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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Patients currently taking weight loss drugs.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Interrupted Sedentary Time Intervention

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Interrupted Sedentary Time InterventionExperimental treatment 1 intervention
Group B: Usual Care Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Intervention Completion Rate (Feasibility)

Intervention feasibility is defined as: 1) A participant completes ≥70% of the supervised activity breaks on at least 3 out of the 4 infusion appointments. 2) A participant completes ≥70% of the prescribed home-based resistance activity breaks on at least 48 days out of the possible 68 days (12 week) intervention (excluding the 4 infusion days and 1 rest day per week) (i.e., meet interrupting sedentary behavior goals across at least 70% of the intervention). 3) A participant completes ≥70% of the prescribed home-based step goals (i.e., \>250 steps per hour) on at least 48 days out of the possible 68 days (12 week) intervention (excluding the 4 infusion days and 1 rest day per week) (i.e., meet interrupting sedentary behavior goals across at least 70% of the intervention).

Time frame
12 weeks
2

Refusal Rate

Defined as ≤50% of eligible screened participants refuse to complete intervention.

Time frame
12 weeks
3

Retention Rate

Retention of consented participants to study end is ≥70%.

Time frame
13 weeks
4

Acceptability of Intervention Measure (AIM) Scale

Assessed by the Acceptability of the Intervention Measures, a 4-item measure rated on a 5-point Likert scale with answers ranging from "Completely disagree" to "Completely agree." A total scores range is 4 to 20 with a higher score indicating greater acceptability. The intervention will be deemed acceptable by participants if ≥70% of participants have a mean score ≥ 4 on the AIM.

Time frame
13 weeks

Secondary outcomes

1

Participant Glucose Level

Glucose levels will be assessed by constant glucose monitoring where an average of \>180 mg/dl will be considered hyperglycemic.

Time frame
Assessed for one week at each timepoint (baseline & post-intervention).
2

Participant Insulin Resistance

Insulin resistance will be assessed by calculating Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from fasting blood samples where values \>1.9 will be considered insulin resistant.

Time frame
Assessed for one week at each timepoint (baseline & post-intervention).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.