Clinical trial NCT06923397: Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial
Official title: Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lymphoma
Lymphoma, Hodgkin
Lymphoma, Non-Hodgkin
Sedentary Behavior
Keywords: Lymphoma
Hodgkin Lymphoma
Lymphoma, Hodgkin
Lymphoma, Non-Hodgkin
Non-Hodgkin Lymphoma
Sedentary Behavior
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intervention Completion Rate (Feasibility)
timeFrame: 12 weeks
measure: Refusal Rate
timeFrame: 12 weeks
measure: Retention Rate
timeFrame: 13 weeks
measure: Acceptability of Intervention Measure (AIM) Scale
timeFrame: 13 weeks
measure: Acceptability Exit Survey
timeFrame: 13 weeks
Secondary outcomes:
measure: Participant Glucose Level
timeFrame: Assessed for one week at each timepoint (baseline & post-intervention).
measure: Participant Insulin Resistance
timeFrame: Assessed for one week at each timepoint (baseline & post-intervention).
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christina Dieli-Conwright, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: