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Clinical Trial 21742

Cancer Type: Gastrointestinal Tumor
Study Type: Supportive Care
NCT#: NCT05664178

Phase: N/A
Principal Investigator: Parker, Nathan (Nate)

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

Tele-Resistance Training During Chemotherapy For Advanced Upper Gastrointestinal Cancer

Summary

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

Objective

Specific Aim #1 Evaluate the feasibility (enrollment, retention, and adherence to exercise sessions and prescribed exercise volumes), safety, and acceptability of a 12-week tele-RT intervention during first-line chemotherapy for advanced upper GI cancer. Specific Aim #2 Compare 12-week changes in muscular strength and muscular endurance, skeletal muscle index (SMI) and skeletal muscle density (SMD), quality of life, fatigue, and physical functioning between patients randomized to tele-RT vs. usual care (UC) during first-line chemotherapy for advanced upper GI cancer.

Treatments

Therapies

Medications

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

    • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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