Yoga Therapy for Cervical Cancer

Overseen By Donna Griffin

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Second cancer, Psychiatric, others

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

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether yoga therapy can enhance physical and emotional well-being for individuals undergoing chemotherapy and radiation for cervical cancer. Participants will either join a yoga group or be placed on a waitlist, with both groups completing surveys about their well-being. Those with cervical cancer at certain stages (IB2-IIIB) who plan to have outpatient treatment might be a good fit. Yoga therapy includes exercises, meditation, and breathing techniques to help balance the mind and body during treatment. As an unphased trial, this study offers a unique opportunity to explore the potential benefits of yoga therapy alongside conventional treatments.

Do I need to stop my current medications for the yoga therapy trial?

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 yoga therapy is safe for cervical cancer patients?

Research has shown that yoga therapy is very safe for people with cancer, including those with gynecological cancers like cervical cancer. Past studies reported no harmful side effects. Yoga improves mental health, quality of life, and reduces tiredness, helping people feel better both physically and emotionally. Increased activity through yoga is safe for most adults with cancer and offers many health benefits. For those considering joining a yoga therapy trial, evidence suggests it is a safe and helpful practice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about yoga therapy for cervical cancer patients because it offers a non-invasive way to potentially improve quality of life during treatment. Unlike standard treatments like surgery, radiation, or chemotherapy, which focus on directly attacking cancer cells, yoga therapy aims to reduce stress, enhance emotional well-being, and improve physical fitness through guided exercises and mindfulness. The unique aspect of this approach is its holistic focus on the patient’s overall well-being, which could complement traditional cancer treatments and help alleviate some of their side effects. Additionally, it empowers patients by giving them tools to manage stress and maintain physical activity, which are crucial during the challenging treatment process.

What evidence suggests that yoga therapy is effective for improving well-being in cervical cancer patients?

This trial will compare yoga therapy with a waitlist control group for patients with cervical cancer. Research has shown that yoga therapy can enhance both physical and emotional well-being in these patients. Studies have found that yoga improves quality of life, reduces fatigue, and elevates mood in women with gynecological cancers. It also lowers stress and strengthens coping skills during challenging treatments. Specifically, another study found that yoga helped women with cervical cancer by reducing anxiety and depression while boosting spiritual and emotional well-being. Importantly, no negative effects related to yoga were reported, making it a safe option to consider. ^{1 2 3 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 English-speaking patients with stage IB2-IIIB cervical cancer who are fit enough to undergo chemotherapy and radiation (ECOG score ≤2). They must be treated at MD Anderson Cancer Center and not have had a hysterectomy, neuroendocrine histology, severe psychiatric conditions, extreme mobility issues, or a regular yoga practice recently.

Inclusion Criteria

I can do most things for myself but might be unable to do heavy physical work.

My cervical cancer is stage IB2 to IIIB and I plan to have treatment aimed at curing it at MD Anderson.

Exclusion Criteria

I don't have health issues that would stop me from doing yoga.

I have severe difficulty moving around.

Patients with major psychiatric diagnoses (e.g., schizophrenia, bipolar disorder)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy and Radiation Treatment

Participants undergo chemotherapy and radiation therapy while attending yoga classes

5-6 weeks

At least 2 yoga classes per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 months

Optional Yoga Classes

Participants in the wait list control group are offered 4 group yoga classes

After 3 months of CRT

What Are the Treatments Tested in This Trial?

Interventions

• Yoga Therapy

Trial Overview The study examines the effectiveness of yoga therapy as an addition to standard chemotherapy and radiation in improving physical and emotional well-being. It involves exercise, meditation, breathing control during cancer treatment.

How Is the Trial Designed?

Group I: Group I (yoga group) Experimental Treatment 5 Interventions

Patients attend at least 2 yoga classes per week over 5-6 weeks lasting approximately 60 minutes each for up to 15 classes during the CRT. Patients also complete surveys pre-treatment, once a week, and post-treatment over and receive a yoga manual and DVD during and after CRT.

Group II: Group II (wait list control) Active Control 4 Interventions

Patients refrain from participating in any new stress management activities and receive a DVD. Patients are also offered 4 group yoga classes after 3 months of CRT. Patients also complete surveys as in Group I.

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 68 breast cancer patients undergoing radiotherapy, an integrated yoga program significantly reduced anxiety and depression levels, as measured by the Hospital Anxiety and Depression Scale (HADS), while the control group experienced increased anxiety and depression.

Although both groups showed elevated radiation-induced DNA damage after treatment, the yoga group exhibited slightly less DNA damage compared to the control group, suggesting that yoga may help mitigate some of the negative effects of radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an integrated yoga program in modulating psychological stress and radiation-induced genotoxic stress in breast cancer patients undergoing radiotherapy. Banerjee, B., Vadiraj, HS., Ram, A., et al.[2022]

A review of eight nonrandomized studies indicates that yoga is feasible and safe for children and adolescents with cancer, with retention rates around 70% and positive participant feedback.

Preliminary findings suggest that yoga may significantly improve health-related quality of life (HRQL) by reducing symptoms like anxiety and pain in pediatric oncology patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga in the Pediatric Oncology Population: A Review of the Literature. Spector, D.[2021]

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]

Yoga significantly reduces distress, anxiety, and depression in cancer patients undergoing radiotherapy, indicating its potential as a supportive therapy during treatment.

While yoga shows moderate benefits for fatigue and emotional function, the evidence for its effects on overall psychological outcomes and functional well-being is limited, suggesting the need for further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing Yoga in Oncologic Patients Treated with Radiotherapy: Review. Tolia, M., Tsoukalas, N., Nikolaou, M., et al.[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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12142155/

Impact of an educational physiotherapy-yoga intervention on ... In conclusion, evidence supports the use of yoga and patient education for improving psychological and physical symptoms in patients undergoing ...

2. scholarworks.wmich.edu scholarworks.wmich.edu/cgi/viewcontent.cgi?article=2383&context=ojot

Effects of Yoga on the Mental Health of Women with ... No adverse events related to yoga were reported. Conclusion Conclusion: The results of this review indicate that yoga is a safe and beneficial ...

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/PMC11002714/

A Randomized Controlled Trial on Pranayama and Yoga ... In this study, we used the techniques of Yoga Nidra and Pranayama to evaluate their effect on patients with cervical cancer undergoing standard care.

5. karger.com karger.com/pps/article/94/4/289/926167/Effect-of-Yoga-on-Psychological-and-Spiritual

Effect of Yoga on Psychological and Spiritual Outcomes in ... Conclusion: Yoga effectively reduces anxiety and depression and improves spiritual well-being and emotional well-being in cancer, underscoring ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10790429/

A single-subject research design evaluating a co-created ... Becoming more physically active, through yoga, is very safe for most adults diagnosed with cancer and can yield many health benefits [18, 60, 61] ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04622670

Yoga Therapy During Chemotherapy and Radiation ... This trial studies how well yoga therapy works during chemotherapy and radiation treatment in improving physical and emotional well-being in patients with ...