NCT04204811

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable ovarian-cancer

Timeline
7mo left

Started Dec 2019

Longer than P75 for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
active not 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 Progress91%
Dec 2019Dec 2026

Study Start

First participant enrolled

December 16, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

7 years

First QC Date

December 17, 2019

Last Update Submit

January 5, 2026

Conditions

Ovarian CancerStage III Ovarian CancerStage IV Ovarian CancerPrimary Peritoneal CarcinomaFallopian Tube CarcinomaFallopian Tube Cancer

Keywords

Ovarian CancerPrimary peritoneal carcinomaFallopian tube cancer19-347Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Median completion of participants

    Study will be considered feasible if the cohort has a median completion of 70% or more

    Up to 1 year

Study Arms (1)

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)

Other: Prehabilitation

Interventions

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.

Participants with Ovarian Cancer

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

Preoperative Exercise

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 DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Theresa Gillis, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 19, 2019

Study Start

December 16, 2019

Primary Completion (Estimated)

December 16, 2026

Study Completion (Estimated)

December 16, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)