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Tele-Resistance Training for Gastrointestinal Cancer
Phase 1 & 2
Recruiting
Led By Nathan Parker, PhD, MPH
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Biopsy-proven upper GI cancer, stage III-IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial evaluates if exercise can help those with advanced GI cancer during chemotherapy.
Who is the study for?
This trial is for adults over 18 with advanced upper gastrointestinal cancer who are undergoing chemotherapy and can return to Moffitt Cancer Center for check-ups. They should be relatively active (able to care for themselves or do light work) and speak English fluently. People already doing regular resistance training, in severe pain, with recent fractures, muscle diseases, or serious heart/lung conditions cannot join.Check my eligibility
What is being tested?
The study tests a tele-resistance training exercise program designed for patients receiving chemotherapy for advanced upper GI cancers. The goal is to see if exercising from home using remote guidance can benefit these individuals during their treatment.See study design
What are the potential side effects?
Since the intervention involves physical exercise, potential side effects may include muscle soreness, fatigue, and an increased risk of injury if exercises are not performed correctly. However, specific side effects will depend on individual health status.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My upper GI cancer is confirmed by biopsy and is stage III-IV.
Select...
I am fully active or can carry out light work.
Select...
I am scheduled for chemotherapy and will return to Moffitt for cancer reassessment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Exercise Adherence - Feasibility
Participant Chemotherapy-induced peripheral neuropathy (CIPN)
Participant Clinicodemographic Characteristics - Baseline
+19 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Tele-Resistance Training (RT)Experimental Treatment1 Intervention
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.
Group II: Usual Care (UC)Active Control1 Intervention
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.
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Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,392 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,567 Total Patients Enrolled
Nathan Parker, PhD, MPHPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
70 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a muscle or joint disease that affects my ability to move.I am 18 years old or older.My upper GI cancer is confirmed by biopsy and is stage III-IV.I regularly exercise, focusing on all major muscle groups twice a week.I haven't had a recent fracture or injury that stops me from undergoing radiation therapy.I am fully active or can carry out light work.I understand the study and can agree to participate.I am scheduled for chemotherapy and will return to Moffitt for cancer reassessment.I do not have severe heart or lung conditions.My pain level is 7 or higher on a scale of 0 to 10.
Research Study Groups:
This trial has the following groups:- Group 1: Tele-Resistance Training (RT)
- Group 2: Usual Care (UC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current openings for individuals to join this research trial?
"According to clinicaltrials.gov, recruitment for this research is still underway after the initial posting date of December 2nd 2022 and latest update on December 16th 2022."
Answered by AI
How many subjects are involved in this research study?
"Affirmative. Clinicaltrials.gov records that this clinical trial, which was posted on December 2nd 2022, is actively enrolling patients to participate in the study. Researchers need to enlist roughly one hundred individuals from a single medical centre."
Answered by AI
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