Physical Activity Program for Endometrial Cancer Survivors

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Unmanaged lymphedema, Recurrent disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a home-based exercise program can help endometrial cancer survivors lose weight. Participants will follow a plan that includes either aerobic exercises (cardiovascular exercise) or a combination of aerobic and resistance exercises (strength training). The trial seeks women who have had Stage I-II endometrial cancer, completed treatment 6 to 36 months ago, and have a body mass index (BMI) between 30 and less than 45. Participants should be comfortable using a phone and a computer or similar device for coaching and monitoring. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance post-treatment care for endometrial cancer survivors.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

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

A previous study found home-based strength training practical and safe for women who have survived endometrial cancer. Research has shown that exercise, including walking and other aerobic activities, links to better quality of life and improved daily functioning for cancer survivors. Another study confirmed the safety of walking and aerobic exercises for endometrial cancer patients.

Resistance training also appears safe. Studies have shown that performing resistance exercises at home can enhance strength and agility without major safety concerns. Overall, these exercises are generally well-tolerated and considered safe for endometrial cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how structured physical activity programs can benefit endometrial cancer survivors. Unlike standard care options that primarily focus on medical follow-ups and self-help materials, this trial introduces personalized exercise plans that include aerobic exercise and resistance training. The use of technology, such as accelerometers and video chats via iPads, allows for real-time monitoring and support, making it easier for participants to stay on track. This approach could provide insights into how regular physical activity impacts quality of life, fitness levels, and dietary habits, potentially leading to more holistic post-treatment care for cancer survivors.

What evidence suggests that this trial's physical activity programs could be effective for endometrial cancer survivors?

Research shows that physical activity, especially aerobic exercise like walking or cycling, can lower the risk of endometrial cancer by 15-53% in highly active individuals. Studies also find that endometrial cancer survivors who exercise regularly tend to live longer and enjoy a better quality of life. Aerobic exercise enhances heart health, which is crucial for overall well-being.

In this trial, participants in the NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART) arm will engage in both aerobic and resistance training exercises. Resistance training, such as lifting weights or using resistance bands, benefits endometrial cancer survivors. Research indicates that muscle-strengthening exercises at home are feasible and can boost exercise capacity, muscle strength, and flexibility. Participants in the NEXT-Steps- Aerobic Exercise (NS-A) arm will focus solely on aerobic exercise. Both aerobic and resistance exercises can aid in weight loss and improve health for cancer survivors. Overall, exercise is vital for enhancing life quality and health outcomes for those who have survived endometrial cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for Stage I-II endometrial cancer survivors with a BMI of 30-<45, who are 6-36 months post-treatment, over 18 years old, and have access to a phone and internet. Participants must be able to visit the campus twice, speak English, consent to the study, and not be doing much exercise or in another weight loss program.

Inclusion Criteria

Your body mass index (BMI) is between 30 and less than 45 kg/m2.

Diagnosed with Stage I-II endometrial cancer

Six to 36 months post treatment

Exclusion Criteria

You have medical conditions that make it unsafe for you to do exercise at home or follow a low-fat, high fruit and vegetable diet.

Functional limitations requiring a walker/scooter/wheelchair for daily activities

You participate in strength training exercises for at least 30 minutes, on 2 or more days every week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete questionnaires, physical assessments, and provide blood samples

1 week

1 visit (in-person)

Treatment

Participants follow a home-based physical activity program with or without resistance training

6 months

Monthly calls (virtual), ongoing self-monitoring

Midpoint Assessment

Participants complete online questionnaires about physical activity, safety, and quality of life

3 months

Online

Follow-up

Participants are monitored for changes in lean body mass and overall satisfaction with the program

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise
• Resistance Training

Trial Overview The study tests if a home-based physical activity program can help these survivors lose weight. It includes using an accelerometer (like Fitbit), answering questionnaires, resistance training through video chats, fitness testing, and receiving telephone coaching.

How Is the Trial Designed?

Group I: NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART) Experimental Treatment 6 Interventions

Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit. Participants placed into an exercise plan focused on physical activity and resistance training. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals. Participants receive resistance bands to perform resistance exercises. Exercise handouts and an iPad mini with training videos used to video chat with a research team member. Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.

Group II: NEXT-Steps- Aerobic Exercise (NS-A) Experimental Treatment 5 Interventions

Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit. Participants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals. Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.

Group III: Standard Care Control Group (CG) Active Control 4 Interventions

Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit. Participants receive standard of care consisting of phone calls asking about their health and self-help materials. Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

In a study of 425 endometrial cancer survivors over a median follow-up of 14.5 years, higher levels of recreational physical activity after diagnosis were strongly linked to improved overall and disease-free survival, with hazard ratios of 0.33 for both outcomes.

Maintaining high levels of recreational physical activity from before to after diagnosis also correlated with better survival rates, indicating that consistent physical activity may play a crucial role in enhancing outcomes for endometrial cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Cohort Study of Pre- and Postdiagnosis Physical Activity and Endometrial Cancer Survival. Friedenreich, CM., Cook, LS., Wang, Q., et al.[2021]

A 10-week home-based strength training program for 40 post-treatment endometrial cancer survivors resulted in significant improvements in physical function, particularly in chair sit-to-stand, arm curls, and mobility tests.

Despite these functional gains, there were no significant changes in body composition or blood biomarkers, indicating that strength training can enhance physical capabilities without necessarily affecting weight or metabolic markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in strength and agility measures of functional fitness following a telehealth-delivered home-based exercise intervention in endometrial cancer survivors. Gorzelitz, JS., Stoller, S., Costanzo, E., et al.[2023]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9688636/

Feasibility and Effectiveness of the Exercise Program in ... We showed that our individualized one-to-one exercise intervention in endometrial cancer patients is feasible in terms of patient recruitment, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7613481/

Quantifying the Effect of Physical Activity on Endometrial ... Eight studies found significant reductions in disease risk of 15-53%, but only in the mostphysically active individuals. Physical activity reduces endometrial ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.20.01336

Prospective Cohort Study of Pre- and Postdiagnosis ... Conclusion. Recreational physical activity, especially postdiagnosis, is associated with improved survival in survivors of endometrial cancer.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24031888

Review Article Effect of Physical Activity on Quality of Life ... The results suggest that increased PA among EC survivors can contribute to better QoL. Only 2 of the 7 studies identified were intervention studies, suggesting ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06534008

Strive Cardio for Endometrial Cancer Survivors The Effect of Combined Aerobic and Muscle Strengthening Exercises on Structural and Functional Cardiovascular Adaptations in Endometrial Cancer Survivors.

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

Feasibility and acceptability of home-based strength training ... This study shows that a home-based muscle strengthening exercise is feasible in endometrial cancer survivors.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352578924002388

Attitudes, beliefs and preferences surrounding home ... Exercise and physical activity are associated with reduced risk of death, higher quality of life and better functioning in cancer survivors including ...

8. jacc.org jacc.org/doi/10.1016/j.jaccao.2024.09.013

Changes in Physical Activity and Cardiovascular Disease ... Our findings indicate that staying physically activity after a cancer diagnosis is linked to a reduced risk for MI and HF, underscoring the ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03722030

NCT03722030 | Telehealth-Based Resistance Training ... Other interventions have demonstrated that walking and aerobic exercise are safe and feasible in endometrial cancer patients. However few published studies ...