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

NCT ID: NCT06923397

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-05

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphoma Lymphoma, Hodgkin Lymphoma, Non-Hodgkin Sedentary Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Interrupted Sedentary Time 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 Type EXPERIMENTAL

Interrupted Sedentary Time Intervention

Intervention Type BEHAVIORAL

A 12-week, semi-supervised exercise intervention comprised of reminder prompts, counseling, and activities of walking, cycling, and resistance band exercise for at-home and in-clinic settings. Supervision will be under an exercise trainer. Resistance bands, Libre Pro continuous blood sugar monitor, and Fitbit and ActivPAL trackers will be provided to participants.

Usual Care Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Interrupted Sedentary Time Intervention

A 12-week, semi-supervised exercise intervention comprised of reminder prompts, counseling, and activities of walking, cycling, and resistance band exercise for at-home and in-clinic settings. Supervision will be under an exercise trainer. Resistance bands, Libre Pro continuous blood sugar monitor, and Fitbit and ActivPAL trackers will be provided to participants.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Christina Dieli-Conwright, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christina Dieli-Conwright, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christina Dieli-Conwright, MD, PhD

Role: CONTACT

617-582-8321

Facility Contacts

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Christina Dieli-Conwright, MD, PhD

Role: primary

617-582-8321

Other Identifiers

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24-765

Identifier Type: -

Identifier Source: org_study_id