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Exercise for Ovarian and Endometrial Cancer Patients

N/A
Recruiting
Led By Christina Dieli-Conwright, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed patients with stages III-IV ovarian or endometrial cancer receiving first-line carboplatin and paclitaxel chemotherapy after surgery
Aged 18 years or older (children under 18 excluded due to rarity of disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial is testing whether a 16-week program of aerobic and resistance exercises, done at home with virtual supervision, is feasible for ovarian and endometrial cancer patients who are receiving first-line chemotherapy, and if it will improve leg function or reduce chemotherapy-induced numbness/tingling in the extremities.

Who is the study for?
This trial is for adults over 18 with stage III-IV ovarian or endometrial cancer who are starting first-line chemotherapy after surgery. They must be cleared by a doctor to do moderate-vigorous exercise, understand English, and consent to the study and blood draws. It's not for those with certain pre-existing conditions or uncontrolled illnesses that could affect participation.Check my eligibility
What is being tested?
The study tests if a 16-week virtual exercise program can help patients on chemotherapy improve leg function, reduce numbness in hands/feet from chemo (CIPN), and lower inflammation markers in the blood. Participants will either receive this exercise regimen or be part of an attention control group.See study design
What are the potential side effects?
While specific side effects aren't listed for exercising, potential risks may include muscle soreness, fatigue, joint pain, or exacerbation of existing health issues. The impact on inflammatory markers will also be monitored as it might indicate stress on the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have stage III-IV ovarian or endometrial cancer and am starting chemotherapy with carboplatin and paclitaxel after surgery.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Enrollment Rate
Proportion of patients completing the exercise intervention sessions.
Secondary outcome measures
Change in 6-minute walk distance
Number of Participants with Treatment Related Adverse Events
PROMIS- Physical function
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExerciseExperimental Treatment1 Intervention
Participants randomized to one of two groups with 2:1 ratio: exercise (n=20) - Aerobic and Resistance Exercise for 16 weeks
Group II: Attention ControlActive Control1 Intervention
Participants randomized to one of two groups with attention control (n=10). -Attention Control for 16 weeks home-based stretching

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,843 Total Patients Enrolled
39 Trials studying Ovarian Cancer
4,500 Patients Enrolled for Ovarian Cancer
Christina Dieli-Conwright, PhDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04997096 — N/A
Ovarian Cancer Research Study Groups: Exercise, Attention Control
Ovarian Cancer Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT04997096 — N/A
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04997096 — N/A

Frequently Asked Questions

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

How extensive is the enrollment for this clinical trial?

"Indeed, as evidenced by clinicaltrials.gov, this medical experiment is actively looking for participants. It was initially posted on April 2nd 2022 and last revised on May 4th 2022 with the aim of recruiting 30 people from 1 trial site."

Answered by AI

Are more participants being sought for this clinical experiment?

"According to the clinicaltrials.gov website, this medical experiment is actively enrolling patients into its study as of now. The trial was published on April 2nd 2022 and has been recently updated on May 4th 2022."

Answered by AI

What is the purpose behind this clinical experiment?

"This 16 week clinical trial will measure the proportion of participants who successfully complete their prescribed exercise regimen. Secondary objectives include tracking any Adverse Events (as defined by NCI's CTCAE version 5), assessing Physical Function through PROMIS-10, and analyzing changes in Aerobic Fitness via the 6 Minute Walk Test - a reliable measurement with an R2 coefficient of 0.93."

Answered by AI
~9 spots leftby Feb 2025