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

24 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Interrupted Sedentary Time Intervention for lymphoma?

Research shows that being physically active improves survival rates and quality of life for lymphoma patients. Increasing physical activity after diagnosis is linked to better overall survival and lymphoma-specific survival, suggesting that interventions like Interrupted Sedentary Time could be beneficial. ^{1 2 3 4 5}

Is exercise safe for lymphoma patients?

Exercise programs, including aerobic exercise, appear to be safe for lymphoma patients and can improve fitness and reduce fatigue. Studies suggest that exercise is feasible and beneficial for lymphoma patients, with no major safety concerns reported. ^{2 4 6 7 8}

How does the exercise program treatment for lymphoma differ from other treatments?

The exercise program for lymphoma is unique because it focuses on improving physical activity and fitness to enhance survival outcomes and reduce fatigue, rather than using medication or traditional therapies. This approach is novel as it aims to break the cycle of fatigue and inactivity, which is common in lymphoma patients, and improve overall quality of life. ^{1 4 6 8 9}

What is the purpose of this trial?

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 receiving R-CHOP or POLA-R-CHP chemotherapy treatments, and whether it can improve heart health and reduce chemotherapy drug side effects.

Research Team

Christina Dieli-Conwright, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Evidence-based exercises intervention in adults diagnosed with Lymphoma. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Physical activity and quality of life in adult survivors of non-Hodgkin's lymphoma. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Supervised exercise reduces cancer-related fatigue: a systematic review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The association of physical activity before and after lymphoma diagnosis with survival outcomes. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Daily physical-rest activities in relation to nutritional state, metabolism, and quality of life in cancer patients with progressive cachexia. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Predictors of follow-up exercise behavior 6 months after a randomized trial of supervised exercise training in lymphoma patients. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. Germany pubmed.ncbi.nlm.nih.gov

Physical activity, physical fitness and the effect of exercise training interventions in lymphoma patients: a systematic review. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Predictors of adherence to supervised exercise in lymphoma patients participating in a randomized controlled trial. [2018]