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

Primary Purpose

Breast Cancer Female

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supervised Exercise
Home-based Exercise
Reduced Energy Diet
Group Phone Calls
Sponsored by
Carol Fabian, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer Female focused on measuring breast cancer survivor, weight loss program

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A2: Breast Cancer Survivor

B: High Risk Women

Arm Description

Participants will include breast cancer survivors who take part in a weight loss intervention program. The intervention is the same for all participants.

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.

Outcomes

Primary Outcome Measures

Adherence to supervised exercise sessions
Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.

Secondary Outcome Measures

Percent participants meeting physical activity goal
Measured as percentage of participants meeting final physical activity goal between week 9 to week 12. Measurement based off activity tracker participants will wear.

Full Information

First Posted
August 30, 2017
Last Updated
January 9, 2022
Sponsor
Carol Fabian, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03270111
Brief Title
High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
Official Title
High Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
July 24, 2018 (Actual)
Study Completion Date
July 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carol Fabian, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
breast cancer survivor, weight loss program

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A2: Breast Cancer Survivor
Arm Type
Experimental
Arm Description
Participants will include breast cancer survivors who take part in a weight loss intervention program. The intervention is the same for all participants.
Arm Title
B: High Risk Women
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supervised Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home-based Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reduced Energy Diet
Intervention Description
Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.
Intervention Type
Behavioral
Intervention Name(s)
Group Phone Calls
Intervention Description
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 Measure Information:
Title
Adherence to supervised exercise sessions
Description
Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percent participants meeting physical activity goal
Description
Measured as percentage of participants meeting final physical activity goal between week 9 to week 12. Measurement based off activity tracker participants will wear.
Time Frame
Week 12

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Fabian, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34638355
Citation
Fabian CJ, Klemp JR, Marchello NJ, Vidoni ED, Sullivan DK, Nydegger JL, Phillips TA, Kreutzjans AL, Hendry B, Befort CA, Nye L, Powers KR, Hursting SD, Giles ED, Hamilton-Reeves JM, Li B, Kimler BF. Rapid Escalation of High-Volume Exercise during Caloric Restriction; Change in Visceral Adipose Tissue and Adipocytokines in Obese Sedentary Breast Cancer Survivors. Cancers (Basel). 2021 Sep 28;13(19):4871. doi: 10.3390/cancers13194871.
Results Reference
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High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women

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