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

Trial Summary

What is the purpose of this trial?

This trial studies how yoga therapy can help patients with advanced cervical cancer who are receiving chemotherapy and radiation. Yoga involves exercises, meditation, and breathing techniques to improve physical and emotional well-being. The goal is to see if yoga can reduce stress, anxiety, and pain, and enhance overall quality of life during treatment. Yoga has been shown to provide physical and psychological benefits for cancer patients, including reducing fatigue, stress, and improving quality of life.

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 data supports the effectiveness of the treatment Yoga Therapy for cervical cancer?

Research shows that yoga therapy can improve physical and mental health in cancer patients, including those undergoing radiotherapy. It has been associated with better quality of life, general health perception, and physical functioning in women with breast cancer, suggesting potential benefits for cervical cancer patients as well. ^{1 2 3 4 5}

Is yoga therapy safe for people with cancer?

Research shows that yoga is generally safe for people with cancer, with no serious adverse events reported in studies. It has been used safely in both children and adults with cancer, and it may help improve quality of life and reduce stress. ^{3 6 7 8 9}

How does yoga therapy differ from other treatments for cervical cancer?

Yoga therapy for cervical cancer is unique because it focuses on holistic well-being, potentially helping to manage symptoms and improve quality of life, unlike conventional treatments like surgery, chemotherapy, and radiation, which directly target the cancer itself. ^{10 11 12 13 14}

Research Team

Lois M Ramondetta

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Able to speak English

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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 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]

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 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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Yoga improves quality of life and benefit finding in women undergoing radiotherapy for breast cancer. [2022]

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

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

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

Utilizing Yoga in Oncologic Patients Treated with Radiotherapy: Review. [2022]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Exploring women's experiences participating in yoga after a cancer diagnosis: a protocol for a meta-synthesis. [2022]

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

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

7. United States 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. [2022]

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

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

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

Yoga Therapy During Chemotherapy for Early-Stage and Locally Advanced Breast Cancer. [2023]

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

Adjuvant phytotherapy in the treatment of cervical cancer: a systematic review and meta-analysis. [2018]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Induction chemotherapy for locally advanced cervical cancer]. [2015]

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

The Symptom Experience and Self-management Strategies of Women Undergoing Cervical Cancer Treatment: A Qualitative Study. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Advances in the management of cervical cancer. [2019]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Current and potential treatments for cervical cancer. [2022]