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Yoga Therapy for Cervical Cancer

N/A
Waitlist Available
Led By Lois M Ramondetta
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Score of =< 2 on Eastern Cooperative Oncology Group (ECOG) performance scale
Federation of Gynecology and Obstetrics (FIGO) stage IB2 through IIIB biopsy-proven CxCa (adenocarcinoma, squamous cell carcinoma, and adenosquamous) with plan to undergo curative outpatient CRT at main campus MD Anderson Cancer Center
Must not have
Patients with extreme mobility issues
Prior hysterectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 3 months post crt
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Yoga is generally safe but may include muscle soreness or strain. Emotional side effects could arise from confronting difficult emotions during meditation. The risk of injury exists if poses are performed incorrectly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most things for myself but might be unable to do heavy physical work.
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My cervical cancer is stage IB2 to IIIB and I plan to have treatment aimed at curing it at MD Anderson.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe difficulty moving around.
Select...
I have had a hysterectomy.
Select...
My cancer is of neuroendocrine type.
Select...
I have a health condition that prevents me from receiving full-dose chemotherapy.
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I have been diagnosed with another type of cancer besides the one being treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 3 months post crt
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 3 months post crt for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to the yoga therapy protocol
Completion in the yoga therapy protocol
Yoga
Secondary study objectives
Brief Fatigue Inventory Scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (yoga group)Experimental Treatment5 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 Control4 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Yoga
2008
Completed Phase 3
~3830

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Cervical Adenocarcinoma include surgery, radiation therapy, and chemotherapy. Surgery involves the physical removal of cancerous tissues, radiation therapy uses high-energy rays to kill cancer cells, and chemotherapy employs drugs to target and destroy cancer cells. These treatments can be physically and emotionally taxing. Integrative therapies like yoga, which focus on balancing the mind and body through exercise, meditation, and controlled breathing, can help manage treatment-related symptoms, reduce stress, and improve overall quality of life. This holistic approach is particularly beneficial for Cervical Adenocarcinoma patients as it supports both physical recovery and emotional resilience during conventional cancer treatments.
Nonpharmacologic complementary therapies in symptom management for breast cancer survivors.Integrative medicine: complementary therapies and supplements.Proportion of gynecologic cancer patients using complementary and alternative medicine.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,768 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,130 Total Patients Enrolled
Lois M RamondettaPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

Yoga Clinical Trial Eligibility Overview. Trial Name: NCT04622670 — N/A
Cervical Adenocarcinoma Research Study Groups: Group I (yoga group), Group II (wait list control)
Cervical Adenocarcinoma Clinical Trial 2023: Yoga Highlights & Side Effects. Trial Name: NCT04622670 — N/A
Yoga 2023 Treatment Timeline for Medical Study. Trial Name: NCT04622670 — N/A
~1 spots leftby Jan 2025