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Yoga Therapy During Chemotherapy and Radiation Treatment for Local-Regional Cervical Cancer
This trial studies how well yoga therapy works during chemotherapy and radiation treatment in improving physical and emotional well-being in patients with stage IB2-IIIB cervical cancer. Yoga therapy may help to balance the mind and body through exercise, meditation (focusing thoughts), and control of breathing and emotions.
PRIMARY OBJECTIVE: I. Establish feasibility of delivering a yoga therapy program during chemotherapy and radiation therapy (CRT) for loco-regionally advanced cervical cancer undergoing chemo-radiotherapy. SECONDARY OBJECTIVES: I. Measure the effects and variance of yoga on fatigue, depression, anxiety, pelvic pain and over-all quality of life (QOL) in cervical cancer (CxCa) patients undergoing primary treatment with CRT. II. Examine changes in other psychosocial outcomes including ability to find meaning in the illness, spirituality and sexuality. EXPLORATORY OBJECTIVE: I. Evaluate whether markers of stress response (plasma levels of other pro-inflammatory cytokines, including interleukin-6 \[IL-6\], and IL-8, IL-10, VEGF, and CRP) change in response to yoga therapy and their association with fatigue, depression, anxiety, pelvic pain, meaning in the illness, experience, spirituality, and QOL in CxCa patients undergoing primary CRT. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (YOGA GROUP): 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 and receive a yoga manual and DVD during and after CRT. GROUP II (WAIT LIST CONTROL): 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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
M D Anderson Cancer Center
Houston, Texas, United States
Start Date
March 10, 2020
Primary Completion Date
January 31, 2027
Completion Date
January 31, 2027
Last Updated
January 20, 2026
40
ACTUAL participants
Media Intervention
OTHER
Quality-of-Life Assessment
OTHER
Questionnaire Administration
OTHER
Survey Administration
OTHER
Yoga
PROCEDURE
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT05639972
NCT06654011
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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