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Exercise Program for Breast Cancer Fatigue

Q: Are there any vacancies available to participate in this trial?

<p>Confirmed. The trial, which commenced on December 22nd 2022 is currently enrolling participants and was recently updated on January 19th 2023 as per clinicaltrials.gov.</p>

Q: How many participants have been recruited to participate in this investigation?

<p>Affirmative. According to the records available on clinicaltrials.gov, this trial has been actively recruiting patients since its initial posting on December 22nd 2022 and was last updated January 19th 2023. Forty individuals need to be recruited from 1 medical facility for completion of the study.</p>

N/A

Recruiting

Led By Priya P Gor, MD, MSCE

Research Sponsored by Virtua Health, Inc.

Eligibility Criteria Checklist

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

Must have

ECOG performance score < 3

Age > 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6 following completion of chemotherapy

Awards & highlights

Study Summary

This trial tests how home exercise can reduce fatigue in people with breast cancer receiving chemotherapy. Subjects use a mobile device to report outcomes weekly.

Who is the study for?

This trial is for English-speaking women over 18 with breast cancer, planning to undergo at least 4 chemotherapy cycles. They must be able to exercise (if cleared by a cardiologist), have an ECOG score <3, and own a device like a smartphone for reporting. It's not for those with exercise contraindications or certain medical/psychiatric conditions.Check my eligibility

What is being tested?

The study tests if home exercises can reduce fatigue in breast cancer patients during chemotherapy. Participants are randomly assigned to either control (no exercise) or intervention (exercise) groups, and they report their fatigue levels using specific tools online throughout the treatment period.See study design

What are the potential side effects?

Since this trial involves an exercise program rather than medication, side effects may include typical physical responses to exercise such as muscle soreness or strain especially when starting new routines or increasing intensity.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but may not be able to do heavy physical work.

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I am older than 18 years.

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I am a woman planning to undergo at least 4 chemotherapy cycles for breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6 following completion of chemotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6 following completion of chemotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 following completion of chemotherapy for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.

Secondary outcome measures

To quantify the change over time in PRO-CTCAE derived symptoms

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExerciseExperimental Treatment1 Intervention

Intervention: Subject will be assessed by a Physical Therapist. Based on the assessment, the Physical Therapist will provide the patient with a home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. Patients will be asked to complete a symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.

Group II: ControlActive Control1 Intervention

Subject will not be provided an exercise program but will be asked to complete the symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~760

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Virtua Health, Inc.Lead Sponsor

8 Previous Clinical Trials

626 Total Patients Enrolled

Carevive Systems, Inc.Industry Sponsor

15 Previous Clinical Trials

1,014 Total Patients Enrolled

5 Trials studying Breast Cancer

226 Patients Enrolled for Breast Cancer

Priya P Gor, MD, MSCEPrincipal InvestigatorPenn Medicine

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05704842 — N/A

Breast Cancer Research Study Groups: Exercise, Control

Breast Cancer Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT05704842 — N/A

Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05704842 — N/A

Frequently Asked Questions

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

Are there any vacancies available to participate in this trial?

"Confirmed. The trial, which commenced on December 22nd 2022 is currently enrolling participants and was recently updated on January 19th 2023 as per clinicaltrials.gov."

Answered by AI

How many participants have been recruited to participate in this investigation?

"Affirmative. According to the records available on clinicaltrials.gov, this trial has been actively recruiting patients since its initial posting on December 22nd 2022 and was last updated January 19th 2023. Forty individuals need to be recruited from 1 medical facility for completion of the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluate Impact of Exercise Program on Fatigue in Breast Cancer During Chemotherapy

2022. "Evaluate Impact of Exercise Program on Fatigue in Breast Cancer During Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05704842.