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Prehabilitation Program for Advanced Ovarian Cancer

N/A

Recruiting

Led By Amanika A. Kumar, M.D.

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

Must not have

Hemiplegia or paraplegia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have paralysis on one side of my body or both legs.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Biospecimen Collection

2004

Completed Phase 3

~2020

Behavioral Counseling

2019