Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Edema

Brain Neoplasms

Astrocytoma

Brain Edema

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Chronic Graft Versus Host Disease

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Dexamethasone acetate

BB 1101

Adrenocorticotropic Hormone

Corticotropin-Releasing Hormone

Hormones

Hormone Antagonists

Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.

Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking

hCRF ; open-label dexamethasone that the patient is currently taking

hCRF

placebo hCRF 2mg/day and open-label dexamethasone that they are taking

placebo hCRF

William Shapiro, MD

The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms.

XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.

XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors

A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone

The primary efficacy endpoint was the proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Week 5. Responders were defined as study patients who demonstrated the following:

* 50% or greater reduction in dexamethasone dose relative to Baseline
* Overall 10-Item Neurological Examination Score unchanged or lower compared to Baseline
* Karnofsky Score unchanged or increased relative to Baseline

• The proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Weeks 5 and 8.

Change from Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week follow-up visit). Each item is scored from 0 (normal) to 4 (severely abnormal) except for speech (0-3) for a total range of 0-39. Total score for each patient was the sum of each item score. Change is calculated as the follow-up score minus the baseline score; a negative value indicates improvement.

Change from Baseline in the Karnofsky Performance Score at Weeks 2, 5, 8, 12 and 16.The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death. Although practitioners occasionally assign performance scores in between standard intervals of 10 as follows:

100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs.

50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.

20 - Very sick; hospital admission necessary; active supportive treatment nec

The FACT-Br Quality of Life Questionnaire was self-administered at Baseline, Weeks 5 and 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up).FACT-Br is a reliable and valid 50-item measure that includes FACT-G (27 items) and a brain subscale (23 items) to assess health-related quality of life in brain tumor patients. Each inventory question is scored from 0 (worst possible QOL) to 4 (best possible QOL)

Myopathy, using Kendall Myopathy Scale, was assessed at Baseline, Week 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up). The Kendall Myopathy Scale is a 10 point scale where 10 represents holding test position against strong pressure (best) and 0 represents no contraction palpable (worst).

The maximum reduction in dexamethasone usage at any time during the study. Dexamethasone dosage was assessed at Weeks 0, 2, 5, 8, 12 and 16.

Numbers of patients who discontinued prior to the Week 5 assessment

Neurobiological Technologies

Celtic Pharma Development Services

Treatment-emergent adverse events (TEAEs) excluded steroid-related conditions noted on the medical history. One patient was randomized to placebo but was administered hCRF instead. For the assessment of safety, the patient data has been included based on the treatment administered rather than that originally randomized.

Placebo

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Canada

Australia

New Zealand

Region of Enrollment

Patrick O'Connor, MD, Managing Director Clinical Development

The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5

Percent of Patients in Each Treatment Group Achieving 50% Reduction in Dexamethasone Usage Relative to Baseline by Week 2 Without Deterioration in Neurological Function as Measured by the 10-Item Neurological Exam and the KPS

Week 2

Week 5

Week 8

The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Who Continue to be Responders at Weeks 5 and 8

Week 12

Last Visit

Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation)

Change From Baseline in the Karnofsky Performance Score

Week 16

Change From Baseline in the FACT-Br Quality of Life Results

Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit)

Intent to Treat population; baseline observation carried forward

Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study

Number of Patients Who Discontinued Study Drug Prior to the End of Week 5

Overall Study

Wounds and Injuries

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Fractures, Bone

Contracture

Radius Fractures

Hand Injuries

Dupuytren Contracture

Wrist Fractures

Forearm Injuries

Arm Injuries

Wrist Injuries

Joint Diseases

Muscular Diseases

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Connective Tissue Diseases

Coagulants

Central Nervous System Depressants

Anti-Infective Agents

Tranexamic Acid

Anesthetics

Anti-Bacterial Agents

Antibiotics, Antitubercular

Hemostatics

Antifibrinolytic Agents

Patients in the TXA arm will receive 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride before their surgery and 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride 3-6 hours after the first dose on the day of their surgery

Patients in the (SOC) arm will receive 50cc of IV Placebo (standard intravenous normal saline fluid - 0.9% sodium chloride) before their surgery and 50cc of IV Placebo (standard intravenous normal saline fluid - 0.9% sodium chloride) 3-6 hours after the first dose on the day of their surgery

Patients will receive 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride before your surgery and 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride 3-6 hours after your first dose on the day of your surgery

Tranexamic acid

This will include regional anaesthesia, tourniquet inflation to 250mmHg and perioperative antibiotics. At the conclusion of the procedure hemostasis will be achieved followed by standard closure technique. There will be three separate surgical groups that will undergo the outlined study protocol: 1) Distal radius fractures will be treated with open reduction from a volar approach only technique 2) Mild dupuytren's: a. Low: i. MCP joints \<50 contracture ii. PIP joints \<40 contracture b. 1-2 fingers involved 3) Severe dupuytren's a. High: i. MCP joints \>50 degree contracture ii. PIP Joints \>40 degrees contracture b. \>2 fingers involved

Surgery

Hand edema following hand surgery is a common yet devastating side effect that can lead to early stiffness, prolonged rehabilitation and diminished function. These factors can reduce a patient's quality of life; mounting to an overall delay in recovery, return to work and daily activities. Conventional edema therapy includes cryotherapy, external compression, active and passive exercises and various types of massage. However, there is little evidence to suggest these modalities are effective. Tranexamic acid (TXA) is an antifibrinolytic that has been used in surgical disciplines for decades to aid in reducing intraoperative blood loss and consequent transfusions. Recently, the use of TXA for curbing post-operative edema and ecchymosis has shown promising results, however, its use in hand surgery has not been studied.

A Prospective, Randomized Controlled, Double-Blinded Pilot Study

The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery

The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery (THAW): A Prospective, Randomized Controlled, Double-Blinded Pilot Study

Assess number of patients who receive hand volume measurements at all designated time intervals. The outcome goal will be 90%

Asses proportion of patients who correctly receive the intervention as per the protocol. The outcome goal will be 90%

Proportion of participants to complete the study protocol and associated follow up. The outcome goal will be an 80% retention rate

Number of patients recruited to the study per month. The outcome goal will be 5 patients per month

Hand volume will be assessed using two validated methods; water displacement and figure of eight measurement.

Patient Reported Wrist and Hand Evaluation (PRWHE). The PRWHE allows patients to rate their levels of hand and wrist pain and disability. It is rated on a 0-100 scale. A higher score in the scale denotes a worse outcome

Ruby Grewal

Co-director of the clinical research lab within the Roth | McFarlane Hand and Upper Limb Center (HULC)

Heart and Blood Diseases

Substance Related Disorders

Breast Neoplasms

Cicatrix

Inflammation

Adenocarcinoma

Cardiotoxicity

Carcinoma

Neoplasms, Glandular and Epithelial

Breast Diseases

Skin Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Paaladinesh Thavendiranathan, MD

Bernd Wintersperger, MD

Breast cancer is the most common cancer amongst Canadian women. 15-20% of early breast cancers have high levels of a protein called HER2 which is associated with worse survival. Treatment of these patients with anthracyclines followed by trastuzumab (which targets HER2) improves survival. Unfortunately, these medications together can cause heart muscle injury resulting in heart dysfunction or failure in about 14% and 3.6% of the patients, respectively. Once heart failure (HF) occurs, about 60% of patients will not live past 2 years. Studies have suggested that patients with heart injury caused by anthracyclines may be more likely to develop HF with addition of trastuzumab. Therefore tests to find early heart injury after anthracyclines may allow doctors to start heart protective medications with the hope of preventing HF. Also, animal and small patient studies have shown that an increase in the water levels of the heart muscle (edema) may be an early sign of heart injury from anthracyclines. Cardiac MRI is a unique technique that has been shown to detect edema in various heart diseases.

The investigators will test the theory that, in women receiving treatment for breast cancer, heart edema detected by MRI at the end of anthracyclines will identify patients who will later develop heart dysfunction. MRI studies with novel techniques will be done pre-therapy, after anthracyclines, during herceptin, and at end of all therapy. The investigators will compare patients with and without heart dysfunction to test if patients with heart dysfunction are more likely to have edema after anthracyclines. Ultimately the investigators hope to use cardiac MRI to identify high risk patients and study various heart protective medications to prevent HF. This will improve the personal health of cancer patients by allowing them to live free of heart disease after their cancer therapy. Ultimately at a population level this will allow doctors to provide care that can be uniquely designed for each patient based on their individual risk.

The first 136 patients enrolled are included in the first part of the study, named EMBRACE-MRI 1. Enrollment for this part of the study is complete.

The remaining 44 patients will be enrolled into EMBRACE-MRI 2, which includes slight differences in obtaining sequences in MRI imaging.

Evaluation of Myocardial Changes During BReast Adenocarcinoma Therapy to Detect Cardiotoxicity Earlier With MRI

Evaluation of Myocardial Changes During BReast Adenocarcinoma Therapy to Detect Cardiotoxicity Earlier With MRI - The EMBRACE MRI Study

Myocardial edema is defined as an 8% increase in segmental T2 values measured in milliseconds in at least 2 myocardial segments at either of the 2 early time points. Cardiotoxicity is defined as Cardiac Magnetic Resonance Imaging (CMR) measured (1) ≥5% absolute reduction in Left Ventricular Ejection Fraction (LVEF) from baseline to an LVEF \<55% with signs or symptoms of HF, OR (2) a ≥10% absolute reduction in LVEF from baseline to \<55% without accompanying signs or symptoms at the time points when CMR is obtained OR (3) the same amount of reduction in LVEF as above, identified by echo at any time point (done every 3 months) and confirmed by CMR at that time.

Canadian Institutes of Health Research (CIHR)

University of Toronto

University Health Network, Toronto

Blood and Lymph Conditions

Behaviors and Mental Disorders

Pain

Lymphedema

Lymphatic Diseases

Quality of Life

Wearing a compression 4 days/weel with a minumum of 6 hours per day

Compression vest, Thuasne

A common complication of breast conserving therapy is breast edema, which may lead to chronic pain, but also reduced quality of life (QoL) and poor cosmetic outcome. When pain is present most patients are currently treated with physical therapy, but evidence of its effectiveness is still low and a gold standard does not yet exist. A downside of physical therapy is that patients have to undergo the therapy regularly and treatment might even has to continue for years after symptoms and treatment started. Another treatment option is a compression vest with the potential, apart from reducing symptoms, to improve self-efficacy in patients because they decide when to wear it without the need to visit therapists. However effectiveness of the compression vest has not yet been objectified in studies.

The aim of this pilot study is to study if there is an effect on pain, QoL and the amount of breast edema of wearing a compression vest, in order to determine whether a large randomized study is feasible.

In this pilot study, a maximum of 40 patients with symptomatic breast edema after surgery and/or radiotherapy for breast cancer are offered treatment with a compression vest. These patients will be followed for 6 months. Recruitment will continue until 20 active vest users are participating.

Primary endpoint is the course of patient reported pain over a 6 month period. Secondary endpoints are the course of degree of breast edema and quality of life over a 6 month period.

Patients who are wearing the vest may experience relief of breast edema related symptoms. In terms of burden, they might experience a tight feeling on the skin while wearing the vest, which could also be the case when treated with compression therapy and taping by a physical therapist. This tight feeling can be overcome by changing the vest to a larger size. All patients will fill out questionnaires upon inclusion, at 2 weeks, and 1, 3 and 6 months. This will take approximately 10-15 minutes per follow-up moment. Patients will have to visit the hospital at baseline and 1, 3 and 6 months after they started wearing the vest (i.e. 25 minute consult with physical examination, photo documentation of the breast and short basic follow-up questions), and it is expected that additional measurements for fitting a new compression vest will need to be taken 2-5 times during participation in the study. Those fitting measurements will be performed at a location as desired by the patient (e.g. UMC Utrecht or at patients' home).

Breast Edema Compression Vest

The Effect of Wearing a Compression Vest on Patient Reported Pain, Quality of Life and Degree of Breast Edema.

Brief Pain Inventory (BPI) for pain questionnaire

During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered.

EORTC QLQ-C30 for quality of life and breast edema symptoms

EORTC QLQ-BR23 for quality of life and breast edema symptoms

Thuasne

UMC Utrecht

MD, PhD student

Seroma

Patients who belong to the sperimental group ("SPER") will receive the standard treatment and Kinesio tape lymphatic drainage technique application.

The experimental group also receives the expected standard treatment, consisting in physiotherapeutic evaluation and physiotherapy counseling.

Patients who belong to the control group ("CONTR") will receive only the standard treatment. Standard treatment consists in physiotherapy evaluation and counseling. The educational part, the demonstration of the exercises and the prosthesis mobilization are included in this treatment.

Kinesio Tex Tape strips are applied following Dr.Kase draining techinique. The choice of tape's length and strips' number is based on the area of breast edema and/or presence of seroma, which must be completely covered. The patch is cut into fan strips. The major base is positioned near the functioning lymph node stations closest to the edema and/or seroma area. The bases and the tails of the fan must be applied with zero tension, while for the central part is reached 15-25% of tension. The first application takes place on the 1st post-operative day, while the second is performed on the 7th post-operative day. In case the tape is detached from one application to another, it is necessary that the patient resume in the clinic for a new application to ensure continuity of the therapeutic effect; otherwise the patient is eliminated from the study. The experimental group also receives the expected standard treatment, consisting in physiotherapeutic evaluation and counselin.

Kinesio tape lymphatic drainage technique application

Stefano Martella

Over the last two decades in the field of oncology, the prevention, diagnosis, treatment and rehabilitation have reached a remarkable development, improving healing rates and reducing the number of deaths from cancer. The most frequent cancer in the female population is the breast one, which consequences can become disabling. In recent years, surgeons need to find more effective and less invasive treatments. Nowadays, despite the achievements, oncological surgery can cause side effects that cannot allow the return to normal life. Some of these problems are represented by the formation of edema and seroma, which can be handled by the physiotherapist through the manual lymphatic drainage and the application of an elastic tape. The elastic tape is used a lot in clinical practice, despite it lacks supportive evidence.

The primary aim of the study is to verify the effectiveness of Kinesio Tex Tape in reducing edema and seroma formation following complex reconstructive breast surgery. The secondary goals are the evaluation of the quality of the scar, of the perception of pain, of the degree of satisfaction and disability.

It is a controlled, monocentric, national, comparative, randomized, single-blind study. The sample size is 60 patients who undergo complex reconstructive breast surgery. Patients are divided into two groups: the experimental one (receiving standard treatment and Kinesio Tex Tape application) and a group of control (just receiving standard treatment). To evaluate edema and seroma, ultrasound is used; ultrasounds will be on the 1st, 15th and 30th postoperative days (T0, T1 and T2); Vancouver Scar Scale is used to define the quality of the scar (T0 and T2); to measure the subjective perception of pain and to evaluate the degree of patient satisfaction, two VAS scales are administered (the VAS scale for pain is administered at T0, T1 and T2, while the VAS scale for satisfaction is given at T1 and T2); Finally, to assess the degree of disability, the DASH Questionnaire is used (T0, T1 and T2).

Screening at the first evaluation:

The anamnesis for each potentially eligible patient will be performed to assess whether the inclusion and exclusion criteria are met.

If the selection criteria for inclusion in the study are met, the patient will be proposed to participate in the study with the delivery of the patient information sheet and the form will be delivered to obtain written and signed informed consent.

Only after having signed the signature on the form, the patient will in fact be eligible for the study.

Randomization assigns to each patient the treatment strategy assigned by the random process, as well as the numerical code that uniquely identifies the patient in the study.

Once the randomization has been carried out, the following information will be collected at the moment before the tape application:

* Name and surname.
* Age.
* Profession.
* Type of surgical intervention.
* Side of the surgical intervention.
* Previous or concurrent diseases.
* Eventual adverse events.
* Thickness of skin and subcutaneous tissue, detected by ultrasound.
* Thickness of liquid, detected by ultrasound.
* Pain referred by the patient (VAS Scale).
* Patient satisfaction level (VAS Scale).
* Scar quality measured by the blind surgeon (Vancouver Scar Scale)
* Disability of the patient (DASH Questionnaire)

Screening for subsequent evaluations:

The following information will be collected:

* Thickness of skin and subcutaneous tissue (edema) and serum collection (seroma) detected by ultrasound.
* Quality of the scar measured by the blind surgeon (Vancouver Scar Scale).
* Subjective pain sensation (VAS Scale).
* Patient satisfaction level (VAS Scale).
* Disability of the patient (DASH Questionnaire).

Treatment:

Kinesio Tex Tape strips are applied to the patient in the experimental group following the technique of Dr. Kenzo Kase for lymphatic drainage. The choice of tape's length and of strips' number to be applied is based on the area of the breast edema and / or presence of seroma, which must be completely covered. The patch is cut into a fan strip: a length of kinesio tex tape is solid at one end and cut to create 4-6 narrow strips or tails. Corners are rounded to prevent detachment. The application area must be clean and dry. The major base is positioned near the functioning lymph node stations closest to the edema and / or seroma area. The bases and the tails of the fan must be applied with zero tension, while for the central part is reached 15-25% of tension, which is created manually or by extending the structures involved. Tails are applied in parallel, with a small distance between them.The first application takes place on the 1st post-operative day, while the second is performed on the 7th post-operative day. In the event that the tape is detached from one application to another, it is necessary that the patient resume in the clinic for a new application, so as to ensure continuity of the therapeutic effect; otherwise, the patient is eliminated from the study. The experimental group also receives the expected standard treatment. By standard treatment we mean physiotherapeutic evaluation and physiotherapy counseling. The educational part, the demonstration of the exercises to be performed autonomously and the demonstration of prosthesis mobilization are included in this treatment.

Temporary or ultimately treatment interruption:

There are no conditions that allows to interrupt and then restart the study. If a subject decides to interrupt the study, the decision will be ultimate and a conclusion visit will be carried out in order to understand the drop out motivations; data will be analysed for intention-to-treat analysis.

• Statistics considerations

Sample size:

In order to assess the 1st co-primary endpoint (seroma resolution at 30 days) the percentages will be compared; from our clinical experience we except the 50% of subjects without tape will resolve seroma at 30 days, while 90% of subjects with kinesio-tape treatment will resolve at the same time.

In order to highlight this difference we will need to recruit 30 subjects per group with 2,5 % alpha error and 80% statistical power.

Regarding the 2nd co-primary endpoint (edema reduction), taking as reference the mean of five ultrasound breast acquisition, a size of 30 subjects in each group and a 80% statistical power will be required to determine a difference of 1.69 mm between null hypothesis which establishes the mean of both groups is 10.00 mm and alternative hypothesis establishing the 2nd group mean is 8.31 mm, taking a standard deviation of 2.00 mm for both groups.

• Statistics analysis

Demographics data and outcomes in the study will be analysed through descriptive statistics.

In case of Gaussian distribution, the continuous variables will be described through mean and standard deviation, while in case non-Gaussian distribution the continuous variables will be described through median and interquartile range. Categorical variables will be described through frequency percentages.

Considered variables' normal distribution will be verified through Shapiro-Wilk Test.

For the 1st co-primary endpoint (seroma resolution) at 30 days proportions will be compared, and in order to make the survival analysis seroma resolution times will be considered.

Curves will be estimated through Kaplan and Meier method and two groups comparison will be carried out through log-rank test.

For the 2nd co-primary endpoint (edema reduction) means at 30 days will be compared through repeated measures analysis of variance.

The analysis will be conducted through intention-to-treat population analysis, considering the two groups as randomized.

Also a confirmation analysis will be conducted on population who has correctly carried out the treatment (per-protocol population).

• Ethical and regulating considerations:

This clinical study will be conducted according to the main laws drawn up by the 18th World Medical Assembly (Helsinki, 1964) and to all the applicable amendments drawn up by World Medical Assembly, and to the ICH guide lines for Good Clinical Practice.

This clinical trial will conducted with reference to all international laws and regulations, and to national laws and regulations in force in the Nation where it is carried out, as well as to each applicable guide line.

• Informed consent:

The investigator, or a person appointed by him and under his responsibility, will inform exhaustively participants about all aspects pertaining to the clinical trial, according to all the applicable regulating dispositions.

All participants will be exhaustively informed about the study, using words and language they will be able to understand.

Before taking part to the clinical trial the subjects will have had signed the informed consent forms.

The patients will be told they will be able to drop out the study whenever they want, without any requested explanations, and that their decisions will not have any consequence.

Every informed consent will be included in the investigator's files. The patient will be given a dated and signed copy of informed consent.

Kinesio Tex Tape in Reducing Edema and Seroma After Complex Reconstructive Breast Surgery

Effectiveness of Kinesio Tex Tape Application in Reducing Edema and Seroma Formation Following Complex Reconstructive Breast Surgery

Quantity of edema is measured in millimetres, through ultrasound scan. The verification of the effectiveness of elastic tape in terms of reduction of edema will be performed through ultrasound.

During the ultrasound acquisition patients are indicated to assume the supine position on the couch, with 45 ° of humerus flexion and abduction, supported by an operator . Five points of maximum thickness of skin and subcutaneous tissue (edema) will be detected : retroareolar space, Upper-outer quadrant, Upper-inner quadrant, Lower-outer quadrant and Lower-inner quadrant. The thickness will be measured in millimeters.

Quantity of seroma is measured in millimetres, through ultrasound scan. The verification of the effectiveness of elastic tape in terms of resolution of seroma will be performed through ultrasound.

During the ultrasound acquisition patients are indicated to assume the supine position on the couch, with 45 ° of humerus flexion and abduction, supported by an operator . Five points of maximum thickness of liquid (seroma) will be detected : retroareolar space, Upper-outer quadrant, Upper-inner quadrant, Lower-outer quadrant and Lower-inner quadrant. The thickness will be measured in millimeters.

The surgeon will make the evaluation of the quality of the scar using the Vancouver Scar Scale. The scale includes the following subscales: Pigmentation (M) in which the best score is "0 = normal" and the worst is "2= Hyperpigmented" , Pliability (P) in which the best score is "0 = normal" and the worst "5 = contracture", Height (H) in which the best score is " 0 = flat" and the worst is "3 = \> 5 mm" and Vascularity (V) in which the best score is "0 = normal" and the worst is "3 = purple. The subscales' scores are summed to compute a total score, where lower values represent a better quality of the scar.

The subjective perception of pain will be measured using Visual Analogue Scale for Pain. It is a measurement tool mainly used to indicate subjective pain characteristics. It consists of a strip of 10 cm in which its extremities correspond respectively to " 0 = no pain", "10 = worst pain that I can imagine", where lower values indicate a good subjective perception of pain. The health professional asks the patient to mark the pain perceived at that moment on the scale.

The degree of patient satisfaction will be measured using Visual Analogue Scale. It consists of a strip of 10 cm in which its extremities correspond respectively to "0 = no satisfaction", "10 = maximum satisfaction", where higher values indicate a good degree of satisfaction. The health professional asks the patient to mark the satisfaction perceived at that moment on the scale.

The degree of disability will be measured using DASH scale (The Disability of the Arm, Shoulder and Hand). It is a questionnaire concerning symptoms and abilities to perform certain activities that mainly require the use of the upper limb. For each subscale (30 items) the best score is "1 = no difficulty" and the worst is "5 = unable". The patient is asked to assign a score from 1 to 5 for each activity reported by referring only to the operated side. For the activities contraindicated by the surgeon patients are suggested to give score 5, "unable".

On the 15th and 30th post-operative day the questions related to the activities of daily life refer to the past week, while on the 1st post-operative day the patients are required to consider the time passed since the intervention. The subscales' scores are summed to compute a total score, where lower values represent a lower degree of disability.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors	NCT00088166	Brain Edema Brain Tumor	hCRF placebo hCRF	18 Years -	Celtic Pharma Development Services
The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery	NCT04907812	Hand Injuries a... Distal Radius F... Dupuytren Contr...	Tranexamic acid Surgery	18 Years -	Lawson Health Research Institute
Evaluation of Myocardial Changes During BReast Adenocarcinoma Therapy to Detect Cardiotoxicity Earlier With MRI	NCT02306538	Breast Neoplasm...		18 Years -	University Health Network, Toronto
Breast Edema Compression Vest	NCT02627976	Edema Lymphedema Breast Neoplasm Breast Cancer	Compression ves...	18 Years -	UMC Utrecht
Evaluation of Myocardial Changes During BReast Adenocarcinoma Therapy to Detect Cardiotoxicity Earlier With MRI	NCT02306538	Breast Neoplasm...		18 Years -	University Health Network, Toronto
Kinesio Tex Tape in Reducing Edema and Seroma After Complex Reconstructive Breast Surgery	NCT03477565	Breast Cancer Mastectomy Breast Implanta... Edema Seroma	Kinesio tape ly...	18 Years -	IRCCS San Raffaele
Evaluation of Myocardial Changes During BReast Adenocarcinoma Therapy to Detect Cardiotoxicity Earlier With MRI	NCT02306538	Breast Neoplasm...		18 Years -	University Health Network, Toronto
Sub-Tenon Triamcinolone in the Prevention of Radiation-Induced Macular Edema	NCT00441662	Melanoma	Sub-Tenon triam...	18 Years -	Wills Eye
LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)	NCT04606030	Lymphedema Edema	BioBridge® Coll... Vascularized Ly...	18 Years - 75 Years	Fibralign Corporation
Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma	NCT01805453	Newly-diagnosed...	Losartan Placebo	18 Years -	Assistance Publique - Hôpitaux de Paris
Screening For BCRL In Targeted Therapy For Breast Cancer	NCT05142800	Lymphedema Lymphedema Arm Lymphedema of U... Lymphedema of U... Lymphedema of t... Edema Edema Arm Breast Cancer L... Breast Cancer M... Breast Cancer S... Breast Cancer	Perometer SOZO device	18 Years - 80 Years	Massachusetts General Hospital
XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors	NCT00088166	Brain Edema Brain Tumor	hCRF placebo hCRF	18 Years -	Celtic Pharma Development Services

Spots Global Cancer Trial Database for edema

Every month we try and update this database with for edema 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 edema

Every month we try and update this database with for edema 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 edema 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.