Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology

Phase 1

Recruiting

• Conditions: Gastrointestinal Cancer

• Registration Number: NCT05664178
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

The purpose of the study is to evaluate a tele-resistance training exercise program for individuals undergoing chemotherapy for advanced upper gastrointestinal cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-23
• Study Start: 2023-02-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-05-30
• Primary Completion: 2026-08-22
• Study Completion: 2026-08-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age ≥ 18 years
• Biopsy-proven upper GI cancer, stage III-IV
• ECOG performance status 0-1
• Treatment plan of chemotherapy with planned return to Moffitt Cancer Center for restaging
• Able to read and speak English fluently
• Capable of providing informed consent

Exclusion Criteria

• Regular engagement in RT (2x/week targeting all major muscle groups)
• Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and Patient-Reported Measurement Information System (PROMIS) screening questions
• Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV).
• Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT
• Numeric pain rating scale of ≥ 7 out of 10
• Myopathic or rheumatologic disease that impacts physical function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants that Enroll and Consent - Enrollment Feasibility	Up to 36 Months	Enrollment will be considered feasible if ≥ 70% of eligible and approached patients actually consent and enroll
Participant Muscular Strength - Baseline	At Baseline	Muscular strength will be measured using four separate 1-repetition maximum (1RM) lifts: chest press, seated row, leg press, and leg extension performed on resistance training machines. If a particular 1RM lift is contraindicated for a given participant (e.g., limited range of motion for a given joint or osteoporosis), the lift will be skipped, or 5-repetition maximum (5RM) will be measured instead of 1RM, and 1RM will be estimated from 5RM.
Participant Clinicodemographic Characteristics - Follow-up	Up to 6 Months	Participant clinicodemographic characteristics including tumor type and cancer stage, chemotherapy type, sex, age, body mass index, race/ethnicity, and marital status will be collected from participants' electronic medical records.
Exercise Adherence - Feasibility	Up to 6 Months	Exercise adherence will be assessed based on performance of prescribed exercise volume, with tele-RT volumes considered feasible if participants perform ≥ 70% of the volume prescribed.
Participant Self-Reported Musculoskeletal Injuries - Safety	Up to 6 Months	Participants will be asked to report the following information: type (joint or soft tissue or other), location (specific body part), and cause (description of activity during which injury was incurred). Participants will then rate the injury on a scale of 1-4 (1=not related, 2=unlikely related, 3=likely related, 4=definitely related). The severity of the injury will be rated on a scale of 1-4 (1=mild/no change in daily activity, 2=some limitation of daily activity, 3=major limitation of daily activity, 4=life threatening). The duration for which daily activities were impacted will be rated on a scale from 1-5 (1=no change, 2=1-3 days, 3=4-7 days, 4=1-2 weeks, 5=more than 2 weeks). The numerator of the variable used to determine program safety will be the number of musculoskeletal injuries that were rated at least a 3 for relatedness to RT (likely related or definitely related) and caused at least some limitation of daily activity lasting more than 3 days.
Participant Muscular Endurance - Follow-up	Up to 6 Months	Muscular endurance will be measured by the maximum number of repetitions a participant can perform at 70% of the baseline 1-repetition maximum (1RM) for the same four lifts
Participant Skeletal Muscle Index (SMI) - Baseline	At Baseline	Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Participant Skeletal Muscle Index (SMI) - Follow-up	Up to 6 Months	Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Participant Skeletal Muscle Density (SMD) - Follow-up	Up to 6 Months	Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Participant Muscular Strength - Follow-up	Up to 6 Months	Muscular strength will be measured using four separate 1-repetition maximum (1RM) lifts: chest press, seated row, leg press, and leg extension performed on resistance training machines. If a particular 1RM lift is contraindicated for a given participant (e.g., limited range of motion for a given joint or osteoporosis), the lift will be skipped, or 5-repetition maximum (5RM) will be measured instead of 1RM, and 1RM will be estimated from 5RM.
Participant Self Reported Exercise - Baseline	At Baseline	Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Participant Self Reported Exercise - Follow-up	Up to 6 Months	Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Participant Treatment Outcome	Up to 6 Months	Participant relevant treatment outcomes including chemotherapy dose reductions and changes in chemotherapy will be collected from participants' electronic medical records.
Percentage of Participants that Complete Study Assessments - Retention Feasibility	Up to 3 Months	Retention will be considered feasible if ≥ 70% of participants who complete baseline measures also complete followup measures
Participant Skeletal Muscle Density (SMD) - Baseline	At Baseline	Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Participants Health-Related Quality of Life	Up to 6 Months	Health-related quality of life will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G)
Participant Fatigue	Up to 6 Months	Participant fatigue will be measured using the FACT-Fatigue questionnaire (FACT-F)
Participant Chemotherapy-induced peripheral neuropathy (CIPN)	Up to 6 Months	Participant CIPN will be measured using the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)
Participant Evaluation of Feasibility and Acceptability - Acceptability	Up to 6 Months	Participants evaluation of feasibility and acceptability will be assessed with a questionnaire, adapted to fit the intervention. The questionnaire includes both Likert Scale and open-ended questions. An item-by-item basis and as average item score, with scores ≥4 ("agree" to "strongly agree") indicating acceptability. Open-ended responses will be analyzed qualitatively to inform intervention improvement.
Participant Muscular Endurance - Baseline	At Baseline	Muscular endurance will be measured by the maximum number of repetitions a participant can perform at 70% of the baseline 1-repetition maximum (1RM) for the same four lifts
Participant Physical Functioning	Up to 6 Months	Participants physical functioning will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form
Participant Clinicodemographic Characteristics - Baseline	At Baseline	Participant clinicodemographic characteristics including tumor type and cancer stage, chemotherapy type, sex, age, body mass index, race/ethnicity, and marital status will be collected from participants' electronic medical records.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States