NCT07596732

Brief Summary

This study will evaluate whether a remotely delivered exercise program can improve chemotherapy tolerability in patients with gastrointestinal or lung cancer receiving chemotherapy. In this decentralized, digital randomized clinical trial, up to 120 adults with gastrointestinal or lung cancer will be randomized to either a home-based aerobic and resistance exercise program or home-based progressive stretching program. All study activities will be conducted remotely using digital technologies and home-based assessments. Participants in both groups will receive Bluetooth-enabled wearable devices for monitoring physical activity, body weight, blood pressure, and other health measures. The primary objective is to determine whether exercise improves chemotherapy relative dose intensity compared with stretching. The intervention will continue throughout chemotherapy treatment or for up to 32 weeks.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chemotherapy Relative Dose Intensity

    The ratio of the delivered dose intensity to the standard or planned dose intensity.

    Up to 32 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

The exercise group will engage in aerobic and muscle-strengthening activities.

Behavioral: Exercise

Stretching

ACTIVE COMPARATOR

The stretching group will engage in whole-body static stretching activities.

Behavioral: Stretching

Interventions

ExerciseBEHAVIORAL

The exercise group will be provided with Bluetooth-enabled devices and home exercise equipment. Participants will meet with an exercise trainer weekly to learn how to engage in the exercise program.

Exercise
StretchingBEHAVIORAL

The stretching group will be provided with Bluetooth-enabled devices. Participants will meet with an exercise trainer weekly to learn how to engage in the stretching program.

Stretching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gastrointestinal cancer (esophageal, gastric, pancreatic, colon, and rectal) treated with chemotherapy (and other treatments, as clinically indicated) before surgery OR Lung cancer (non-small cell and small-cell) treated with chemotherapy (and other treatments, as clinically indicated) for advanced- or extensive-stage disease.
  • Completion of the modified version of the Physical Activity Readiness Questionnaire.

You may not qualify if:

  • Actively treated for another non-gastrointestinal or non-lung malignancy (surveillance with observation is allowed).
  • Engage in more than 150 minutes per week of aerobic physical activity and two or more sessions of muscle strengthening activity per week over the last three months (self-report).
  • Unable to walk for 6 minutes or two city blocks independently (self-report).
  • Enrollment in another study that intervenes upon physical activity, diet, or body composition as a primary objective (self-report).
  • Unable to read and speak English.
  • No access to a reliable internet connection.
  • Currently an AdventHealth employee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach NeoplasmsDiseaseEsophageal NeoplasmsPancreatic NeoplasmsColonic NeoplasmsRectal NeoplasmsLung Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHead and Neck NeoplasmsEsophageal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesColorectal NeoplasmsIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Justin Brown, Ph.D.

    AdventHealth

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Exercise & Cancer Biology Research Program

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 19, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share