Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

This single-arm feasibility trial will evaluate the administration of an aggressive exercise regimen.

The Bruinicks-Osteretsky Test of Motor Proficiency Version 2 (BOT-2) will be used to measure participants' motor function. The test is norm- referenced and designed to test motor function in children and adolescents 4 -21 years of age. The motor composite score describes overall motor abilities and is comprised of fine motor control, manual coordination, body coordination, and strength and agility. We will use the total motor composite to describe overall motor function.

Gross Motor Function

Maximum isometric knee extension strength will be measured with the subject seated in an adjustable straight-back chair. The pelvis will be fixed by an adjustable strap and the knee flexed to 45 degrees. The participant will exert a maximal voluntary force until their contraction is "broken."

Knee extension strength

Hand grip strength in kilograms will be measured using a Jamar hand held dynamometer (Sammons Preston Rolyan, Nottinghamshire, UK). Participants will be seated with the shoulder at 0-10 degrees and the elbow in 90 degrees of flexion. The forearm will be positioned in neutral. Each participant will complete three trials, and the average used for analysis.

Hand grip strength

Flexibility will be measured by having the participant perform the sit and reach test. A yardstick is placed on a firm flat surface and tape is placed across it at a right angle to the 15 inch mark. The participant sits with the yardstick between the legs with legs extended at right angles to the taped line on the floor. The heels of the feet touch the edge of the taped line and are 10-12 inches apart. The participant reaches forward with both hands as far as possible, keeping the hands parallel. The best value for three trials, in centimeters, at the most distant point of the fingertips is recorded.

Flexibility

Ankle dorsiflexion active and passive range of motion will be measured with a goniometer. The goniometer is a reliable and valid measure of active and passive range of motion if the rater uses standard procedures

Ankle range of motion

Participants will complete the modified Cooper test where they walk in a corridor as fast as possible for six minutes. The distance is recorded in meters and can also be used to estimate peak V02

Aerobic capacity

Height, body mass index, waist circumference, and blood pressure will be measured.

Body composition and vital signs

Kirsten Ness, PT, PhD

Survivors of childhood leukemia have muscle weakness and impaired mobility (physical performance), a higher than expected frequency of obesity, and early mortality from cardiovascular disease. Treatment related neuropathy, cardiotoxicity and general cachexia may complicate physical performance and establish a pattern of sedentary behavior that may lead to a lifetime of inactivity. There is limited evidence that children being treated for leukemia benefit from home exercise programs during the maintenance phase of therapy, particularly in terms of muscle strength and range of motion. However, there are no established guidelines regarding the prescription of exercise for children diagnosed with leukemia. We propose to test the feasibility of an exercise intervention among children being treated for acute lymphoblastic leukemia (ALL) and hypothesize that children who participate in the exercise intervention will demonstrate improvements in gross motor function, strength, flexibility, and cardio respiratory fitness, and that they will have more favorable body composition when compared to the children who are assigned to the usual activity group.

The purpose of this trial is to determine the feasibility of an aerobic and strengthening exercise intervention trial among children during maintenance therapy for childhood ALL by evaluating participant accrual, participant compliance, and burden to the institutional staff.

We anticipate that key barriers exist which threaten the successful completion of an interventional trial of exercise within the ALL patient population. Approximately 2,500 to 3,500 children are diagnosed each year with ALL and similar numbers will enter the maintenance phase of therapy during a given year. About 22% of those diagnosed are between 5 and 8 years old. Thus accrual is limited by the small patient population but fortunately most patients with ALL receive their care at dedicated pediatric oncology institutions. Lack of interest or lack of understanding of the underlying problem of obesity and weakness among survivors in the ALL population may be additional barriers to accrual. In addition, families may be overwhelmed by the primary diagnosis of leukemia and feel that they are unable to take on additional challenges.

Compliance to a rigorous exercise regimen must be ascertained if demonstrable improvement in motor performance, body composition and cardiovascular disease risk profile are to occur. Key to this study is not only short-term compliance but designing an intervention that will promote and improve long-term rates of exercise. Barriers to compliance include length of time to complete the intervention, number of days the intervention must be administered, perceived benefit by the participant, difficulty of the intervention, inadequate demonstration of the intervention, poor understanding by the participant/parent of the importance of obesity and weakness among survivors of childhood ALL, and health issues in regard to the primary diagnosis of ALL.

We will open a feasibility study at 3 institutions dedicated to treatment of childhood cancer: St. Jude Children's Research Hospital, Oregon Health \& Science University and Vanderbilt Ingram Cancer Center .The accrual goal of this study will be a total of 20 patients. The hypothesized outcome for this aim of the feasibility study will be an accrual rate of 50% of eligible patients at a given institution.

Motor Function The Bruinicks-Osteretsky Test of Motor Proficiency Version 2 (BOT-2) will be used to measure participants' motor function. Maximum isometric knee extension strength will be measured with a hand held myometer and hand grip strength will be measured with a hand held dynamometer. Additionally, flexibility will be measured with the sit and reach test. Ankle dorsiflexion active and passive range of motion will be measures with a goniometer. Aerobic capacity will be measured with the modified Cooper 6 minute walk test. Body composition and vital signs will also be collected.

Intervention Participants will receive counseling and written material regarding the benefits of exercise and an individualized exercise instruction session based on the results of their baseline testing and their individual preferences. Each program will include ability specific stretching/flexibility, progressive resistive strengthening, and aerobic exercise. Necessary equipment for the strengthening (weights, stretch cords, elastic bands) and aerobic components will also be provided. A videotape demonstrating each exercise in the intervention will be given to the participant and their parent."

Detailed written instructions, along with a book to log exercise, will also be provided. Stickers and small toys will be provided for the parents to give to their children for completing their exercises. Participants will receive a weekly phone call from an exercise coach, to answer questions and to progress the intervention. Participants will also receive counseling and review/progression of the exercise intervention at each usual clinic visit (approximately monthly). During the pilot study, participants will continue to receive the intervention for six months, with weekly phone calls tapering to every other week after three months. The exercise coach will be available to the participant/parent as needed via phone and/or email throughout the intervention period.

Aerobic and Strengthening Exercise for Acute Leukemia

St. Jude Children's Research Hospital

Skin and Connective Tissue Diseases

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Lymphedema

Breast Neoplasms

Influenza, Human

Breast Cancer Lymphedema

Postoperative Complications

All patients were included in the complete decongestive therapy programme. This therapy includes patient education, skin care, exercises, manual lymphatic drainage (self), and compression bandage therapy.

It is given in two phases. First phase includes intensive therapy which aims to reduce the volume of the extremity. Second phase aims to preserve these reductions of volume.

All patients were prescribed lymphedema specific exercises and were advised to walk (for 30 minutes everyday) daywhile taking complete decongestive therapy. They were specifically informed that exercise does not aggravate the severity of their lymphedema.

Short stretch bandages were applied to the patients with self manual lymphatic drainage. Intensive phase was given 5 days a week, and short stretch bandages applied for 23 hours a day with 1 hour interval. To increase the local pressure on the areas required, foams were added. Patients were screened with arm circumferential measurements once a week. After gaining a plateau in the volumes, patients were prescribed compression garments.

Complete Decongestion Therapy

This study aims to find whether complete decongestive therapy used in breast cancer-related lymphedema has an effect on muscle strength in the affected arm, while assessing the efficacy of the therapy itself. 74 patients with breast cancer related lymphedema were included in this study. Patients were taken their demographic and clinical history and were evaluated with measurements of extremity volumes and hand grip strengths using a hand dynamometer before and after the complete decongestive therapy. Data were then assessed using relevant statistical methods.

Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema

Hand grip strength: Hand grip strength was measured using JAMAR® hand dynamometer. It has been used to assess hand grip strength in many studies over half a century. Patients were asked to sit down with shoulder adducted, elbow flexed (90°) and forearm in the neutral position. Mean of the 3 measurements taken with 1 minute apart from each other was recorded. Patients' measurements were taken for both affected and unaffected arm, and recorded as kgf.

Volume measurements were taken using ulnar styloid process as a index point, and circumferential measurements were taken with 5 cm spaces from distal to the proximal. Using a computer programme (Limb Volumes Professional version 5.0), the total volume of the arm was calculated and recorded before and after the treatment for both arms.

All patients' measurements were taken by the same researcher.

Ege University

Researcher in Ege University School of Medicine

Wounds and Injuries

Musculoskeletal Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Pain, Postoperative

Pain

Shoulder Pain

Surgical Wound

Breast Diseases

Skin Diseases

Neurologic Manifestations

Arthralgia

Joint Diseases

Quality of Life

Chronic Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Adjuvants, Anesthesia

Anesthetics

Anesthetics, Local

Levobupivacaine

Diclofenac

Anti-Inflammatory Agents, Non-Steroidal

Meperidine

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

All patients underwent quadrantectomy or mastectomy with axillary lymph node dissection. They received diclofenac 2 x 75 mg intravenously on the first day after surgery. During the 3 subsequent days, from day 2 to day 4 postoperatively patients were given 3 x 50 mg diclofenac tablets orally. The medicine was delivered by the nurse, and the patients drank tablets in front of her.

Group Levobupivacaine Bolus received 0.5 mg/kg 0.5% Levobupivacaine HCl every 8 h via wound catheter. The dose of levobupivacaine was prescribed by the doctor and the drug was delivered by the nurse.

Group Levobupivacaine patient-controlled analgesia (PCA) received 0.05 mg/kg 0.5% Levobupivacaine HCl continuously via wound catheter delivered by CADD - Legacy® PCA Pump. These patients were allowed to add a dose of 7.5 mg 0.5% levobupivacaine in case of pain by pressing the patient's button on the PCA pump, with a lock-out period of 4 hours.

A group of patients with breast cancer who were randomized to the diclofenac group by drawing random numbers was given 2 x 75 mg of drug IV on the first PO day and then 3 x 50 mg tablets orally for postoperative analgesia.

All patients were assessed before the surgical procedure: hand grip strength, shoulder disability, and health-related quality of life were measured. Pain relief was assessed by the visual analog scale (VAS) from 0-10.

Rescue analgesia was offered for pain \>4 on the VAS, meperidine 20-30 mg for VAS \>or = 4

Diclofenac Sodium

The levobupivacaine dose was calculated by a doctor. A wound infiltration catheter was inserted at the end of the surgical procedure by a surgeon. A first dose of local anesthetic was delivered at the end of the surgical procedure to test catheter placement. Bolus doses of local anesthetics based on the patients' body weight were thereafter delivered by the nurse in 8 hours intervals.

All patients were assessed before the surgical procedure and hand grip strength, shoulder disability, and health-related quality of life were measured. Pain relief was assessed by the visual analog scale (VAS) from 0-10.

Rescue analgesia was offered for pain \>4 on the VAS, meperidine 20-30 mg for VAS \>or = 4.

Levobupivacaine bolus analgesia

The levobupivacaine dose was calculated by a doctor. A wound infiltration catheter was inserted at the end of the surgical procedure by a surgeon. Levobupivacaine was delivered by PCA pump (CADD - Legacy® PCA Pump, Model 6300, Smiths Medical MD, Inc., St. Paul, USA). A drug delivery was started at the end of the surgical procedure.

All patients were assessed before the surgical procedure: hand grip strength, shoulder disability, and health-related quality of life were measured. Pain relief was assessed by the visual analog scale (VAS) from 0-10.

Rescue analgesia was offered for persisting pain \>4 on the VAS, and meperidine 20-30 mg for VAS \>or = 4.

Levobupivacaine PCA group

Josipa Glavas Tahtler, MD

In the study that was conducted from 05.01.2009 - 31.12.2012. 120 patients were examined. By drawing random numbers, the patients were randomized into 3 groups for postoperative analgesia:

1. Diclofenac 2 mg/kg/day - control,
2. Wound infiltration via wound catheter with catheter tip placed in the axilla, 3\*0.5 mg/kg 0.5% levobupivacaine bolus dose.
3. 0.05 mg/kg/h 0.5% levobupivacaine continuously via wound infiltration catheter with catheter tip placed in the axilla. The drug was delivered using a PCA pump for 24 hours.

The aim was to compare early postoperative outcomes - pain control on a visual analog scale of 1-10, hand grip strength, and quality of life after surgery and after 1 year.

Long-term survival was examined subsequently, from the hospital register.

Before the operation, the patients were randomized into 3 groups: the first group received diclofenac for postoperative analgesia. On the first day, they received 2 x 75 mg intravenously, and then 3 x 50 mg tablets. For the wound infiltration with levobupivacaine, a perforated catheter was placed at the end of the surgical procedure by the surgeon in both groups of patients. The tip of the catheter was in the axillary fossa, where the dissection was performed. Patients in the levobupivacaine bolus group (N=39) received three times a day bolus doses of 0.5 mg/kg 0.5% levobupivacaine (Chirocaine, Abbot S.p.A., Latina, Italy) through the catheter. The dose of levobupivacaine was prescribed by the doctor, and the drug was delivered by the nurse. In levobupivacaine, PCA group (N=40) women had the same catheter placed, but received 0.05 mg/kg/h 0.5% levobupivacaine continuously for 24 hours via a catheter placed in the axilla. Levobupivacaine was delivered by PCA pump (CADD - Legacy® PCA Pump, Model 6300, Smiths Medical MD, Inc., St. Paul, USA). These patients were allowed to add a dose of 7.5 mg 0.5% levobupivacaine in case of pain by pressing the patient's button on the PCA pump, with a lock-out period of 4 hours. Postoperative pain was measured with a visual analog scale (VAS). All patients had the option of additional analgesia, using NSAIDs for pain \<4 or meperidine for VAS \>4. After the surgery, the patients received oncological chemoradiotherapy, depending on the type and stage of cancer.

On the one-year control examination, the investigator was blinded on the type of postoperative analgesia

Female breast cancer patients were included in the study

Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia

Long-term Outcomes of Breast Cancer Patients Receiving Levobupivacaine Wound Infiltration or Diclofenac for Postoperative Pain Relief

data may be shared upon request from researchers.

Pain after mastectomy was evaluated by self-reports from patients using a Visual Analog Scale (VAS) from 0 - no pain up to 10 - the worst pain imaginable.

Hand grip strength (HGS) was measured preoperatively, 4 days after surgery and at follow-up after 1 year, using a handheld dynamometer (Dynatest®, Rud. Reister Gmbh\&CaKG, Jungingen, Germany) and expressed in bars. Mean expected normal values for female patients are in the range between 0.4-0.6 bar.

Shoulder pain was assessed using the Shoulder Disability Questionnaire (SDQ), and shoulder pain was assessed in 16 typical situations such as writing, opening a door, sleeping on the operated side, or carrying a load. The maximal score was all positive ( 16 in 16, 100%), suggesting that pain was present in all 16 clinical situations, and the minimum score is 0 (0 positive responses /16 situations, 0% - no disability in any situation.

Health-related quality of life was assessed using the Croatian version of the SF-36 questionnaire. There were eight domains examined: physical health, role limitation due to physical problems, pain, general health perception, energy / vitality, social functioning, limitations due to emotional problems, and general mental health.

This instrument summarizes health perception from the patient's perspective. SF-36 scores range from 0 (worst) to 100 (best) (5).

Survival after 5 years from the surgery will be checked through the hospital registry, or for those who died through the official population records and death registers of the Republic of Croatia. Patients' outcomes are dichotomous and are presented as alive or dead 5 years after surgery.

Survival after 10 years from the surgery will be checked through the hospital registry, or for those who died through the official population records and death registers of the Republic of Croatia. Patients' outcomes are dichotomous and are presented as alive or dead 10 years after surgery.

Osijek University Hospital

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Bisphenol A

24-hour dietary recall, hand grip strength, accelerometer, International Physical Activity Questionnaire (IPAQ), Patient-reported outcomes survey (NCI-PRO-CTCAE), Pittsburgh Sleep Quality Index (PSQI), Functional Assessment of Cancer Treatment - Lymphoma (FACT-lym), urine sample (optional), fecal sample (optional)

Dietary intake assessment conducted by a Registered Dietitian Nutritionist. This assessment will occur prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

24-hour dietary recall

Measurement of grip strength using a hand dynamometer. This will test occur prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

Survey about physical activity over the previous 7 days. This survey will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

International Physical Activity Questionnaire

Survey about symptoms and side effects experienced during cancer treatment. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

Patient-reported outcomes survey

Survey about sleep habits and quality over the past month. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

Pittsburgh Sleep Quality Index

Survey about quality of life for people with a diagnosis of lymphoma. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

Functional Assessment of Cancer Treatment - Lymphoma

Collect three urine samples either in the clinic or at home. This specimen collection will occur prior to starting R-CHOP chemotherapy, after the third round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

urine sample (optional)

Collect a fecal sample either in the clinic or at home. This sample collection will occur prior to starting R-CHOP chemotherapy, after the third round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

fecal sample (optional)

Kim Robien, PhD, RD

In this pilot study, observational data will be collected to describe the usual trajectory of changes in dietary intake, ability to be physically active, body composition, environmental exposures, and the gut microbiome over the course of R-CHOP treatment for non-Hodgkin lymphoma (NHL).

Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is the "gold standard" first-line treatment for patients with non-Hodgkin lymphoma, yet it is estimated that R-CHOP is not curative for 30- 50% of patients. Preliminary studies suggests that modifiable lifestyle factors such as body composition, exposure to endocrine disrupting chemicals, and changes in the gut microbiome may contribute to variation in R-CHOP treatment response. If true, it could be possible to modify these factors in an effort to improve treatment outcomes, however more detailed information is needed to confirm these preliminary findings and test whether lifestyle modification can improve outcomes.

In this observational study, data will be collected on dietary intake, ability to be physically active, body composition, environmental exposure to endocrine disrupting chemicals and changes in the gut microbiome over the course of R-CHOP for NHL. The study will provide more detailed information on the usual trajectory of these lifestyle factors during R-CHOP treatment than has previously been collected, especially how these factors co-vary over time. The study findings are expected to inform future intervention studies aimed at improving R-CHOP treatment outcomes.

urine, fecal samples (optional component of the study)

Diet, Physical Activity and Body Composition Changes During R-CHOP

Prospective Observational Study of Diet, Physical Activity and Body Composition Changes During R-CHOP Treatment for NHL

Will not share data until study is complete and all data deidentified

change in kilograms of lean body mass as measured from staging CT-scans from pre- to post-R-CHOP chemotherapy.

change in adipose tissue volume (cm\^3) as measured from staging CT-scans from pre- to post-R-CHOP chemotherapy.

Change in total energy intake (kcal/day) from pre- to post-R-CHOP chemotherapy.

Change in dietary protein intake (g/day) from pre- to post-R-CHOP chemotherapy measured by diet history.

Change in daily metabolic equivalents (MET) of physical activity as measured by accelerometer from pre- to post-R-CHOP chemotherapy.

percent of change in urinary bisphenol levels (ng/mL) as measured by liquid chromotography-tandem mass spectrometry from pre- to post-R-CHOP chemotherapy

percent of change in urinary phthalate levels (ng/ML) as measured by liquid chromotography-tandem mass spectrometry from pre- to post-R-CHOP chemotherapy

Change in species and type of gut microbiota from pre- to post-R-CHOP chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Aerobic and Strengthening Exercise for Acute Leukemia	NCT00766311	Acute Lymphobla...	Gross Motor Fun... Knee extension ... Hand grip stren... Flexibility Ankle range of ... Aerobic capacit... Body compositio...	5 Years - 10 Years	St. Jude Children's Research Hospital
Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema	NCT03945838	Lymphedema Arm Lymphedema; Sur...	Complete Decong...	18 Years - 70 Years	Ege University
Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia	NCT05829707	Postoperative A... Hand Strength Health Related ... Chronic Shoulde... Breast Cancer F... Surgical Wound ... Lymph Node Diss...	Diclofenac Sodi... Levobupivacaine... Levobupivacaine...	30 Years - 75 Years	Osijek University Hospital
Diet, Physical Activity and Body Composition Changes During R-CHOP	NCT04293900	Non-Hodgkin Lym... DLBCL Diffuse Large B...	24-hour dietary... Hand grip stren... International P... Patient-reporte... Pittsburgh Slee... Functional Asse... urine sample (o... fecal sample (o...	18 Years -	George Washington University
Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema	NCT03945838	Lymphedema Arm Lymphedema; Sur...	Complete Decong...	18 Years - 70 Years	Ege University

Spots Global Cancer Trial Database for hand grip strength