Tele-Resistance Training for Gastrointestinal Cancer

Overseen By Nathan Parker, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Unstable cardiac, Pulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tele-resistance training program for individuals with advanced upper gastrointestinal cancer undergoing chemotherapy. The researchers aim to determine if exercising from home, with guidance and tracking, can improve strength and fitness during treatment. Participants will be divided into two groups: one will receive usual care with exercise information, while the other will engage in guided resistance training sessions twice a week. This trial suits individuals with stage III or IV upper gastrointestinal cancer who can read and speak English. As a Phase 1 and Phase 2 trial, the research focuses on understanding how the treatment works and measuring its effectiveness in an initial, smaller group.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this tele-resistance training is safe for individuals undergoing chemotherapy?

Research shows that tele-resistance training is generally well-tolerated by people undergoing cancer treatment. Studies have found that this exercise can enhance physical abilities and quality of life without causing major side effects.

For instance, some research suggests that resistance exercises during chemotherapy might help patients maintain their treatment schedule, indicating that their bodies handle both the treatment and exercise well.

Overall, these studies have not reported significant negative effects from tele-resistance training, suggesting the exercise program is safe for patients. However, consulting a doctor before starting any new exercise routine, especially during cancer treatment, remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Tele-Resistance Training for gastrointestinal cancer because it offers a unique approach to support patients beyond traditional treatments like surgery, chemotherapy, and radiation. Unlike these standard treatments, which directly target cancer cells, Tele-Resistance Training empowers patients through guided, remote strength-building exercises. This method not only improves physical strength but also enhances overall well-being and quality of life. By utilizing technology like FitBit watches to monitor progress, this approach makes it easier for patients to stay active and engaged in their own care from the comfort of their homes. Researchers hope this could lead to better recovery outcomes and a more holistic cancer care model.

What evidence suggests that tele-resistance training is effective for gastrointestinal cancer?

Research has shown that tele-resistance training, which participants in this trial may receive, can benefit people with cancer, especially those undergoing chemotherapy. Studies have found that exercise programs like tele-resistance training can enhance physical abilities and muscle strength. Conducted through telehealth, this training can also improve balance and cardiovascular function. One study suggested it might help patients better tolerate chemotherapy. Overall, early evidence is promising for using tele-resistance training to support cancer treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Nathan Parker, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My upper GI cancer is confirmed by biopsy and is stage III-IV.

I am fully active or can carry out light work.

I understand the study and can agree to participate.

Exclusion Criteria

I have a muscle or joint disease that affects my ability to move.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of muscular strength, endurance, and clinicodemographic characteristics

1 week

Treatment

Participants undergo a tele-resistance training exercise program for 12 weeks, including resistance and aerobic exercises

12 weeks

Remote monitoring with FitBit

Follow-up

Participants are monitored for safety, effectiveness, and retention feasibility after treatment

Up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Tele-Resistance Training

Trial Overview 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.

How Is the Trial Designed?

Group I: Tele-Resistance Training (RT) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The ReStOre@Home program, a virtual 12-week rehabilitation intervention for patients who have completed treatment for oesophago-gastric cancer, aims to assess feasibility through recruitment, adherence, and acceptability among 12 participants.

This study will evaluate various outcomes, including physical performance and quality of life, to determine if a remote, multidisciplinary approach can effectively support UGI cancer survivors during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ReStOre@Home: Feasibility study of a virtually delivered 12-week multidisciplinary rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer - study protocol. O'Neill, L., Guinan, E., Brennan, L., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05664178

Remote Resistance Exercise Powering Survivors The purpose of the study is to evaluate a tele-resistance training exercise program for individuals undergoing chemotherapy for advanced upper gastrointestinal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11745508/

Preliminary Effectiveness of a Telehealth-Delivered ... We aimed to evaluate the preliminary effectiveness of a one-on-one, supervised telehealth exercise program on physical function, muscular endurance, balance, ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-11031

Remote Resistance Training (tele-RT) for Patients with ... This clinical trial evaluates a remote telemedicine (tele)-resistance training (RT) exercise program for patients who are undergoing chemotherapy for stage III ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S155171442500268X

TeleHealth resistance exercise intervention to preserve ... Two studies suggested that exercise interventions, particularly those incorporating resistance training during chemotherapy could improve RDI in individuals ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11100177/

Effect of exercise-based cancer rehabilitation via telehealth Meta-analysis indicated that telehealth exercise-based cancer rehabilitation significantly improved cardiorespiratory fitness (SMD = 0.34, 95% ...

6. npcf.us npcf.us/clinical-trials/resistance-training-intervention-to-improve-physical-function-in-patients-with-pancreatic-cancer-receiving-combination-chemotherapy-or-have-undergone-surgery-pancstrength-study/

Resistance Training Intervention To Improve Physical Function In ... Tele-exercise resistance training may improve physical function and quality of life in patients with pancreatic cancer. Detailed Description.