Ovarian CancerNCT06545604
Comprehensive Yoga Therapy Based Lifestyle Prehabilitation Program for Women With Ovarian Cancer
A study testing Yoga Therapy for Nutritional, Physical, and Psychosocial Prehabilitation in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Yoga Therapy for Nutritional, Physical, and Psychosocial Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 18 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.
- 9. Plan for surgical intervention at MD Anderson Cancer Center 9. Performance status 0-2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Lois Ramondetta, MD, 713-745-0307, lramonde@mdanderson.org
About this study
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.
Read the detailed description
Primary Objectives:
Primary Objective: to assess the feasibility of a CYT prehabilitation program in women with ovarian cancer scheduled to receive NACT and IDS. Feasibility criteria will include the percent of eligible patients who consent to participate (feasibility is defined as 30% of those approached and are eligible end up consenting) and study retention by the last follow-up (feasibility is defined as 60% of those undergoing surgery remaining in the study and providing some data at baseline and at last follow-up timepoint).
Secondary Objectives:
- 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 WLC.
- 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.
- Examine group differences in patient-reported outcomes including QOL, fatigue, stress, sleep disturbances, mental health, social support, and mindfulness.
- Examine if there are group differences in preoperative albumin level, vit D, magnesium levels.
- Examine group differences and changes over time in microbiome biodiversity.
- Examine group differences in body composition (sarcopenia) as measured by routine abdominal CT scans.
- Explore the association between adherence to the components of CYT with ability to sustain behavior changes and between changes in lifestyle parameters with outcomes. This will be explored both within and across groups.
- Conditions
- Ovarian Cancer
- Being tested
- Yoga Therapy for Nutritional, Physical, and Psychosocial Prehabilitation, Usual care supportive services including nutrition counseling per usual care
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga Therapy for Nutritional, Physical, and Psychosocial PrehabilitationOther
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.
Usual care supportive services including nutrition counseling per usual careOther
Usual care supportive services while receiving neoadjuvant chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CYT - Prehab Yoga Intervention + ERAS | Experimental | Not described Receives: Other: Yoga Therapy for Nutritional, Physical, and Psychosocial Prehabilitation |
| WLC - Wait List Control + ERAS | Experimental | Not described Receives: Other: Usual care supportive services including nutrition counseling per usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of a CYT prehabilitation program in women with ovarian cancer scheduled to receive NACT and IDS.
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start6 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lois Ramondetta, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545604
- Sponsor's protocol ID
- 2024-0374
- Other IDs
- NCI-2024-06338
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Yoga Therapy Based Lifestyle Prehabilitation Program for Women With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06545604
- Acronym / sponsor ID
- 2024-0374
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objectives:
Primary Objective: to assess the feasibility of a CYT prehabilitation program in women with ovarian cancer scheduled to receive NACT and IDS. Feasibility criteria will include the percent of eligible patients who consent to participate (feasibility is defined as 30% of those approached and are eligible end up consenting) and study retention by the last follow-up (feasibility is defined as 60% of those undergoing surgery remaining in the study and providing some data at baseline and at last follow-up timepoint).
Secondary Objectives:
- 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 WLC.
- 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.
- Examine group differences in patient-reported outcomes including QOL, fatigue, stress, sleep disturbances, mental health, social support, and mindfulness.
- Examine if there are group differences in preoperative albumin level, vit D, magnesium levels.
- Examine group differences and changes over time in microbiome biodiversity.
- Examine group differences in body composition (sarcopenia) as measured by routine abdominal CT scans.
- Explore the association between adherence to the components of CYT with ability to sustain behavior changes and between changes in lifestyle parameters with outcomes. This will be explored both within and across groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 18 years of age or older.
- Oriented to person, place, and time.
- Access to internet connection.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga Therapy for Nutritional, Physical, and Psychosocial PrehabilitationTwo 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. | Other | CYT - Prehab Yoga Intervention + ERAS |
| Usual care supportive services including nutrition counseling per usual careUsual care supportive services while receiving neoadjuvant chemotherapy. | Other | WLC - Wait List Control + ERAS |
Primary outcome
To assess the feasibility of a CYT prehabilitation program in women with ovarian cancer scheduled to receive NACT and IDS.
Time frame: Through study completion; an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lois Ramondetta, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Therapy for Nutritional, Physical, and Psychosocial Prehabilitation in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lois Ramondetta, MD ((713) 745-0307, lramonde@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility of a CYT prehabilitation program in women with ovarian cancer scheduled to receive NACT and IDS. (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.