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Behavioral Intervention
Intermittent Fasting for Breast Cancer Survivors with Obesity
N/A
Recruiting
Led By Victoria Catenacci, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-65 years
Be older than 18 years old
Must not have
Major surgery within the past 3 months (including mastectomy or breast reconstruction) or planned major surgery (including mastectomy or breast reconstruction) during the timeframe of the 6 month study intervention and follow-up phases
Uncontrolled hypertension, defined as diastolic blood pressure >100 mmHG, systolic blood pressure >160 mmHG, or resting heart rate >100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study the effects of intermittent fasting on weight loss in adults who have completed breast cancer treatment. Participants will follow a 3-month intermittent fasting program and increase physical activity. The study will
Who is the study for?
This trial is for adults who have finished breast cancer treatment, are overweight or obese, and want to try a weight loss program. Participants should be willing to follow an intermittent fasting plan with 3 modified fast days per week and increase physical activity.
What is being tested?
The study tests a 16-week weight loss intervention using intermittent fasting (4:3 paradigm) combined with support for increasing exercise to at least 150 minutes weekly. It aims to see how this affects body weight and adherence among participants post-cancer treatment.
What are the potential side effects?
Potential side effects may include hunger, fatigue, irritability or mood changes due to the fasting regimen. Physical activity might cause muscle soreness or strain in individuals not accustomed to regular exercise.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had major surgery in the last 3 months and do not plan any during the next 6 months.
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My blood pressure or heart rate is not higher than the limits given.
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I experience symptoms like chest pain or shortness of breath, suggesting heart issues.
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My daily activity is limited due to my health condition.
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I do not have serious heart rhythm problems.
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I do not plan to travel for more than 2 weeks in the next year.
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I am over 18 years old.
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My kidney function is severely reduced.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence to 4:3 Intermittent Fasting Dietary Paradigm as Measured by Food Records
Body Weight
Physical Activity
Secondary study objectives
Percent of Participants Completing Outcome Measures
Rate of Enrollment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Behavioral Weight Loss Focused on Intermittent FastingExperimental Treatment1 Intervention
3-month integrated behavioral weight loss intervention with a dietary focus on intermittent fasting.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Weight Loss
2008
Completed Phase 3
~1570
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,920,064 Total Patients Enrolled
29 Trials studying Breast Cancer
6,853 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,072 Total Patients Enrolled
942 Trials studying Breast Cancer
1,443,096 Patients Enrolled for Breast Cancer
National Insitutes of HealthUNKNOWN
Victoria Catenacci, MDPrincipal InvestigatorUniversity of Colorado, Denver
3 Previous Clinical Trials
447 Total Patients Enrolled