Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Gastrointestinal Cancer

Treatments: Behavioral: Tele-Resistance Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05664178

1K22CA262352-01 (U.S. NIH Grant/Contract)

MCC-21742

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Tele-Resistance Training (RT)

Experimental group

Description:

Participants will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week for 12 weeks. Participants will also be encouraged to perform moderate aerobic exercise at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise.

Treatment:

Behavioral: Tele-Resistance Training

Usual Care (UC)

No Intervention group

Description:

Participants randomized to the Usual Care (UC) arm will be provided with information materials outlining resistance training using body weight or basic equipment. Participants will wear a FitBit fitness watch to monitor aerobic exercise.