Clinical trial NCT05664178: Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology
Official title: Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology (Remote REPS - GI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Gastrointestinal Cancer
Keywords: Gastrointestinal Cancer
Remote Resistance Exercise
GI Cancer Stage III
GI Cancer Stage IV
Tele-Resistance Training
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-12-23
Enrollment: 100
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: The purpose of the study is to evaluate a tele-resistance training exercise program for individuals undergoing chemotherapy for advanced upper gastrointestinal cancer.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants that Enroll and Consent - Enrollment Feasibility
timeFrame: Up to 36 Months
measure: Percentage of Participants that Complete Study Assessments - Retention Feasibility
timeFrame: Up to 3 Months
measure: Exercise Adherence - Feasibility
timeFrame: Up to 6 Months
measure: Participant Evaluation of Feasibility and Acceptability - Acceptability
timeFrame: Up to 6 Months
measure: Participant Self-Reported Musculoskeletal Injuries - Safety
timeFrame: Up to 6 Months
measure: Participant Muscular Strength - Baseline
timeFrame: At Baseline
measure: Participant Muscular Strength - Follow-up
timeFrame: Up to 6 Months
measure: Participant Muscular Endurance - Baseline
timeFrame: At Baseline
measure: Participant Muscular Endurance - Follow-up
timeFrame: Up to 6 Months
measure: Participant Skeletal Muscle Index (SMI) - Baseline
timeFrame: At Baseline
measure: Participant Skeletal Muscle Index (SMI) - Follow-up
timeFrame: Up to 6 Months
measure: Participant Skeletal Muscle Density (SMD) - Baseline
timeFrame: At Baseline
measure: Participant Skeletal Muscle Density (SMD) - Follow-up
timeFrame: Up to 6 Months
measure: Participants Health-Related Quality of Life
timeFrame: Up to 6 Months
measure: Participant Fatigue
timeFrame: Up to 6 Months
measure: Participant Physical Functioning
timeFrame: Up to 6 Months
measure: Participant Chemotherapy-induced peripheral neuropathy (CIPN)
timeFrame: Up to 6 Months
measure: Participant Self Reported Exercise - Baseline
timeFrame: At Baseline
measure: Participant Self Reported Exercise - Follow-up
timeFrame: Up to 6 Months
measure: Participant Clinicodemographic Characteristics - Baseline
timeFrame: At Baseline
measure: Participant Clinicodemographic Characteristics - Follow-up
timeFrame: Up to 6 Months
measure: Participant Treatment Outcome
timeFrame: Up to 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Nathan Parker, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: