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High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women

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ClinicalTrials.gov Identifier: NCT03270111
Recruitment Status : Completed
First Posted : September 1, 2017
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center

Brief Summary:
The purpose of this second pilot study is to extend the feasibility demonstrated in NCT02963740 that the intervention achieves high levels of moderate to vigorous physical activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease in older, obese sedentary breast cancer survivors who are undergoing moderate calorie restriction.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Behavioral: Supervised Exercise Behavioral: Home-based Exercise Behavioral: Reduced Energy Diet Behavioral: Group Phone Calls Not Applicable

Detailed Description:
All subjects participate in same intervention. Intervention consists of a 6-month structured weight loss program utilizing portion controlled meals and a prescribed level of graduated physical activity with an eventual goal of 200 minutes or more per week. The program will include twice weekly sessions with a trainer at a local YMCA, and weekly phone group sessions the first 3 months with transition to unsupervised exercise and less frequent group phone sessions the second 3 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: High Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : July 24, 2018
Actual Study Completion Date : July 24, 2018


Arm Intervention/treatment
Experimental: A2: Breast Cancer Survivor
Participants will include breast cancer survivors who take part in a weight loss intervention program. The intervention is the same for all participants.
Behavioral: Supervised Exercise
Participants will take part in supervised exercise activities two times per week at a YMCA. Length of the activity will be increased during participation in study. Participants will start at 40 minutes per week and work their way up to 120 minutes per week.

Behavioral: Home-based Exercise
Aerobic exercise activities to be completed at home. Participants will be asked to start out doing 60 minutes at home and work up to 180 minutes of purposeful aerobic home exercise per week.

Behavioral: Reduced Energy Diet
Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.

Behavioral: Group Phone Calls
Sessions are weekly months 1-3 and every other week months 4-6. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating.

Experimental: B: High Risk Women
Participants will include women at high risk of breast cancer who take part in a weight loss intervention program. The intervention is the same for all participants.
Behavioral: Supervised Exercise
Participants will take part in supervised exercise activities two times per week at a YMCA. Length of the activity will be increased during participation in study. Participants will start at 40 minutes per week and work their way up to 120 minutes per week.

Behavioral: Home-based Exercise
Aerobic exercise activities to be completed at home. Participants will be asked to start out doing 60 minutes at home and work up to 180 minutes of purposeful aerobic home exercise per week.

Behavioral: Reduced Energy Diet
Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.

Behavioral: Group Phone Calls
Sessions are weekly months 1-3 and every other week months 4-6. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating.




Primary Outcome Measures :
  1. Adherence to supervised exercise sessions [ Time Frame: Week 12 ]
    Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.


Secondary Outcome Measures :
  1. Percent participants meeting physical activity goal [ Time Frame: Week 12 ]
    Measured as percentage of participants meeting final physical activity goal between week 9 to week 12. Measurement based off activity tracker participants will wear.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of breast cancer having completed any cytotoxic chemotherapy, radiation or surgery at least 3 months prior to study entry (Cohort A2) OR No prior diagnosis of breast cancer but at high risk for development of breast cancer and participating in HSC 4601 (Cohort B)
  • Body Mass Index (BMI) >30 kg/m2. Women with a BMI > 45 kg/m2 must be age < 60 and ability to perform physical activity must be confirmed
  • By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface
  • Possession of smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data accessed by study personnel
  • Access to a personal computer
  • Live in the greater Kansas City Metropolitan Area
  • Willing and able to perform moderate intensity exercise at least 5 days per week for 6 months. This consists of a supervised exercise intervention at one of the 15 YMCAs affiliated with our program for 2 days per week. Must be willing to perform unsupervised home exercise for the entire 6 months.
  • Willing to participate in a weekly behavioral modification group phone call for first 3 months and every 2 weeks for the second 3 months
  • Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal replacements plus 35 servings of fruits and vegetables/week for 6 months and track food intake and exercise
  • Blood tests (Cohort A2) must have been performed after completion of any breast cancer surgery, radiation therapy, or cytotoxic chemotherapy, with reasonably normal liver and renal function as well as a hemoglobin of 10 or higher and/or performed within a year of study entry

Exclusion Criteria:

  • Use of metformin, insulin, steroids or prescription weight loss or anti-psychotic drugs within the prior 3 weeks
  • Individuals with prior gastric bypass surgery or procedure that would impair absorption of nutrients
  • Need for chronic immunosuppressive drugs
  • Participation within the past 6 months on a structured weight loss program such as Weight Watchers®
  • Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week.
  • Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event
  • Currently receiving investigational agents in a clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270111


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Carol Fabian, MD
Investigators
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Principal Investigator: Carol Fabian, MD University of Kansas Medical Center

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Responsible Party: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03270111     History of Changes
Other Study ID Numbers: STUDY00141301
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carol Fabian, MD, University of Kansas Medical Center:
breast cancer survivor
weight loss program
Additional relevant MeSH terms:
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Breast Neoplasms
Weight Loss
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms