This clinical trial studies how well a comprehensive yoga therapy (CYT) program works in improving outcomes in women with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer who are scheduled to receive chemotherapy and then undergo surgery. The CYT program occurs during chemotherapy and includes yoga-based physical practices, breathwork techniques, meditation, nutritional support, and behavioral support. Surgical prehabilitation programs combining physical, nutritional, and psychological interventions have shown better surgical outcomes and fewer post-operative complications. However, there is not a comprehensive prehabilitation program that includes physical, psychological, and nutritional support for women being treated for ovarian cancer. This program hopes to prepare patients' minds and bodies for the planned surgery while teaching techniques that can be used after the trial is completed. CYT may improve the well-being, quality of life and outcomes in patients with ovarian cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06545604.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Lois M. Ramondetta
PRIMARY OBJECTIVE:
I. To assess the feasibility of a CYT prehabilitation program in women with ovarian cancer scheduled to receive neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS).
SECONDARY OBJECTIVES:
I. Examine the effects of the CYT program on physical conditioning as assessed by the 2-minute step test (2MST) and sit to stand reps (30secSTS) compared with wait-list control (WLC).
II. Examine group differences in surgical outcomes including post op stay, readmission rate, post op morbidity, surgical site infection rate, and time to first chemotherapy post operatively.
III. Examine group differences in patient-reported outcomes including quality of life (QOL), fatigue, stress, sleep
disturbances, mental health, social support, and mindfulness.
IV: Examine if there are group differences in preoperative albumin level, vitamin (vit) D, magnesium levels.
V: Examine group differences and changes over time in microbiome biodiversity.
VI: Examine group differences in body composition (sarcopenia) as measured by routine abdominal computed tomography (CT) scans.
VII: Explore the association between adherence to the components of CYT with ability to sustain behavior changes and between changes in lifestyle parameters with outcomes.
OUTLINE: Patients are randomized to 1 of 2 arms.
GROUP I (CYT PROGRAM): Patients undergo the CYT program comprising yoga-based physical practices, breathwork, meditation, nutrition support and behavioral support administered by a certified yoga therapist weekly over 9-12 weeks during NACT on study.
GROUP II (WAIT LIST CONTROL GROUP): Patients undergo usual care supportive services during NACT on study as well as receive recommendations for walking 30 minutes at least 3 times per week (TIW), to follow a plant centered diet, education materials and Fitbit watch activity trackers on study. After the last follow up session, patients may undergo 3 sessions of the CYT program.
Additionally, patients undergo collection of blood and stool samples as well as usual care computed tomography (CT) scans throughout the trial.
After completion of study intervention, patients are followed up 3-5 weeks post-surgery.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorLois M. Ramondetta
