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Prehabilitation Program for Advanced Ovarian Cancer

N/A

Recruiting

Led By Amanika Kumar, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Curative intent treatment with platinum-based chemotherapy

Suspected Stage IIIC or IV disease based on clinician staging and imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 months

Awards & highlights

Study Summary

This trial is testing a new program to help women with ovarian cancer who are undergoing neoadjuvant chemotherapy. The program is designed to improve their physical state before surgery and thus improve outcomes.

Who is the study for?

This trial is for English-reading adults over 18 with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. They should be able to use technology and consent to participate. It's not for those who are pregnant or have hemiplegia/paraplegia.Check my eligibility

What is being tested?

The study tests a prehabilitation program combining behavioral counseling, nutritional supplements, and physical activity started during chemotherapy to see if it helps recovery after surgery for certain cancers.See study design

What are the potential side effects?

Potential side effects may include discomfort from increased physical activity, possible digestive changes due to the nutritional supplement drink, and emotional responses related to behavioral counseling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated with platinum-based chemotherapy aiming for a cure.

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My cancer is suspected to be in an advanced stage.

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I am 18 years old or older.

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I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to each prehabilitation component based on patient reported adherence (Cohorts 2 & 3)

Secondary outcome measures

Acceptability of remote setting in Cohort 3

Change of Short Physical Performance Battery (SPPB) over time in cohort 2

Correlation of Short Physical Performance Battery (SPPB) to other assessments in cohorts 1 and 2

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3 (exercise, supplement, coaching, Resilient Living)Experimental Treatment6 Interventions

Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study.

Group II: Cohort 2 (exercise, supplement, Resilient Living)Experimental Treatment5 Interventions

Patients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial.

Group III: Cohort 1 (surveys, CT, blood samples)Experimental Treatment3 Interventions

Patients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Biospecimen Collection

2004

Completed Phase 2

~1700

Health Education

2014

Completed Phase 3

~4010

Behavioral Counseling

2019

Completed Phase 4

~650

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,210 Previous Clinical Trials

3,766,873 Total Patients Enrolled

10 Trials studying Ovarian Cancer

3,508 Patients Enrolled for Ovarian Cancer

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,906 Total Patients Enrolled

286 Trials studying Ovarian Cancer

73,766 Patients Enrolled for Ovarian Cancer

Amanika Kumar, MDPrincipal InvestigatorMayo Clinic

Media Library

Exercise - Physical Activity Clinical Trial Eligibility Overview. Trial Name: NCT05047926 — N/A

Ovarian Cancer Research Study Groups: Cohort 1 (surveys, CT, blood samples), Cohort 3 (exercise, supplement, coaching, Resilient Living), Cohort 2 (exercise, supplement, Resilient Living)

Ovarian Cancer Clinical Trial 2023: Exercise - Physical Activity Highlights & Side Effects. Trial Name: NCT05047926 — N/A

Exercise - Physical Activity 2023 Treatment Timeline for Medical Study. Trial Name: NCT05047926 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the doors still open to join this investigation?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, which was initially publicized on October 1st 2021, is still recruiting patients for enrollment. 60 individuals are currently needed from a single medical centre."

Answered by AI

What is the cut-off for enrolment in this experiment?

"Affirmative. According to clinicaltrials.gov, this experiment is currently enlisting volunteers; it was initially posted on October 1st 2021 and most recently revised July 15th 2022. Sixty individuals are needed for the trial across one medical facility."

Answered by AI

What are the main aims of this experiment?

"This 9-week clinical trial will measure the participants' compliance with nutritional guidelines. Secondary outcomes evaluated over that same period include shifts in SPPB, as well as changes to Short Physical Performance Battery scores pre-operatively and post-treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients

Amanika Kumar, M.D. 2021. "Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05047926.

All > Peritoneal Carcinomatosis