Exercise for Ovarian and Endometrial Cancer Patients

Overseen By Christina Dieli-Conwright, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Carboplatin, Paclitaxel

Disqualifiers: Musculoskeletal, Neurological, Cardiorespiratory, 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: Unknown

Duration: 16 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 16-week program of aerobic and resistance exercise can improve leg function and reduce numbness or tingling in the hands and feet for patients with ovarian or endometrial cancer. It also seeks to determine if this exercise affects inflammation levels in the blood. Participants will either join the exercise program or follow a home-based stretching routine. The trial seeks individuals diagnosed with stage III-IV ovarian or endometrial cancer who are currently receiving chemotherapy after surgery and have a doctor's clearance for moderate to vigorous exercise. As an unphased trial, this study provides a unique opportunity to contribute to understanding the benefits of exercise for cancer patients.

Will I have to stop taking my current medications?

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

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

Research shows that exercise is generally safe and well-tolerated for cancer patients. Studies have found that exercise offers many benefits, such as reducing pain and boosting energy and strength. It can also enhance the quality of life for those with ovarian and endometrial cancer.

For example, one study found that exercise, along with dietary changes, led to better health for ovarian cancer patients. Another study suggested that physical activity might help prevent endometrial cancer and improve the health of cancer survivors.

Overall, exercise appears to be a safe option for cancer patients. It helps manage symptoms and improve well-being, making it a promising part of cancer care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise as a treatment for ovarian and endometrial cancer patients because it offers a non-invasive way to potentially improve health outcomes. Unlike traditional treatments such as surgery, chemotherapy, or radiation, exercise involves aerobic and resistance activities that can be integrated into daily life. This approach not only aims to enhance physical fitness but also boosts overall well-being, which can be empowering for patients during their recovery journey. Plus, exercise has minimal side effects compared to conventional cancer treatments, making it an attractive complementary option.

What evidence suggests that this exercise program is effective for ovarian and endometrial cancer patients?

Research shows that exercise, which participants in this trial may receive, can benefit women with ovarian and endometrial cancer. Studies suggest that exercise may boost physical fitness, muscle strength, and flexibility. It also links to less pain, more energy, and a better quality of life for cancer patients. Some research indicates that exercise might even improve treatment results, such as reducing chemotherapy side effects. Overall, exercise could help cancer patients feel better and get stronger during and after treatment. Meanwhile, another group in this trial will receive attention control, involving home-based stretching, to compare the effects. ^{2 4 5 6 7}

Who Is on the Research Team?

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage III-IV ovarian or endometrial cancer who are starting first-line chemotherapy after surgery. They must be cleared by a doctor to do moderate-vigorous exercise, understand English, and consent to the study and blood draws. It's not for those with certain pre-existing conditions or uncontrolled illnesses that could affect participation.

Inclusion Criteria

Willing to undergo two venous blood draws for the study

I have stage III-IV ovarian or endometrial cancer and am starting chemotherapy with carboplatin and paclitaxel after surgery.

Able to read, write, and understand English

Exclusion Criteria

I do not have any uncontrolled illnesses as determined by my oncologist.

Participants with psychiatric illness/social situations that would limit compliance with study requirements, as determined by the treating oncologist

I have had chemotherapy for cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 16-week virtually supervised aerobic and resistance exercise program or home-based stretching

16 weeks

Virtually supervised sessions via Zoom

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• Exercise

Trial Overview The study tests if a 16-week virtual exercise program can help patients on chemotherapy improve leg function, reduce numbness in hands/feet from chemo (CIPN), and lower inflammation markers in the blood. Participants will either receive this exercise regimen or be part of an attention control group.

How Is the Trial Designed?

Group I: Exercise Experimental Treatment 1 Intervention

Participants randomized to one of two groups with 2:1 ratio: exercise (n=20) \- Aerobic and Resistance Exercise for 16 weeks

Group II: Attention Control Active Control 1 Intervention

Participants randomized to one of two groups with attention control (n=10). -Attention Control for 16 weeks home-based stretching

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

In a study of 393 African American women with invasive epithelial ovarian cancer and 611 controls, predominantly mild intensity recreational physical activity (RPA) was found to significantly reduce the risk of ovarian cancer for those engaging in more than 297 MET-min/week, with an odds ratio of 0.52.

Conversely, predominantly moderate intensity RPA was associated with an increased risk of ovarian cancer for women exceeding 540 MET-min/week, suggesting that the intensity of physical activity may have different effects on cancer risk, particularly in obese women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recreational physical activity and ovarian cancer risk in African American women. Abbott, SE., Bandera, EV., Qin, B., et al.[2022]

The ECHO trial is a phase III randomized controlled trial involving 500 women with newly diagnosed ovarian cancer, aiming to assess the impact of a structured exercise program on progression-free survival and physical well-being during first-line chemotherapy.

Participants in the exercise group will engage in 150 minutes of moderate-intensity exercise weekly, with outcomes including not only cancer progression but also quality of life, fatigue, and overall health, highlighting the potential benefits of exercise in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise during CHemotherapy for Ovarian cancer (ECHO) trial: design and implementation of a randomised controlled trial. Hayes, S., Obermair, A., Mileshkin, L., et al.[2023]

A 26-week home-based exercise program requiring 225 minutes of physical activity per week was found to be feasible and acceptable for women with ovarian cancer, with 80% of participants successfully completing the program.

Participants, including those undergoing chemotherapy, showed significant improvements in physical activity levels, with an increase of 1,593 average steps per day and 15 additional minutes of moderate-intensity activity, all without any adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study. Zhang, X., McClean, D., Ko, E., et al.[2018]

Exercise interventions for women during or after treatment for gynaecological cancer show significant improvements in physical outcomes such as aerobic capacity, muscular strength, and agility, based on a review of 11 studies including randomized controlled trials and cohort studies.

There was no evidence that exercise worsened any outcomes, suggesting that exercise is a safe and beneficial intervention for this population, although the effects on quality of life and other measures were inconsistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of exercise interventions for women during and after gynaecological cancer treatment - a systematic scoping review. Rose, GL., Stewart, EM., Clifford, BK., et al.[2023]

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]

Ovarian cancer survivors often experience treatment-related symptoms and comorbidities that negatively impact their physical health, including high rates of overweight and obesity, malnutrition, and low muscle density, which can lead to worse survival outcomes.

There is a significant need for tailored physical activity and exercise interventions for ovarian cancer survivors, as many are insufficiently active or sedentary, but current knowledge gaps hinder the development of specific exercise guidelines for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Physiological Profile of Ovarian Cancer Survivors to Inform Tailored Exercise Interventions and the Development of Exercise Oncology Guidelines. Schofield, C., Newton, RU., Galvão, DA., et al.[2018]

Nearly 40% of women with ovarian cancer reduced their physical activity in the first year after diagnosis, and about 25% continued to have lower activity levels even 2-4 years later.

Higher levels of physical activity after diagnosis were linked to lower depression scores and better quality of life, suggesting that maintaining or increasing activity may positively impact psychosocial health in ovarian cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in women with ovarian cancer and its association with decreased distress and improved quality of life. Beesley, VL., Price, MA., Butow, PN., et al.[2015]

A six-month aerobic exercise program helped ovarian cancer survivors maintain their weight, while those in the control group gained weight, suggesting that exercise may be beneficial for weight management in this population.

However, the study did not find significant changes in body fat percentage, bone mineral density, or lean body mass, indicating that more precise measurement methods may be needed to assess body composition changes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercise on body composition among women with ovarian cancer. Cao, A., Cartmel, B., Li, FY., et al.[2023]

After surgery for endometrial and ovarian cancer, patients showed only a slight increase in physical activity over four months, averaging just 14 minutes of moderate-to-vigorous activity per week, which is far below the recommended 150 minutes.

Better self-rated health was linked to higher physical activity levels in endometrial cancer survivors, indicating that health perceptions may influence activity, but overall, patients remained insufficiently active, highlighting the need for targeted health promotion interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of post-surgical physical activity in endometrial and ovarian cancer patients. Gorzelitz, J., Costanzo, ES., Spencer, RJ., et al.[2020]

Engaging in at least 2 hours of moderate physical activity per week significantly reduces the risk of ovarian cancer, according to a meta-analysis of 34 studies.

Prolonged sitting time is associated with an increased risk of ovarian cancer, highlighting the importance of reducing sedentary behavior alongside regular physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, sitting time, and the risk of ovarian cancer: A brief research report employing a meta-analysis of existing. Lee, J.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10191940/

Efficacy of exercise interventions for women during and after ... Preliminary research into the role of exercise post-gynaecological cancer suggests an improvement in exercise capacity, muscular strength, and agility.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X25009752

Effects of a combined exercise and dietary intervention on ... A combined exercise and dietary intervention could improve clinical outcomes in patients with ovarian cancer.

3. ovarianresearch.biomedcentral.com ovarianresearch.biomedcentral.com/articles/10.1186/s13048-025-01725-z

Molecular, cellular, biochemical, and rehabilitative insights ... This review paper investigated existing literature on the relationship between physical activity, exercise, and gynecological cancers

4. ocrahope.org ocrahope.org/news/exercise-and-ovarian-cancer/

Exercise and Ovarian Cancer Exercise is linked to many benefits for cancer patients, including decreased pain and increased energy and strength, as well as increasing quality of life.

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

Feasibility and Effectiveness of the Exercise Program in ... The program resulted in significantly improved quality of life, weight and physical fitness of patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3035989/

Recreational Physical Activity and Ovarian Cancer Risk and ... Our data provide weak evidence in support of beneficial effects of physical activity on ovarian cancer risk and survival.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4883806/

Lifestyle changes and the risk of developing endometrial ... Physical activity has only modest effects on EC prevention, but it improved health and QoL in EC and EOC survivors. For EC, exercise may also be a means to ...