Exercise Program for Endometrial Cancer Survivors

Overseen By Jess Gorzelitz, PHD, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Jess S. Gorzelitz

Must not be taking: GLP-1 agonists, Hormone therapy

Disqualifiers: Heart disease, Type 1 diabetes, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 12-week home-based exercise program can enhance fitness and heart health in women who have completed treatment for non-metastatic endometrial cancer and are currently in remission. Participants will follow an exercise routine and receive weekly online health coaching. Women who finished their cancer treatment within the last five years and are not currently experiencing heart issues or using tobacco might be suitable candidates. Participants will receive tools like resistance bands, a dumbbell, and a Fitbit to support their exercise journey. Each participant will earn $50 for each of their two in-person visits. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve recovery and quality of life for other women in remission.

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using semaglutide (a type of diabetes medication) or have used hormone replacement therapy in the last 3 months.

What prior data suggests that this exercise program is safe for endometrial cancer survivors?

Research has shown that home-based exercise programs can be safe for endometrial cancer survivors. For example, one study of a similar 12-week exercise and nutrition program found that participants did well without major problems, suggesting these routines are generally manageable.

Another study found that strength training at home is not only feasible but also enjoyable for those who have had endometrial cancer. Participants were able to stick with the exercises and had a positive experience.

These findings suggest that a 12-week home-based exercise program is likely safe for participants, with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 12-week home-based exercise program for endometrial cancer survivors because it offers a unique, accessible approach to improving health outcomes. Unlike standard care options, which often focus on surgery, radiation, or chemotherapy, this intervention empowers survivors to engage in regular physical activity from the comfort of their homes. The program includes weekly online health coaching, providing personalized support and motivation, which is not typically part of conventional treatments. This innovative approach could enhance quality of life and potentially reduce cancer recurrence risk, making it a promising complement to traditional therapies.

What evidence suggests that this exercise program is effective for endometrial cancer survivors?

Studies have shown that exercise can greatly benefit endometrial cancer survivors. Regular physical activity is associated with a 46% lower risk of cancer recurrence and a 67% increase in cancer-free survival time. In this trial, participants will join a 12-week home-based exercise program. This program has proven practical and well-received, with high satisfaction and no adverse effects. Previous research on similar programs demonstrated improvements in fitness and health among participants. This evidence suggests that the 12-week exercise program could enhance fitness and heart health for endometrial cancer survivors. ^{1 3 4 6 7}

Who Is on the Research Team?

Jess Gorzelitz, PHD, MS

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

The STRIVE Cardio trial is for English-speaking women aged 18-74 who have been treated for non-metastatic Type I endometrial cancer stages I-IIIc within the last five years and are now in remission. They must be able to use technology for telecoaching, pass a physical activity readiness test, get medical clearance if needed, and commit to the study's duration.

Inclusion Criteria

My doctor has cleared me to participate in this trial.

I am fluent in both spoken and written English.

I am willing and able to sign a consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Pre-Intervention

Participants wear an accelerometer for one week prior to the exercise intervention

1 week

Exercise Intervention

Participants engage in a 12-week distance-based exercise program with virtual health coaching and in-person pre- and post-intervention measures

12 weeks

2 visits (in-person), weekly virtual coaching sessions

Follow-up

Participants are monitored for changes in vascular structure and function, and other health metrics post-intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• 12-week home-based exercise intervention

Trial Overview This study tests a 12-week home-based exercise program designed to improve fitness and heart health in endometrial cancer survivors. Participants will receive resistance bands, a dumbbell, and a Fitbit. Their fitness levels and cardiovascular health will be assessed before and after the intervention.

How Is the Trial Designed?

Group I: 12-week Exercise Intervention Experimental Treatment 1 Intervention

In this single-arm study, every participant will be enrolled in the 12-week distance-based exercise intervention. All participants will receive an exercise regimen and the necessary materials to complete and measure their exercise. All participants will receive weekly online heath coaching.

12-week home-based exercise intervention is already approved in United States for the following indications:

Approved in United States as Exercise Intervention for:

• Improvement of functional fitness and cardiovascular health in endometrial cancer survivors

Who Is Running the Clinical Trial?

Jess S. Gorzelitz

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

A six-month home-based exercise intervention for 100 endometrial cancer survivors led to significant improvements in sexual function, with 43% of participants reporting better sexual function after the program.

Increased weekly physical activity was linked to a 6.5% higher likelihood of improved sexual interest, suggesting that physical activity may be an effective strategy to enhance sexual health in endometrial cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual health of endometrial cancer survivors before and after a physical activity intervention: A retrospective cohort analysis. Armbruster, SD., Song, J., Bradford, A., et al.[2018]

Only 14.2% of endometrial cancer patients were found to be suitable for unsupervised exercise programs based on their health status at diagnosis, which increased to 20.5% when excluding common comorbidities like hypertension and diabetes.

The study indicates that a significant majority (approximately 80%) of endometrial cancer patients may require referral to medically-supervised exercise programs due to health issues that could hinder their ability to safely engage in unsupervised exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prescription or proscription of exercise in endometrial cancer care. Zhang, X., Haggerty, AF., Brown, JC., et al.[2018]

An individualized exercise program for endometrial cancer patients, starting six weeks post-surgery, showed high feasibility with 41% consent rate and 86% attendance, and no adverse events reported.

Participants experienced significant improvements in quality of life, including emotional and cognitive functioning, as well as reductions in visceral fat and increased physical fitness, with maximum weight loss of 8.4 kg after six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Effectiveness of the Exercise Program in Endometrial Cancer; Feasibility and Acceptability Survivorship Trial (EPEC-FAST). Smits, A., Galaal, K., Winnan, S., et al.[2023]

A 6-month lifestyle intervention program for obese endometrial cancer survivors led to a significant weight loss of 3.5 kg, while the control group experienced a weight gain of 1.4 kg, demonstrating the program's efficacy in promoting weight management.

Participants in the intervention group also showed a notable increase in physical activity, as measured by the Leisure Score Index, with an improvement of 16.4 compared to a decline in the control group, indicating positive changes in lifestyle behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effectiveness of a lifestyle intervention program in obese endometrial cancer patients: a randomized trial. von Gruenigen, VE., Courneya, KS., Gibbons, HE., et al.[2008]

A home-based muscle strengthening program for endometrial cancer survivors was found to be feasible, with 75% of participants adhering to the twice-weekly exercise schedule over 10 weeks and high satisfaction reported.

The program was safe, with no injuries or adverse events reported, indicating that such interventions can be effectively implemented for cancer survivors to promote physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of home-based strength training in endometrial cancer survivors. Gorzelitz, J., Costanzo, E., Gangnon, R., et al.[2023]

In a study of 386 endometrial cancer survivors, those who met public health exercise guidelines and maintained a healthy body weight reported significantly better quality of life (QoL) compared to those who did not, highlighting the importance of physical activity and weight management.

Both exercise and body mass index (BMI) were found to be independently associated with QoL, suggesting that interventions aimed at increasing exercise and reducing excess weight could improve the well-being of endometrial cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations among exercise, body weight, and quality of life in a population-based sample of endometrial cancer survivors. Courneya, KS., Karvinen, KH., Campbell, KL., et al.[2006]

A 12-week physical activity intervention for obese endometrial cancer survivors showed significant improvements in physical function, waist circumference, and quality of life, with large effect sizes compared to a control group.

Despite low recruitment rates, the intervention was feasible, with a majority of participants attending most sessions and reporting increased physical activity, indicating potential for further research in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a physical activity intervention for obese, socioculturally diverse endometrial cancer survivors. Rossi, A., Garber, CE., Ortiz, M., et al.[2017]

The 12-week home-based aerobic exercise and nutrition counseling program for obese endometrial cancer survivors showed a high adherence rate of 83.3%, indicating that such interventions can be feasible for this population.

Participants experienced significant reductions in fat mass and BMI, along with improved immune response as indicated by increased T-cell activity, although there were no significant changes in cardiorespiratory fitness or cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Home-Based Exercise and Personalized Nutrition Counseling Intervention in Endometrial Cancer Survivors. Schwartz, AR., Bartlett, DB., Johnson, JL., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8232933/

A Pilot Study of Home-Based Exercise and Personalized ... A longitudinal pilot study assessed a 12-week home-based aerobic exercise and nutrition counseling intervention in obese endometrial cancer survivors.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02575872

NCT02575872 | Physical Activity Behavioral Intervention in ... To determine the effects of a 12-week behavior/exercise intervention on body composition among ethnically diverse endometrial cancer survivors. TERTIARY ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352578923003302

Perceptions of a comprehensive physical activity behavior ... Regular participation in physical activity has been shown to reduce endometrial cancer recurrence by 46 % and increase disease-free survival by 67 % ( ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9362896/

Feasibility and acceptability of home-based strength training ... Home-based strength training was feasible in endometrial cancer survivors, with high adherence to the program, no adverse events, and highly rated satisfaction.

5. rgangnon.org rgangnon.org/publication/gorzelitz-2021/gorzelitz-2021.pdf

Feasibility and acceptability of home-based strength training ... The purpose of this study was to determine the feasibility of home-based muscle strengthening activity in endometrial cancer survivors. Methods ...

6. researchgate.net researchgate.net/publication/352321089_A_Pilot_Study_of_Home-Based_Exercise_and_Personalized_Nutrition_Counseling_Intervention_in_Endometrial_Cancer_Survivors

(PDF) A Pilot Study of Home-Based Exercise and ... Methods A longitudinal pilot study assessed a 12-week home-based aerobic exercise and nutrition counseling intervention in obese endometrial ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04262180

Physical Activity Promotion for Breast and Endometrial ... The purpose of this study is test an adaptive physical activity intervention approach that reserves the most resources and support for women who do not fare ...