scores (as measured by the FASQ) will be significantly higher after one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when compared to individuals using the Flexitouch® System (arm compression only).

Screening Procedures This study will have a three-phase screening process.

Phase One:

Participants will be screened either in person or via the telephone.

Phase Two:

If the person being interviewed is eligible and interested, study staff will obtain phone consent for a brief interview to obtain basic medical and treatment information and to share this information with the study doctor, who will write prescriptions for treatment based upon these data. After a prescription is obtained, study staff will contact participants by phone and schedule the on-site visit.

Phase Three:

Participants will come to the Vanderbilt University for measurement of arms and truncal assessment. Phase Three Screening informed consent will be obtained prior to any measurements. These measurements will serve as baseline entry into the study for those who meet criteria.

Baseline Interview All Participants: Once written informed consent is obtained, study staff will interview the participants to obtain demographic and treatment (lymphedema and breast cancer) history. Participants will complete symptom and quality of life forms.

Part One Study:

Dosage and Setting:

Participants will receive a total of 10 treatments, one hour per day for 10 days consecutively. Treatment One will be conducted under study staff supervision at VUSN or other Vanderbilt location. Treatments Two through Ten will be self-administered, at home, as this is an FDA approved at-home self-care device.

Study staff will make an at home visit for Treatment Two in order to observe the application and use of the device and to measure the participant's trunk and arms and examine arm and trunk.

Home Treatment One Observation and Measurement:

Physical Assessment/Measurement:

* Study staff will visually examine the affected and unaffected arms and truncal areas (collarbone to navel and small of back).
* Participants will be asked to sit at their dining table with arms extended to the side at shoulder height at shoulder level. A non-flexible tape will be used to measure girth at the metacarpal shaft of the hand and then, starting at the ulnar styloid, in 10 cm intervals to the shoulder. Each arm will be measured 2 times and the average used.
* Study staff will then measure the trunk twice at five locations.
* During bioimpedance: Study staff will assist the patient onto a bed or sofa and measure arm volume using bioelectrical impedance. Participants will be placed in a supine position with legs not touching one another. An alcohol pad will be used to prep each wrist next to the joint, the dorsal surface of each hand (1 cm proximal to the middle knuckle), and the dorsal surface of one foot (1 cm proximal to the joint of the second toe). These areas will be allowed to dry and lightly adhesive electrodes will be applied. Measurement of affected and unaffected arms will be conducted as directed by the computer software in each impedance device. This measurement will take less than five minutes. The leads and electrodes will then be removed.
* Study staff will weigh the participant twice and record the average.
* At the end of the treatment session, study staff will again measure the arms and trunk of the participant. Using the same procedures.

Treatment Observation:

Staff will observe for:

* Participants going to restroom, removing any compression garments, constrictive clothing/undergarments or foot coverings they are wearing, and to removing any jewelry prior to treatment.
* Participants changing into scrub suits.
* Use of treatment record checklist to set dials
* Participants resting in a supine position during treatment.
* Appropriate placement of garments.
* Pressures will be set at manufacturers recommended levels of compression using program UEO1/U1 and standard pressure (not intense pressure) only.
* Active time on the device approximately 60 minutes.
* Completion of treatment record checklist after treatment.
* Staff will correct any errors noted and educate as needed.

Measurement Visits (Between Treatment 5 and 6 (+ or - 1 treatment), and within 72 hrs after Treatment 10, Exit from Study):

Data Collection:

Physical Assessment/Measurement:

* Study staff will visually examine the affected and unaffected arms and truncal areas (collarbone to navel and small of back) and document findings on the Skin Checklist.
* Participants will be asked to sit at their dining table with arms extended to the side at shoulder height at shoulder level. A non-flexible tape will be used to measure girth at the metacarpal shaft of the hand and then, starting at the ulnar styloid, in 10 cm intervals to the shoulder. Each arm will be measured 2 times and the average used.
* Study staff will then measure the trunk at the five locations. During bioimpedance: Study staff will assist the patient to lay flat on a bed or sofa and staff will measure arm volume using bioelectrical impedance. Participants will be placed in a supine position with legs not touching one another. An alcohol pad will be used to prep each wrist next to the joint, the dorsal surface of each hand (1 cm proximal to the middle knuckle), and the dorsal surface of one foot (1 cm proximal to the joint of the second toe). These areas will be allowed to dry and lightly adhesive electrodes will be applied. Measurement of affected and unaffected arms will be conducted as directed by the computer software in each impedance device. This measurement will take less than five minutes. The leads and electrodes will then be removed .
* Study staff will weigh the participant twice and record the average.

Interview:

• Participants will complete the symptom and quality of life forms.

Part Two (Experimental and Control Groups)

Dosage and Setting:

Participants will receive a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One will be provided under study staff supervision . Treatments Two through Thirty will be self-administered, at home, as this is an FDA approved at-home self-care device.

Data Collection Initial On-Site Visit:

Physical Assessment/Measurement:

* Participants will be asked to void (for comfort during procedure), to remove any compression garments, constrictive clothing/undergarments, or foot coverings they are wearing, and to remove any jewelry.
* Participants will be asked to change into scrub suits.
* Participants will have their height (using a portable stadiometer) and weight (using a Pro-fit Electronic Scales) measured twice and the average will be recorded .

Treatment:

* Study staff will review the procedure in the manual for self-administration of the device and ask for participants to demonstrate their ability to apply the device and use the appropriate settings. Participants will view a video about the device.
* Participants will apply the Flexitouch® System garments (actual garment to be placed will be determined by randomization to experimental or control group) over and scrubs in the arm and trunk areas.
* Participants will rest supine on the massage table with their head on a pillow, if necessary, during treatment.
* For subjects randomized to the Experimental Group: Pressures will be set at manufacturers recommended levels of compression using the standard upper extremity program (UEO1/U1) and standard pressure (not intense pressure) only. Active time on the device will be approximately 60 minutes.
* For subjects randomized to the Control Group: pressures will be set at manufacturers recommended levels of compression using program for arm compression only (UE04/U4), chest will not receive compression, and standard (not intense pressure) only. Active treatment time for Group B patients will be approximately 40 minutes.
* Study staff will remain present during the treatment. Should a participant experience discomfort or request to stop the treatment, study staff will immediately turn off the device and remove the garments.
* At the end of the treatment session study staff will measure the arms and trunk.
* Trunk will be measured twice using a non-flexible tape.
* Bioelectrical Impedance: Study staff will assist the patient onto a non-metal massage table covered with clean linen and staff will measure arm volume using bioelectrical impedance. Participants will be placed in a supine position with legs not touching one another. An alcohol pad will be used to prep each wrist next to the joint, the dorsal surface of each hand (1 cm proximal to the middle knuckle), and the dorsal surface of one foot (1 cm proximal to the joint of the second toe). These areas will be allowed to dry and lightly adhesive electrodes will be applied. Measurement of affected and unaffected arms will be conducted as directed by the computer software in each impedance device. The leads and electrodes will then be removed and cleaned with an alcohol pad.
* Circumferential: With arms extended to the side and at shoulder level, a non-flexible tape will be used to measure girth at the metacarpal shaft of the hand and then, starting at the ulnar styloid, in 10 cm intervals to the shoulder.

Measurement Visits (After Treatment 14 (+or- 2 treatments) and within 72 hours after Treatment 30 (Exit from Study) :

Data Collection:

If the participant opts to come to Vanderbilt the measurement procedures for arms and weight will be the same as in the first onsite. If the visit takes place at-home the following procedures a will be used:

Physical Assessment/Measurement:

* Study staff will visually examine the affected and unaffected arms and truncal areas (collarbone to navel and small of back) and document findings on the Skin Checklist (Attachment C form 12).
* Participants will be asked to sit at their dining table with arms extended to the side at shoulder height. A non-flexible tape will be used to measure girth at the metacarpal shaft of the hand and then, starting at the ulnar styloid, in 10 cm intervals to the shoulder. Each arm will be measured 2 times and the average used.
* Study staff will then measure the trunk at the five locations noted on Attachment C form 11. Study staff will assist the patient onto a non-metal massage table covered with clean linen and staff will measure arm volume using bioelectrical.
* During bioimpedance: Study staff will ask the patient to lay flat on a bed or sofa and staff will measure arm volume using bioelectrical impedance. Participants will be placed in a supine position with legs not touching one another. An alcohol pad will be used to prep each wrist next to the joint, the dorsal surface of each hand (1 cm proximal to the middle knuckle), and the dorsal surface of one foot (1 cm proximal to the joint of the second toe). These areas will be allowed to dry and lightly adhesive electrodes will be applied. Measurement of affected and unaffected arms will be conducted as directed by the computer software in each impedance device. This measurement will take less than five minutes. The leads and electrodes will then be removed .
* Participants will be weighed twice and the average recorded.

Interview:

• Participants will complete the symptom and quality of life forms.

Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer

measured by tape and then volume was calculated.

Lymphedema Symptom and Intensity Scale-Arm measures 30 symptoms yes no over the past 7 days . Total yes items added for number of symptoms.

Tactile Systems Technology, Inc.

Vanderbilt University

Associate Professor

Arm Compression Only

Arm, Trunck and Chest Compression

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

sheila h ridner

Arm Volume at End of Study

Baseline

End of Treatment

Compression in arm, trunk and chest compression

Arm, Trunk and Chest Compression

Symptom Improvement

Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.

Overall Study

Nervous System Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Participants will receive cryotherapy on both hands and feet

Cryotherapy

Participants will receive compression on both hands and feet

Compression

Amelia Scott

Mary K Anastasio

Laura Havrilesky, MD

Laura Havrilesky

The investigators aim to determine the effect of cryotherapy wraps plus compression therapy (henceforth referred to as cryocompression) versus cryotherapy wraps alone on the incidence and degree of chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer using a noninferiority design. The investigators also aim to determine the effect of cryocompression versus cryotherapy on patient tolerability and patient and staff satisfaction.

Participants will be randomized by patient to receive cryotherapy wraps plus compression therapy (cryocompression) versus cryotherapy wraps alone applied to the bilateral hands and feet. Participants will receive cryotherapy (+/- compression) for the duration of their taxane infusions. Participants will be asked to complete the FACT-NTX survey and a PNQ neuropathy surveys at each infusion visit to evaluate symptoms related to neuropathy. Participants will also complete a brief acceptability and tolerability survey at each visit. Lastly, a staff satisfaction survey will be administered at each visit as well. The investigators will test the hypothesis that the average final visit FACT-NTX11 scores in the cryotherapy group are noninferior to the cryocompression group with a noninferiority margin of 2.5 points. The investigators will routinely monitor for the following adverse events: frost bite, (unexpected) hospitalizations, and death.

Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2

Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer: a Randomized Controlled Trial - COHORT 2

The FACT-NTX is a patient self-reported 11-item questionnaire used for evaluating symptoms and concerns specifically associated with chemotherapy induced neuropathy. The total score ranges from 0-44, and a lower FACT-NTX score corresponds to worsening neuropathy. For both the FACT-NTX and the sensory subscale of the FACT-NTX, a significant decrease in the score is defined as a decrease exceeding 10% from baseline.

Subjects will be asked to complete a cryocompression tolerability assessment after each chemotherapy session in which they will answer the question, "How tolerable was the cryocompression procedure for you?" on a scale from 0 to 100. A score of 0 means "not tolerable at all" and a score of 100 is "very tolerable". Pain, abnormal sensation, and adherence to cryocompression will also be evaluated as patient-reported measures of tolerability.

Subjects will be asked to complete a cryocompression acceptability assessment after each chemotherapy session in which they answer the questions, "How acceptable was the cryocompression procedure to you?" and "How likely are you to continue with cryocompression at your next chemotherapy treatment?" on a scale from 0 to 100, with 0 being "not acceptable, not likely to continue" and 100 being "very acceptable, very likely to continue".

Staff will be asked to complete an acceptability assessment after each chemotherapy session in which they will answer the question, "How manageable or acceptable was this patient's cryotherapy/cryocompression therapy to you in working with a patient receiving chemotherapy?" on a scale from 0 to 100. A score of 0 means "not at all acceptable" and a score of 100 is "complete acceptable". They will also be asked "In your experience, compare the ease of use of the cryotherapy wrap versus plastic ice bags" on a scale from 0 to 100. A score of 0 means "cryotherapy wraps are much harder," and a score of 100 means "cryotherapy wraps are much easier."

PNQ is a patient-reported questionnaire that consists of 2 items, representing motor and sensory components, with increasing grades for worsening symptoms. Patients will respond to each question for each of their 4 extremities by grading sensory and motor symptoms as A (no neuropathy), B (mild neuropathy), C (moderate neuropathy that does not interfere with activities of daily living \[ADL\]), D (moderate neuropathy that does interfere with ADL), or E (severe neuropathy that interferes with ADL).

Study staff will record the taxol dose at each cycle

Duke University

Symptoms and General Pathology

Polyps

Herbal and Botanical

All Drugs and Chemicals

Cola

The Compression anastomotic ring-locking procedure (CARP) device is based on a set of rings to make a compression anastomosis between the intestinal ends.

Compression anastomotic ring-locking procedure (CARP)

The intestinal ends must be rejoined after colonic resection. Conventional methods include sutured and stapled anastomoses, which is associated with 3-6% leakage after colonic surgery. The leakage of an anastomosis can cause serious consequences, such as abdominal infections and/or sepsis. Early detection of anastomotic leakage is the best way to avoid serious abdominal infections. The methods that are used today to detect leaks are unfortunately not very accurate. These methods include monitoring symptoms, temperature, and CRP-levels, and performing abdominal examinations and tomography scans. Because of the difficulties in objectively assessing these parameters, the anastomotic leaks are often diagnosed late. When reoperation is required, a permanent stoma may be made at the level of the sigmoid colon. The CARP system has been developed to achieve a safe anastomosis. The CARP is designed to providing an improved contact surface between the two intestinal ends and the ability to precisely investigate the anastomosis during and after surgery using the catheters of the CARP system. Standardized use of the CARP to anastomose the large intestine may provide significant advantages in the field of colorectal surgery.

Compression Anastomosis Using the Compression Anastomotic Ring-locking Procedure (CARP)

Safety Study of Compression Anastomotic Ring-locking Procedure (CARP) in Patients Undergoing Colonic Resection

Carponovum AB

Region Skane

Breast Cancer Lymphedema

Postoperative Complications

* Receive information: the patient receive a leaflet with information about the lymphatic system and lymphedema, clinical evaluation and conservative treatment of lymphedema
* Perform skin care
* Perform twice a day upper limb exercises at home. They are advised to use the arm as normal as possible.

* Receive information: the patient receive a leaflet with information about the lymphatic system and lymphedema, clinical evaluation and conservative treatment of lymphedema
* Perform skin care
* Perform upper limb exercises at home twice a day. They are advised to use the arm as normal as possible
* Wear a compression sleeve

a compression stocking is worn, a garment compression class 2, flat knitted

compression

Sarah Thomis, MD

wendy leus

wendy Leus

Breast-cancer related lymphoedema (BCRL) is a common phenomenon. Early diagnosis and treatment is very important to alter the normal progression of this disease. A threshold (\>= 3% volume change) that recognizes subclinical lymphedema is promoted. When the lymphedema is diagnosed late, options for treatment are diminished as fibrous tissue is formed.

Preoperative investigation with near-infrared fluorescence lymphography can show an abnormality. Even if a linear transport is visualized, velocity of the transport can be diminished or a different pathway than normal can be visualized. Such an extensive evaluation has not been performed yet.

This lymphofluoroscopy gives an opportunity to detect lymphedema earlier than clinically visible (subclinical). The investigators hypothesize that the evolution of lymphedema can be altered if treatment is started in the subclinical phase.

Breast-cancer related lymphoedema (BCRL) is a common phenomenon. Estimates of incidence rates have varied over time, especially since the progression to less invasive techniques as sentinel node procedures and radiotherapy. According to a review article of DiSipio the incidence of arm lymphedema was about four times higher in women who had an axillary lymph node dissection (18 studies; 19.9%, 13.5-28.2) than in those who had sentinel lymph node biopsy (18 studies; 5.6%, 6.1-7.9). Several other risk factors are already suggested as having a negative impact on the development of lymphedema such as BMI and chemotherapy. A comprehensive overview of all treatment related risk factors and patient related risk factors, including demographics, has not been reported yet.

Lymphedema is identified with upper limb volume measurements eg circumference measurements, water displacement and perometer. Bioimpedance spectroscopy can also be used to assess the extracellular fluid. A 10% limb volume change has been reported as the most accurate threshold to diagnose lymphedema. However, with this definition an underestimation of the incidence rate of lymphoedema is made. Therefore, recently a threshold of 5% limb volume change is proposed.

A study by Rockson et al suggested that in almost 75 % of the cases, lymphoedema is established in the first year after breast cancer treatment. But up to two years after surgery, there still is a possibility to develop lymphoedema.

Early diagnosis and treatment is very important to alter the normal progression of this disease. A threshold (\>= 3% volume change) that recognizes subclinical lymphedema is promoted.

When the lymphedema is diagnosed late, options for treatment are diminished as fibrous tissue is formed.

During near-infrared fluorescence lymphography (lymphofluoroscopy), a fluorescent substance is injected subcutaneously in the hand and the transport of lymph is visualized from the hand up to the axilla. A normal transport is defined as a linear image and an abnormal transport as a dermal backflow image. The dermal backflow image is divided in three different classifications according to the severity.

Preoperative investigation with near-infrared fluorescence lymphography can show an abnormality. Even if a linear transport is visualized, velocity of the transport can be diminished or a different pathway than normal can be visualized. Such an extensive evaluation has not been performed yet.

This lymphofluoroscopy gives an opportunity to detect lymphedema earlier than clinically visible (subclinical).

The investigators hypothesize that the evolution of lymphedema can be altered if treatment is started in the subclinical phase.

Pre-existing Factors, Early Detection and Early Treatment of Breast Cancer Related Lymphedema

Determining the Role of Pre-existing Factors, Early Diagnostic Options and Early Treatment in the Development of Breast Cancer Related Lymphedema

defined as 5% volume increase compared to the contralateral side

measured by the pitting test at each visit

relative volume difference at assessment - relative volume difference at baseline

scoring dermal backflow in the 13 regions

Universitaire Ziekenhuizen KU Leuven

Vascular Surgeon

experimental bra, compression and stabile

compare two different bra after breast cancer surgery

OptiBra study

Backman

Fredriksson

Malin Backman

This study evaluates how two different types of postoperative bra 1) standard bra, soft VS 2) compression bra compression after breast cancer surgery affect pain, seroma, other symptoms and complications, and the womans experience of comfort

Background

Breast cancer is the most common form of cancer in women and in Sweden about 9700 women are affected each year.Therefore, it is of great importance to promote the rehabilitation process by minimizing unnecessary symptoms and complications that may arise during a breast cancer treatment. Surgery is the primary cure for breast cancer and about 40% need to undergo a major surgical procedur and major operations also involve an increased risk of complications and symptoms.

Pain is the most common reported symptom in women who are operated on for breast cancer other complications after surgery that may occur are seroma, wound infektions and swelling.

No published evidence exists for the benefit and effect in pain relief from wearing a bra as a support after breast surgery is available, therefore it is important to evaluate useful and simple methods that the patient can manage herself that can minimize the experience of pain and other symptom after breast cancer surgery.

At Karolinska University Hospital's breast cancer center, women who undergo breast surgery are offered a bra after surgery in order to provide good support for the patient to feel safe, comfortable and minimize complications and symptoms such as pain. Two different types of bra are used and, according to the clinical staff at Karolinska's breast cancer center clinical experience, there is disagreement about which type of bra gives the optimal effect in different surgical procedures to reduce symptoms and post-operative complications. Neither is there enough knowledge about and how women experience comfort from the bra they received from the healthcare, which is important as the bra should be used large parts of the day for about 3 weeks after the procedure. Lack of knowledge makes it difficult to provide person-centered care for each individual. The purpose of this study is to compare two different types of bra after breast cancer surgery and to evaluate whether a particular type of bra affects the perception of pain, other symptoms, the occurrence of complications and experiences of bra comfort.

Purpose

To compare two different types of postoperative-bra after breast cancer surgery and to evaluate how a particular type of bra affects the perception of pain, other symptoms, the occurrence of complications and comfort.

Outcome Measure

The primary outcome measure is the presence of pain. Secondary outcome measures are, other symptoms, seroma, wound complications, and the patient's experience of satisfaction with support and comfort when using their postoperative bra.

Design

Randomized controlled trial aimed to comparing two groups of women undergoing breast cancer surgery.

Participant

Women diagnosed with breast cancer and undergoing breast surgery.

Data Collection

The data collection will take place at the Breast Center, Karolinska University Hospital in Solna, where approximately 500 breast cancer operations are performed every year. The women will be identified by the nurse or doctor at the MDT conference. The identified women will be asked about the participation of the nurse / doctor at the new visit to the surgeon's reception and bring written information home with them about the study. A few days after the new visit, the woman is called by a researcher or nurse for further oral information and the women who wish to participate will be given written informed consent. After this, baseline measurement and randomization are performed to one of two groups. Evaluation will be performed on two occasions, prior to surgery (baseline for pain and other symptoms, demographic issues) and 3 weeks after surgery (pain, symptoms, clinical assessment of the breast). Demographic (age, education, etc.) and medical information (weight, BMI, illness history, smoking, alcohol habits and physical activity, etc.) as well as the type of surgical procedure and drain are collected through medical records.

Inclusion

Women from 18 years of age with malignant tumor of the breast gland to undergo surgery.

Exclusion

Men with breast cancer. Women with benign tumors or women with health factors where the assessment is that Bra use from healthcare is not necessary or possible.

Compliance and instruments

The participant will be instructed to use the bra according to. Instruction and adherence to intervention will be via diary pages where the participant for 3 weeks briefly fills in (number of days) and how often (number of hours / day) you have used the bra you received from the health care. Primary outcome measure is; pain, secondary outcome measures are, presence of seroma, symptoms after breast surgery mainly swelling, redness, and satisfaction with the use of bra focusing on comfort and support. Instruments for self-estimated outcome measures that will be used are;

* To measure the perception of pain comes the estimation instrument VAS (visual analogue scale). VAS is a 10 cm long horizontal line where on one side measures "no pain" and on the other "worst possible pain" and the patient places a mark on the line corresponding to the perceived pain .
* To measure chest symptoms, EORCT QLQ-BR 23 will be used. BR 23 is a questionnaire that measures common symptoms of breast cancer disease and treatment (eg you have had difficulty lifting or moving your arm, have you had pain around your breast).
* The presence of wound complications, seroma and other symptoms reported by the patient (swelling, redness) will be assessed by clinical assessment of the nurse and medical record. E.g. Seroma will be assessed on the basis of a template based on the number of drops and the amount / ml of dropped liquid.

To examine how participants experience the convenience, comfort, and support of the postoperative bra they used in the study, participants will answer study-specific questions (open and closed) regarding patient experience (patient satisfaction) regarding BRA use that relates to comfort, support and comfort.

Intervention

Participants are randomized into one of two groups. Group 1) is offered the more stable bra with some compression after breast cancer surgery, while Group 2) is offered a softer bra without compression. Participants are encouraged to use the bra according to instructions and record the number of hours / days for use in a diary. When returning to a nurse / doctor after about 3 weeks of use, all participants respond to survey questions about pain, other symptoms and experience of support and comfort during use, and undergo a clinical assessment of the nurse according to a template with respect to seroma, number of taps, quantity and occurrence of complications (eg wound infection). Compliance with intervention takes place trough a simple diary which participants fill in for 3 weeks eg. how long (number of days) and often (number of hours / day) have you used the bra you received from the healthcare system, as well as grading daily pain according to the VAS- scale.

To determine if there are differences between 2 groups with respect to the variable pain as the primary outcome measure, a sample size of 80 women per group is calculated to be necessary with a power of 0.80 percent and a significance level of \<0.05. Given that subgroup analyzes (about 5 groups - mastectomy +- SN, mastectomy +- axillary, sector + - SN, sector +- axillary and primary reconstruction) will be done and a planned 10% drop-out, 100 women per group will be included.

Analysis

Quantitative data will be processed using relevant statistical parametric methods for normally distributed data and non-parametric methods for non-normally distributed data. Analyzes will investigate differences between groups as well as within the group (ANOVA) as well as analyzes for the relationship between different parameters (eg type of bra and surgical procedure). Demographic baseline data is reported as descriptive statistics (SD, mean, frequency). Statistics will be used for support.

Ethical issues

The current research project will follow the basic ethical principles that include the information requirement, the consent requirement, the confidentiality requirement and the use requirement . Involved persons in the team for the BH study all have long experience of meeting people with cancer diagnosis. Close ethical discussion with expertise in the research group on the routines that exist today for bra use after surgery and in randomization so as not to cause or risk injury to the woman. All participants will; receive oral and written information about the study, have the opportunity to ask questions via telephone or mail during the entire study period (the information requirement). Participants will be informed that participation is completely voluntary and that there is no disadvantage if participation is canceled (the consent requirement). Personal data will be de-identified and handled in accordance with statutes to minimize the identity of the participants for unauthorized persons in the reporting of results (the confidentiality requirement).

The collected data will only be used for research purposes (the use requirement).

OptiBra Study, Optimal Postoperative Bra After Breastcancer Surgery

OptiBra Study, Optimal Postoperative Bra After Breastcancer Surgery - an RCT

VAS scale ( Visual analoge scale) , each item is score, 0= no pain to 10= pain as bad as can be. yielding at total between 0 and 10

Clinical observation by doktor 3 weeks after surgery and Medical records

Clinical observation by doktor registrated in Medical journal about number of dropping and ml each dropping. And % of patients suffering from seroma after surgery

EORTC QLQ BR23 questionnaire measure symptoms after breascancer surgery, a 4 item scale, each item i scored from -not at all to verry mutch. We will follow the EORTC QLQ manual for calculation, scale 1-100, where high scores mean more severe symptoms And some study specific questions about experience of Comfort ex.have you experienced that the BRA has given you support

Karolinska University Hospital

Medicine Doctor, Oncologynurse

Wounds and Injuries

Heart and Blood Diseases

Immune System Diseases

Rare Diseases

Fractures, Bone

Multiple Myeloma

Neoplasms, Plasma Cell

Fractures, Compression

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Patients who are asymptomatic (no symptoms) will participate in the observational portion of the study.

Two small metal tubes will be inserted through the skin into the collapsed bone. Inflatable bone tamps (balloon catheters) will be inserted through each of these two tubes into the bone. The balloons will be inflated with a liquid that can be seen on xrays (contrast) to return the bone toward its natural shape and create a cavity. The balloons will then be deflated and removed. The cavity in the bone will be filled with bone cement to stabilize the broken backbone.

Vertebral Augmentation with Balloon Kyphoplasty

Non-surgical treatment means the institution of therapies other than cancer chemotherapy and surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with the patient's VCF(s).

Non-surgical Treatment

Frank Vrionis, M.D.

The purpose of this study is to find out how balloon kyphoplasty (surgical repair of the patient's fracture using balloons and bone cement) compares to non-surgical treatment in reducing vertebral compression fractures while providing pain relief and improved function and quality of life.

This is a prospective single center study designed to compare balloon kyphoplasty to non-surgical management (NSM) in the treatment of mildly painful, acute vertebral body compression fractures in multiple myeloma patients. Because of the pilot nature and the small sample size of the study, patient randomization will NOT be stratified. Patients with mildly symptomatic vertebral compression fractures (VCFs) will undergo a 1:1 randomization either balloon kyphoplasty or non surgical management. Randomization assignments will be generated by computer and investigator notified once the patient enrolled.

The observational arm will be compared to each of the other two arms; control and intervention arm using the same outcome variables and statistical methods.

Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures

A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures

Time to vertebral event (composite end point of pain progression, hospitalization for pain, and rescue vertebral augmentation or surgery or radiation therapy as related to an index fracture)

Time to pain progression defined as the time to the development of pain severity rated greater than 4 on the visual analog scale (VAS) as related to an index fracture

Rate of vertebral events in patients with asymptomatic vertebral compression fracture at 12 months

Rate of hospitalization for pain control in patients with asymptomatic or mildly symptomatic vertebral compression fracture at 12 months

Quality of life as assessed by the Functional Assessment of Cancer Treatment - General (FACT-G) questionnaire in all enrolled patients and Roland Morris disability questionnaire for spine disability

Changes in pulmonary function testing in patients with thoracic spine vertebral compression fracture

Change in kyphosis as measured by the Cobb method and change in vertebral collapse by the method of Genant

Prognostic ability of bone biomarkers for the prediction of vertebral events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer	NCT00880022	Arm Lymphedema Truncal Lymphed... Breast Cancer	Flexitouch Syst...	21 Years -	Vanderbilt University
Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2	NCT06139458	Gynecologic Can... Chemotherapy-in...	Cryotherapy Compression	18 Years -	Duke University
Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2	NCT06139458	Gynecologic Can... Chemotherapy-in...	Cryotherapy Compression	18 Years -	Duke University
Compression Anastomosis Using the Compression Anastomotic Ring-locking Procedure (CARP)	NCT01451008	Cancer Polyp	Compression ana...	18 Years - 90 Years	Region Skane
Pre-existing Factors, Early Detection and Early Treatment of Breast Cancer Related Lymphedema	NCT03210311	Lymphedema of U... Breast Cancer Diagnoses Disea...	compression	18 Years - 90 Years	Universitaire Ziekenhuizen KU Leuven
OptiBra Study, Optimal Postoperative Bra After Breastcancer Surgery	NCT04059835	Bra Breast Cancer S... Complication Compression Symptoms	OptiBra study	18 Years - 99 Years	Karolinska University Hospital
OptiBra Study, Optimal Postoperative Bra After Breastcancer Surgery	NCT04059835	Bra Breast Cancer S... Complication Compression Symptoms	OptiBra study	18 Years - 99 Years	Karolinska University Hospital
Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures	NCT01175278	Multiple Myelom...	Vertebral Augme... Non-surgical Tr...	21 Years -	H. Lee Moffitt Cancer Center and Research Institute
Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer	NCT00880022	Arm Lymphedema Truncal Lymphed... Breast Cancer	Flexitouch Syst...	21 Years -	Vanderbilt University
Pre-existing Factors, Early Detection and Early Treatment of Breast Cancer Related Lymphedema	NCT03210311	Lymphedema of U... Breast Cancer Diagnoses Disea...	compression	18 Years - 90 Years	Universitaire Ziekenhuizen KU Leuven

Spots Global Cancer Trial Database for compression

Every month we try and update this database with for compression cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for compression

Every month we try and update this database with for compression cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for compression cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.