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

Trial Summary

What is the purpose of this trial?

The purpose of this research is to determine whether a 16-week virtually supervised aerobic and resistance exercise program is feasible in patients receiving first-line chemotherapy after surgery for ovarian or endometrial cancer and if it will improve lower extremity function (function of the legs), lessen chemotherapy-induced peripheral neuropathy (CIPN; numbness or tingling in the hands or feet), and if there is any effect on inflammatory blood markers (the level of a certain marker in the blood that is associated with inflammation; redness and swelling).

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 data supports the effectiveness of this treatment for ovarian and endometrial cancer patients?

Research shows that exercise can improve physical well-being and quality of life for women with ovarian cancer, and it may also be linked to better survival rates for endometrial cancer patients. Physical activity during and after cancer treatment is associated with less distress and improved psychosocial outcomes. ^{1 2 3 4 5}

Is exercise safe for ovarian and endometrial cancer patients?

Research suggests that exercise is generally safe for women with ovarian cancer, including those undergoing treatment. However, specific guidelines for exercise in ovarian cancer survivors are still being developed, and more research is needed to tailor exercise programs to individual needs. ^{1 2 3 6 7}

How does exercise as a treatment differ from other treatments for ovarian and endometrial cancer?

Exercise is unique because it focuses on improving physical activity levels to enhance body composition and reduce cancer risk, rather than using medication or surgery. It has been shown to improve survival rates and physical well-being, especially when combined with traditional treatments like chemotherapy. ^{1 3 8 9 10}

Research Team

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Exercise during CHemotherapy for Ovarian cancer (ECHO) trial: design and implementation of a randomised controlled trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of exercise interventions for women during and after gynaecological cancer treatment - a systematic scoping review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Physical activity in women with ovarian cancer and its association with decreased distress and improved quality of life. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Prospective Cohort Study of Pre- and Postdiagnosis Physical Activity and Endometrial Cancer Survival. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Recreational physical activity and ovarian cancer risk in African American women. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A Physiological Profile of Ovarian Cancer Survivors to Inform Tailored Exercise Interventions and the Development of Exercise Oncology Guidelines. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of exercise on body composition among women with ovarian cancer. [2023]

9. England 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. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of post-surgical physical activity in endometrial and ovarian cancer patients. [2020]