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Walking Exercise for Breast Cancer
N/A
Recruiting
Led By Stephen Anton
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Completed adjuvant therapy for at least 3 months but no more than 1 year
Had at least moderate-level fatigue (defined as raw score ≥ 8 on the PROMIS Measure)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 8
Awards & highlights
Study Summary
This trial will investigate how walking exercise can reduce fatigue in older breast cancer survivors.
Who is the study for?
This trial is for older breast cancer survivors, aged 60 or above, who finished their cancer therapy between 3 months and a year ago. Participants must have had stage I-III invasive breast cancer diagnosed in 2021 or 2022 and be experiencing moderate to severe fatigue. They should not have any major health issues that could interfere with exercise.Check my eligibility
What is being tested?
The EXERGISE study is testing whether walking exercises can help reduce fatigue in older breast cancer survivors. It compares two types of walking programs: one that's done at a center under supervision and another that participants can do at home on their own.See study design
What are the potential side effects?
Walking exercises are generally safe but may include muscle soreness, joint pain, or increased fatigue initially. Since the program is designed for older adults who've had cancer treatment, it aims to minimize strain while improving stamina.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I finished my additional cancer treatment between 3 months and 1 year ago.
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I often feel very tired.
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I am 60 years old or older.
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I had early to locally advanced breast cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Self-Reported Fatigue
Secondary outcome measures
Dispositional Gratitude
Functional Assessment of Cancer Therapy - Breast (FACT-B)
Gait Speed
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Home-Based Walking ExerciseExperimental Treatment1 Intervention
Subjects will be randomly assigned to walk for exercise in their community five days/week.
Group II: Center-Based Walking ExerciseExperimental Treatment1 Intervention
Subjects will be randomly assigned to receive a center-based walking exercise intervention 3 days per week for the duration of the study.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,681 Total Patients Enrolled
7 Trials studying Fatigue
494 Patients Enrolled for Fatigue
Stephen AntonPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
118 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have other health problems that could make it difficult for you to take part in the exercise program.I have not taken any probiotics in the last 4 weeks.You drink more than 14 drinks a week, or you drink more than 5 drinks a day if you are male, or more than 4 drinks a day if you are female.I haven't taken any antibiotics in the last 4 weeks.My condition is a worsening nerve disease.I finished my additional cancer treatment between 3 months and 1 year ago.I have not had hip, knee, or spinal surgery in the last 4 months.You have used drugs or alcohol excessively in the last 3 years.I have been diagnosed with a heart or lung condition, arthritis, diabetes, or kidney disease in the last 3 years.I often feel very tired.You have a positive test for harmful bacteria in your stool, like Clostridium difficile.Your cancer was diagnosed in 2021 or 2022.I am 60 years old or older.You have smoked within the last 3 years.I had early to locally advanced breast cancer.I have been treated for HIV, hepatitis B, or hepatitis C.I regularly take nicotinamide riboside supplements.I am currently in a rehabilitation program.You have major problems with thinking and memory.You have medical reasons that make it unsafe for you to participate in exercise training.I experience little to no fatigue.
Research Study Groups:
This trial has the following groups:- Group 1: Center-Based Walking Exercise
- Group 2: Home-Based Walking Exercise
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 persons under the age of 80 admissible for this experiment?
"The age requirements for those wishing to participate in this trial is between 60 and 105. In comparison, there are 87 trials open to minors while 2,693 studies have been established that accept participants aged 65 or above."
Answered by AI
Is there an open enrollment for this clinical trial?
"According to clinicaltrials.gov, this medical trial has reached its recruitment limit and is not currently enrolling patients. Although it was initially posted on March 1st 2023, with its last update occurring on December 1st 2023, there are a plethora of other trials actively accepting participants at the moment - 2826 in total!"
Answered by AI
Is it possible for me to partake in this experiment?
"For this medical trial, 24 eligible candidates are sought-after; they must be between 60 and 105 years of age. Furthermore, applicants should demonstrate a willingness to take part in all study procedures, have been diagnosed with stage I-III invasive breast cancer within 2021 or 2022 timeframe, finalized adjuvant therapy at least 3 months ago but no more than 1 year back, and present moderate fatigue (as indicated by raw score ≥ 8 on the PROMIS Measure)."
Answered by AI
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