Trials / Active Not Recruiting

Active Not RecruitingNCT04622670

Yoga Therapy During Chemotherapy and Radiation Treatment for the Improvement of Physical and Emotional Well-Being in Patients With Stage IB2-IIIB Cervical Cancer

Yoga Therapy During Chemotherapy and Radiation Treatment for Local-Regional Cervical Cancer

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 40 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
OTHER	Media Intervention	Receive DVD
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Survey Administration	Ancillary studies
PROCEDURE	Yoga	Attend yoga class

Timeline

Start date: 2020-03-10
Primary completion: 2027-01-31
Completion: 2027-01-31
First posted: 2020-11-10
Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04622670. Inclusion in this directory is not an endorsement.