Yoga Therapy for Ovarian Cancer

Overseen By Lois Ramondetta, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Completed chemotherapy, Thought disorder, Communication barriers, Extreme mobility issues

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how yoga therapy can improve life for patients with certain types of advanced cancer, such as ovarian cancer, who are about to start chemotherapy. Researchers aim to determine if participating in a comprehensive yoga program before surgery can enhance patients' quality of life. There are two groups: one will start the yoga program before surgery, and the other will be on a waitlist. Women with advanced ovarian, fallopian tube, or primary peritoneal cancer who are planning surgery at MD Anderson Cancer Center and have internet access might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to explore innovative ways to improve well-being during cancer treatment.

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 the trial coordinators or your doctor.

What prior data suggests that this comprehensive yoga therapy is safe for patients with ovarian cancer?

Research has shown that yoga is generally safe for people, including those with cancer. Studies have found that it can improve physical and mental symptoms without causing major side effects. For instance, many cancer patients report feeling less stressed and sleeping better with yoga. They also experience some relief from anxiety, depression, and fatigue.

In past studies, participants did not report any serious problems from practicing yoga, indicating it is usually well-tolerated. Comprehensive Yoga Therapy (CYT) aims to improve the quality of life for women with gynecological cancers, such as ovarian cancer. Overall, yoga, including CYT, is considered a safe option for people undergoing cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Comprehensive Yoga Therapy for ovarian cancer because it offers a holistic approach that differs from conventional treatments like surgery, chemotherapy, and radiation. While traditional methods focus on directly targeting cancer cells, yoga therapy aims to improve overall well-being, reduce stress, and enhance quality of life, which can be crucial for recovery and resilience. This technique is particularly appealing as it might help manage side effects, support mental health, and empower patients with active participation in their healing journey.

What evidence suggests that Comprehensive Yoga Therapy is effective for improving quality of life in ovarian cancer patients?

This trial will compare Comprehensive Yoga Therapy (CYT) with a wait list control group. Research has shown that yoga, including CYT, can enhance mental well-being and quality of life for cancer patients. Studies have found that yoga reduces fatigue and elevates mood, addressing common challenges during cancer treatment. It also helps individuals manage stress and reduces anxiety and depression. Some research even suggests that yoga improves sleep. Overall, these benefits significantly impact how patients feel during and after treatment. ^{2 4 5 6 7}

Who Is on the Research Team?

Lois M Ramondetta

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for women with ovarian, fallopian tube, or primary peritoneal cancer who are about to start chemotherapy and have surgery planned. Details on specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I have advanced ovarian, fallopian tube, or peritoneal cancer and am recommended for chemotherapy before surgery.

I can take care of myself and perform daily activities.

Access to internet connection

Exclusion Criteria

I cannot get in and out of a chair without help.

Any major thought disorder (e.g., schizophrenia, dementia)

Any major communication barriers that would preclude being able to complete the intervention (e.g., visually or hearing impaired)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a comprehensive yoga therapy (CYT) program to improve physical conditioning and quality of life before chemotherapy and surgery

6-8 weeks

Chemotherapy

Participants receive neoadjuvant chemotherapy (NACT) as part of their treatment plan

9-12 weeks

Surgery

Participants undergo interval debulking surgery (IDS) following chemotherapy

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and physical conditioning

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Yoga Therapy

Trial Overview The study tests a Comprehensive Yoga Therapy (CYT) program designed as prehabilitation for nutritional, physical, and psychosocial support before patients undergo chemotherapy and surgery.

How Is the Trial Designed?

Group I: WLC - Wait List Control + ERAS Experimental Treatment 2 Interventions

Group II: CYT - Prehab Yoga Intervention + ERAS Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

In a study of 2508 yoga class attendees, about 27.8% reported experiencing adverse events, primarily mild musculoskeletal symptoms, indicating that while yoga is generally safe, some participants may face risks, especially those with chronic conditions.

Participants with chronic diseases, poor physical condition, or those who found the class stressful had a higher likelihood of experiencing adverse events, particularly severe ones in elderly individuals and those with chronic musculoskeletal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A large-scale survey of adverse events experienced in yoga classes. Matsushita, T., Oka, T.[2022]

A one-on-one yoga therapy session delivered via telehealth significantly reduced physical and global distress in cancer patients, with notable improvements in anxiety and fatigue, based on data from 95 patient encounters.

The study highlights the potential of yoga therapy as an effective complementary treatment in oncology, suggesting that even a single session can lead to meaningful symptom relief, warranting further research on long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga Therapy in Cancer Care via Telehealth During the COVID-19 Pandemic. Mallaiah, S., Narayanan, S., Wagner, R., et al.[2022]

Therapeutic yoga has been shown to improve various aspects of quality of life for cancer patients, including better sleep, reduced anxiety and depression, and enhanced spiritual well-being, based on a review of multiple studies.

The absence of side effects and the positive feedback from participants suggest that yoga could be a beneficial complementary therapy for cancer patients, although the studies had methodological limitations that warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of yoga on patients with cancer: our current understanding. Côté, A., Daneault, S.[2022]

Citations

1. withpower.com withpower.com/trial/phase-carcinoma-ovarian-epithelial-2025-f0bbe

Yoga Therapy for Ovarian Cancer Research shows that yoga, including restorative yoga, can improve mental health, reduce fatigue, and enhance quality of life in cancer patients, including those ...

2. ctv.veeva.com ctv.veeva.com/study/comprehensive-yoga-therapy-based-lifestyle-prehabilitation-program-for-women-with-ovarian-cancer

Comprehensive Yoga Therapy Based Lifestyle Prehabilitation ... Researchers want to learn about the effects of the program on patients' quality of life and other outcomes described below.

3. cureus.com cureus.com/articles/418273-effects-of-yoga-interventions-on-health-outcomes-in-women-with-gynecological-cancers-a-systematic-review-of-randomised-controlled-trials

Effects of Yoga Interventions on Health Outcomes in ... Preliminary outcomes from these studies include enhanced QoL, reduced fatigue, improved mood, better coping mechanisms, and decreased distress, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11817149/

The Effects of Online Yoga Practice on Cancer Patients Results: The results suggest that online yoga can improve stress and sleep quality, with moderate effects on anxiety, depression, and fatigue.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00337233

Yoga in Controlling Symptoms and Reducing Stress ... RATIONALE: Yoga may improve symptoms and quality of life and reduce stress in patients with ovarian cancer or breast cancer and may help them live more ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06545604?cond=ovarian+cancer&aggFilters=status%3A%2Cphase%3A

Comprehensive Yoga Therapy Based Lifestyle Prehabilitation ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. cureus.com cureus.com/articles/418273-effects-of-yoga-interventions-on-health-outcomes-in-women-with-gynecological-cancers-a-systematic-review-of-randomised-controlled-trials.pdf?email=

Effects of Yoga Interventions on Health Outcomes in Women ... Gynaecological cancers have a profound impact on women's health, with survivors often experiencing a diminished quality of life (QoL) owing to ...