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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04622670.
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 yoga instruction materials (such as a manual and video via electronic link or physical medium) during and after CRT.
GROUP II (WAIT LIST CONTROL): Patients refrain from participating in any new stress management activities and receive yoga instruction materials (such as a manual and video via electronic link or physical medium). Patients are also offered 4 group yoga classes 3 months after CRT. Patients also complete surveys as in Group I.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorLois M. Ramondetta