NCT06545604

Brief Summary

To provide a comprehensive yoga therapy (CYT) program to patients with ovarian, fallopian tube, or primary peritoneal cancer who are scheduled to receive chemotherapy and then undergo surgery. Researchers want to learn about the effects of the program on patients' quality of life and other outcomes described below.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable ovarian-cancer

Timeline
13mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jun 2025Jun 2027

First Submitted

Initial submission to the registry

August 5, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

June 6, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

August 5, 2024

Last Update Submit

November 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • To assess the feasibility of a CYT prehabilitation program in women with ovarian cancer scheduled to receive NACT and IDS.

    Through study completion; an average of 1 year

Study Arms (2)

CYT - Prehab Yoga Intervention + ERAS

EXPERIMENTAL
Other: Yoga Therapy for Nutritional, Physical, and Psychosocial Prehabilitation

WLC - Wait List Control + ERAS

EXPERIMENTAL
Other: Usual care supportive services including nutrition counseling per usual care

Interventions

Two visits per week with a yoga therapist while receiving neoadjuvant chemotherapy to cover dietary counseling, yoga-based movement practices, breathwork practices, mind practices, and behavioral support for the purpose of preparing patients' mind and body for a planned surgery.

CYT - Prehab Yoga Intervention + ERAS

Usual care supportive services while receiving neoadjuvant chemotherapy.

WLC - Wait List Control + ERAS

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with stage III-IV epithelial ovarian, fallopian tube, primary peritonal cancer with recommendations for NACT/IDS at recruitment.
  • Able to read, write, and speak English.
  • years of age or older.
  • Oriented to person, place, and time.
  • Access to internet connection.
  • Access to a tablet, laptop or computer or smart phone.
  • Access and ability to do virtual sessions.
  • \. Plan for surgical intervention at MD Anderson Cancer Center 9. Performance status 0-2.

You may not qualify if:

  • Have completed chemotherapy.
  • Any major thought disorder (e.g., schizophrenia, dementia).
  • Any major communication barriers that would preclude being able to complete the intervention (e.g., visually or hearing impaired).
  • Extreme mobility issues (e.g., unable to get in and out of a chair unassisted).
  • Have a regular mind-body practice or an established yoga practice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

YogaRestraint, Physical

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesBehavior ControlImmobilizationInvestigative Techniques

Study Officials

  • Lois Ramondetta, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lois Ramondetta, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2024

First Posted

August 9, 2024

Study Start

June 6, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

November 26, 2025

Record last verified: 2025-11

Locations