Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Lymphoma, Hodgkin; Lymphoma; Lymphoma, Non-Hodgkin; Sedentary Behavior

Treatments: Behavioral: Interrupted Sedentary Time Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06923397

24-765

Details and patient eligibility

About

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.

Full description

The purpose of this study is 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.

Participants will be randomized into one of two groups: Group A: Interrupted Sedentary Time Intervention vs. Group B: Usual Care Control Group. Randomized means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, assessments of fitness and physical health, blood tests, and questionnaires.

Participation in this research study is expected to last about 3 months.

It is expected that about 24 people will take part in this research study.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to understand and the willingness to sign informed consent prior to any study- related procedures.
• Patients diagnosed with lymphoma.
• Will receive first line R-CHOP or POLA-R-CHP chemotherapy regimens, patients do not need to be within a certain timeframe from diagnosis.
• Aged ≥18 years; due to the rarity of the disease in those <18 years, this age bracket will not be included.
• Engaging in ≤60-minutes of structured moderate or vigorous intensity exercise.
• Have physician clearance to participate in exercise.
• Speak English.
• Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions.
• Access to a phone that can receive text messages.

Exclusion criteria

• Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities likely require supervised exercise for safety, and part of this study involves unsupervised exercise; therefore, for safety reasons, these persons are excluded.
• Participate in more than 60 minutes of structured moderate-to-vigorous exercise per week over the last month. Excess additional exercise is a confounding factor in assessing the effect of the current interrupted sedentary time intervention.
• Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting lymphoma chemotherapy-related effects.
• Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study.
• Unable to travel to DFCI Longwood campus for necessary data collection and chemotherapy infusions.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Interrupted Sedentary Time Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Interrupted Sedentary Time Intervention

Usual Care Control Group

No Intervention group

Description:

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.