Exercise Program for Lymphoma

Overseen By Christina Dieli-Conwright, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: R-CHOP, POLA-R-CHP

Disqualifiers: Unstable comorbidities, Other malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 12-week exercise program, called the Interrupted Sedentary Time Intervention, can benefit people with newly diagnosed lymphoma undergoing specific chemotherapy treatments. The researchers aim to determine if reducing long periods of inactivity can improve heart health and lessen chemotherapy side effects. Participants will either follow this exercise plan or continue with their usual care to compare results. This trial suits those with lymphoma who are receiving R-CHOP or POLA-R-CHP chemotherapy, engage in minimal exercise, and can travel to the Dana-Farber Cancer Institute for sessions. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance quality of life during chemotherapy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise program is safe for lymphoma patients?

Research has shown that exercise programs can be safe and beneficial for people with lymphoma. In past studies, participants handled exercise well, experiencing no serious side effects. The goal is to reduce long periods of inactivity, which can improve heart health and lessen chemotherapy side effects.

These findings suggest that the exercise program in this trial is likely safe for participants. However, individual experiences may vary, so discussing any new activity with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Interrupted Sedentary Time Intervention for lymphoma patients because it introduces a novel way to support health during chemotherapy. Unlike traditional treatments that focus solely on medication, this approach integrates regular, structured exercise sessions both in-clinic and at home. This method not only aims to improve physical fitness but also potentially enhances the overall treatment experience by reducing the negative effects of prolonged inactivity. By incorporating exercise as a complementary intervention, it offers a holistic angle in managing lymphoma, which could lead to improved patient outcomes and quality of life.

What evidence suggests that this exercise program is effective for improving heart health and reducing chemotherapy side effects in lymphoma patients?

Studies have shown that exercise can enhance the physical abilities of people with lymphoma. In this trial, participants may join the Interrupted Sedentary Time Intervention, an exercise program that research indicates may reduce tiredness, depression, anxiety, and sleep disturbances in these patients. Initial findings suggest that taking breaks from prolonged sitting by being active could also improve heart health. This is crucial because chemotherapy treatments, such as R-CHOP or POLA-R-CHP, can lead to heart problems. Regular activity might also alleviate some side effects of these treatments, helping patients manage their health during chemotherapy. ^{1 2 3 4 6}

Who Is on the Research Team?

Christina Dieli-Conwright, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for newly diagnosed lymphoma patients starting R-CHOP or POLA-R-CHP chemotherapy. It's designed to help those who lead a sedentary lifestyle. Specific eligibility criteria are not provided, but typically include being medically stable and able to participate in an exercise program.

Inclusion Criteria

Access to a phone that can receive text messages

Ability to understand and the willingness to sign informed consent prior to any study-related procedures

Engaging in ≤60-minutes of structured moderate or vigorous intensity exercise

Exclusion Criteria

Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise

Participate in more than 60 minutes of structured moderate-to-vigorous exercise per week over the last month

Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Assessments of fitness and physical health, blood tests, and questionnaires

1 week

1 visit (in-person)

Treatment

Participants receive standard of care chemotherapy and engage in a 12-week exercise program to reduce sedentary time

12 weeks

Daily exercise sessions in-clinic up to 4x weekly and at home 6 days per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Week 14 post-intervention visit

What Are the Treatments Tested in This Trial?

Interventions

• Interrupted Sedentary Time Intervention

Trial Overview The iSTAND Trial tests a 12-week exercise intervention aimed at reducing sedentary time during chemotherapy treatment for lymphoma. The goal is to see if this can improve heart health and lessen the side effects of chemotherapy.

How Is the Trial Designed?

Group I: Interrupted Sedentary Time Intervention Experimental Treatment 1 Intervention

The first 3 participants enrolled with be placed into the intervention group. After this, participants will be randomized in a group allocation ratio of 2:1 using permuted blocked design with varying block size and stratified by treatment plan. 14 participants will complete: * Baseline visit * Standard of care chemotherapy treatment regimen * Daily exercise sessions in-clinic up to 4x weekly and at home 6 days per week * Week 14 post-intervention visit

Group II: Usual Care Control Group Active Control 1 Intervention

Participants will be randomized in a group allocation ratio of 2:1 using permuted blocked design with varying block size and stratified by treatment plan. 7 participants will complete: * Baseline visit * Standard of Care chemotherapy treatment regimen * Week 14 visit * Participants will be offered Fitbit activity tracker and resistance bands at the end of the study.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

In a study of 60 lymphoma patients participating in a 12-week exercise program, adherence to the exercise regimen was high at 77.8%.

Younger patients (under 40), those with a history of insufficient physical activity, previous radiation treatment, higher body mass index, and smokers showed poorer adherence, highlighting key factors that could inform targeted interventions to improve exercise participation in lymphoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of adherence to supervised exercise in lymphoma patients participating in a randomized controlled trial. Courneya, KS., Stevinson, C., McNeely, ML., et al.[2018]

A systematic review of 11 studies with 1530 cancer patients found that supervised physical activity significantly reduces cancer-related fatigue, with a strong effect size (SMD = -1.69).

Both combined aerobic and resistance training, as well as aerobic, resistance, and stretching exercises, were effective in reducing fatigue, suggesting these should be included in cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised exercise reduces cancer-related fatigue: a systematic review. Meneses-Echávez, JF., González-Jiménez, E., Ramírez-Vélez, R.[2022]

A feasibility study involving 14 young adults (ages 20-34) undergoing chemotherapy showed that they are willing to participate in physical activity research, indicating potential for future studies.

Participants reported significant variability in their physical activity levels and experienced high levels of fatigue, suggesting a need for interventions to enhance physical activity during cancer treatment to help manage symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Study to Measure Physical Activity, Fatigue, Sleep-Wake Disturbances, and Depression in Young Adults During Chemotherapy. Erickson, JM., Adelstein, KE., Letzkus, LC.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06923397

Study Details | NCT06923397 | Interrupting Sedentary ... This study aims to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10769060/

A single-armed proof-of-concept study of Lymfit Treatments of lymphoma can lead to reduced physical functioning, cancer-related fatigue, depression, anxiety, and insomnia.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06923397/interrupting-sedentary-time-to-improve-cardiometabolic-health-and-toxicity-in-patients-with-lymphoma-receiving-chemotherapy-the-istand-trial

Interrupting Sedentary Time to Improve Cardiometabolic ... This study aims to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma ...

4. withpower.com withpower.com/trial/phase-hodgkin-disease-9-2025-eeedb

Exercise Program for Lymphoma · Info for Participants This study aims to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma participants ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/15/8/e100965.full.pdf

Clinical outcomes and interventions related to sedentary ... In this scoping review, we aim to summarise current literature on (1) the association between SB and clinical outcomes and (2) results of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9194779/

Substituting bouts of sedentary behavior with physical activity The purpose of the study is to determine the associations between WC and reallocating sedentary time to sleep, walking or MVPA in people with a ...