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

44 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Comprehensive 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 with ovarian cancer. Participants in yoga programs reported feeling less depressed and anxious, and experienced better overall well-being. ^{1 2 3 4 5}

Is yoga therapy safe for humans, including those with cancer?

Yoga is generally considered safe for humans, including those with cancer, as most studies report improvements in physical and psychological symptoms without serious adverse events. However, some nonserious adverse events have been noted, especially when compared to psychological or educational interventions. ^{5 6 7 8 9}

How does Comprehensive Yoga Therapy differ from other treatments for ovarian cancer?

Comprehensive Yoga Therapy is unique because it focuses on improving both physical and mental health through a mind-body practice, which includes physical postures, breathing, and deep relaxation. Unlike traditional cancer treatments like surgery or chemotherapy, yoga therapy aims to enhance quality of life, reduce fatigue, and alleviate psychological distress without the use of medication. ^{1 2 3 4 5}

What is the purpose of this trial?

To provide a comprehensive yoga therapy (CYT) program to patients with ovarian, fallopian tube, or primary peritoneal cancer who are scheduled to receive chemotherapy and then undergo surgery. Researchers want to learn about the effects of the program on patients' quality of life and other outcomes described below.

Research Team

Lois M Ramondetta

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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 am aware of who I am, where I am, and the current time.

Access to internet connection

Exclusion Criteria

I have finished my chemotherapy treatments.

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

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

Treatment Details

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.

Participant Groups

Group I: WLC - Wait List Control + ERAS Experimental Treatment 1 Intervention

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+

Findings from Research

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]

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]

References

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

Yoga Therapy in Cancer Care via Telehealth During the COVID-19 Pandemic. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Restorative yoga for women with ovarian or breast cancer: findings from a pilot study. [2022]

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

Longitudinal assessment of quality of life and lifestyle in newly diagnosed ovarian cancer patients: the roles of surgery and chemotherapy. [2006]

4. Canada pubmed.ncbi.nlm.nih.gov

Effect of yoga on patients with cancer: our current understanding. [2022]

5. Scotland pubmed.ncbi.nlm.nih.gov

"I'm 100% for it! I'm a convert!": women's experiences of a yoga programme during treatment for gynaecological cancer; an interpretative phenomenological analysis. [2015]

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

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

7. India pubmed.ncbi.nlm.nih.gov

Yoga into Cancer Care: A Review of the Evidence-based Research. [2020]

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

Adverse events associated with complementary and alternative medicine use in ovarian cancer patients. [2021]

9. England pubmed.ncbi.nlm.nih.gov

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