Ovarian CancerNCT04204811
Prehabilitation Care for Women With Advanced Ovarian Cancer Receiving Neoadjuvant Chemotherapy
A study testing Prehabilitation in people with Ovarian Cancer and Stage III Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is evaluate whether a prehabilitation program is feasible and useful for women with advanced ovarian cancer receiving chemotherapy in preparation for debulking surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Stage III Ovarian Cancer, Stage IV Ovarian Cancer
- What is being tested?
- Prehabilitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2019to 16 Dec 2026
- 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
- Subjects must be diagnosed with Stage III or Stage IV ovarian carcinoma (which includes primary peritoneal carcinoma or fallopian rube carcinoma)
- All subjects must be enrolled within 90 days of diagnosis
- No prior treatment for ovarian carcinoma
- All subjects have agreed to a treatment plan of neoadjuvant chemotherapy and subsequent planned interval debulking surgery with an MSKCC surgeon
- Participants must be initiating treatment at Gynecologic Medical Oncology clinics at MSKCC Manhattan
- Proficiency in English in the determination of the investigators of by patient self-report
Who cannot join
- Patient under age 18
- Prior treatment for ovarian cancer
- Second opinion visit only
- Immediate surgery plan without neoadjuvant treatment
- No intended surgical plan
- Chemotherapy administration exclusively planned at MSKCC regional site
- Patient unwilling to sign consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Pilot Project to Evaluate Feasibility and Patient Experience of Prehabilitation Care for Women With Advanced Ovarian Cancer Undergoing Neoadjuvant Chemotherapy
The purpose of this study is evaluate whether a prehabilitation program is feasible and useful for women with advanced ovarian cancer receiving chemotherapy in preparation for debulking surgery.
- Conditions
- Ovarian Cancer, Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Carcinoma, Fallopian Tube Cancer
- Being tested
- Prehabilitation
- Keywords
- Ovarian Cancer, Primary peritoneal carcinoma, Fallopian tube cancer, 19-347, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
A program of personalized independent home exercises are outline for participants to complete daily. Prehabilitation coaching will continue weekly until admission for surgical tumor debulking or termination of neoadjuvant treatment for any reason.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Ovarian Cancer | Experimental | Participants are diagnosed with Stage III or Stage IV ovarian carcinoma (which includes primary peritoneal carcinoma or fallopian tube carcinoma) Receives: Other: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median completion of participants
Study will be considered feasible if the cohort has a median completion of 70% or more
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start16 Dec 2019
- Primary completion16 Dec 2026 (estimated)
- Study completion16 Dec 2026 (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 Memorial Sloan Kettering 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theresa Gillis, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204811
- Sponsor's protocol ID
- 19-347
- Status last verified
- Jan 2026
- First submitted
- 17 Dec 2019
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Project to Evaluate Feasibility and Patient Experience of Prehabilitation Care for Women With Advanced Ovarian Cancer Undergoing Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04204811
- Acronym / sponsor ID
- 19-347
- Conditions
- Ovarian Cancer, Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Carcinoma, Fallopian Tube Cancer
- Keywords
- Ovarian Cancer, Primary peritoneal carcinoma, Fallopian tube cancer, 19-347, Memorial Sloan Kettering Cancer Center
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 16 Dec 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 19 Dec 2019 (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.
The purpose of this study is evaluate whether a prehabilitation program is feasible and useful for women with advanced ovarian cancer receiving chemotherapy in preparation for debulking surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Ovarian Cancer | Experimental | Other: PrehabilitationParticipants are diagnosed with Stage III or Stage IV ovarian carcinoma (which includes primary peritoneal carcinoma or fallopian tube carcinoma) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be diagnosed with Stage III or Stage IV ovarian carcinoma (which includes primary peritoneal carcinoma or fallopian rube carcinoma)
- All subjects must be enrolled within 90 days of diagnosis
- No prior treatment for ovarian carcinoma
- All subjects have agreed to a treatment plan of neoadjuvant chemotherapy and subsequent planned interval debulking surgery with an MSKCC surgeon
- Participants must be initiating treatment at Gynecologic Medical Oncology clinics at MSKCC Manhattan
Key exclusion criteria (7 listed)
- Patient under age 18
- Prior treatment for ovarian cancer
- Second opinion visit only
- Immediate surgery plan without neoadjuvant treatment
- No intended surgical plan
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 |
|---|---|---|
| PrehabilitationA program of personalized independent home exercises are outline for participants to complete daily. Prehabilitation coaching will continue weekly until admission for surgical tumor debulking or termination of neoadjuvant treatment for any reason. | Other | Participants with Ovarian Cancer |
Primary outcome
Median completion of participants
Time frame: Up to 1 year
Study will be considered feasible if the cohort has a median completion of 70% or more
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 7 Jan 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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. This study is not recruiting at the moment.
Theresa Gillis, MD principal investigator
Memorial Sloan Kettering 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 Prehabilitation in people with Ovarian Cancer and Stage III Ovarian Cancer, run by Memorial Sloan Kettering 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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median completion of participants (time frame: Up to 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 7 Jan 2026.