Your session is about to expire
← Back to Search
Exercise for Cancer-Related Fatigue in Breast Cancer
N/A
Waitlist Available
Led By Brett Lewis, M.D., Ph.D
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Sedentary activity level at baseline, defined by less than 60 minutes per week of modest physical activity based on 7-day physical activity recall questionnaire
Radiation therapy naïve
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks into rt, 4 week follow up visit
Awards & highlights
Study Summary
This trial is testing whether exercise can help relieve fatigue in people undergoing radiation therapy for cancer.
Who is the study for?
This trial is for women aged 18-75 with non-metastatic breast cancer who are not currently pregnant or planning to become so, and have been sedentary. They must be about to start radiation therapy but can't be on chemotherapy or have had previous chest radiotherapy. A doctor's approval and a negative pregnancy test are needed.Check my eligibility
What is being tested?
The study tests if moderate exercise for 15 minutes at a time can reduce fatigue caused by radiation therapy in breast cancer patients. The goal is to determine whether future recommendations should include exercise during treatment.See study design
What are the potential side effects?
Since the intervention involves moderate exercise, potential side effects may include muscle soreness, joint pain, or increased fatigue initially as the body adjusts to new activity levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do less than 60 minutes of moderate exercise per week.
Select...
I have never undergone radiation therapy.
Select...
I am a woman aged between 18 and 75.
Select...
My breast cancer is confirmed and has not spread beyond the breast.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 weeks into rt, 4 week follow up visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks into rt, 4 week follow up visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of change in blood biomarker of inflammation: Ferritin
Assessment of change in blood biomarker of inflammation: High sensitivity CRP (hsCRP)
Assessment of change in blood biomarker of inflammation: Serum fibrinogen
+2 moreSecondary outcome measures
Assessment of change in Cancer-related healthcare quality of life (HRQOL) measured using the Functional Assessment of Cancer Therapy (FACT) system questionnaires.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Moderate ExerciseExperimental Treatment1 Intervention
Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week).
Group II: Control GroupActive Control1 Intervention
No exercise
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,220 Total Patients Enrolled
3 Trials studying Fatigue
308 Patients Enrolled for Fatigue
Lombardi Comprehensive Cancer CenterOTHER
6 Previous Clinical Trials
1,130 Total Patients Enrolled
Brett Lewis, M.D., Ph.DPrincipal InvestigatorHackensack UMC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do less than 60 minutes of moderate exercise per week.I am either younger than 18 or older than 75.My breast cancer has not been confirmed by tissue analysis.I have had radiotherapy to my breast, chest, or pelvic area before.My cancer has spread to distant parts of my body.I can walk on my own without help.I am currently receiving chemotherapy.I have never undergone radiation therapy.I am a woman aged between 18 and 75.My breast cancer is confirmed and has not spread beyond the breast.
Research Study Groups:
This trial has the following groups:- Group 1: Moderate Exercise
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining vacancies to join this medical experiment?
"As stated on clinicaltrials.gov, the recruitment of participants for this trial has been suspended; it was initially posted on June 21st 2016 and last updated September 2nd 2022. Nevertheless, there are still 212 other trials looking to enrol patients at present."
Answered by AI
Would I be eligible to participate in this research project?
"This study requires 24 participants, aged 18 to 75, who suffer from fatigue. Qualifying patients must have non-metastatic breast cancer (invasive or in situ) and be deemed medically fit for the trial by their physician. Additionally, they must complete a PAR-Q questionnaire regarding potential physical impediments that might hinder participation in an exercise programme as well as a 7 day physical activity recall survey which would demonstrate below average levels of ambulatory movement. Furthermore, all interested parties need to pass a pregnancy test and not plan on conceiving during the duration of the experiment prior to being randomized into it. Lastly, meaningful consent is needed before"
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger