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Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women

Primary Purpose

Breast Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
Dietary Intervention
Quality-of-Life Assessment
Questionnaire Administration
Resistance Training
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Carcinoma

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Employee at MD Anderson Cancer Center
  • Postmenopausal woman (absence of menstruation for at least one year, or history of bilateral oophorectomy)
  • Self-reported height and weight indicating a BMI >= 18.5 and < 25 kg/m^2
  • No contraindications to exercise (either no positive responses on the Physical Activity Readiness Questionnaire, or clearance from a health care provider certifying that the participant is healthy enough to exercise)
  • No history of invasive cancer, other than non-melanoma skin cancer
  • No history of renal disease
  • Able to walk without an assistive device
  • Not within 3 months of major surgery
  • Able to speak/read/write in English
  • Has internet access on a computer or mobile device
  • A trunk fat mass >= 9.4 kg as indicated by a dual x-ray absorptiometry (DXA) scan
  • Height and weight indicating a BMI of >= 18.5 and < 25 kg/m^2 verified at the screening visit

Exclusion Criteria:

  • MD Anderson employees that report to the principal investigator of this study
  • Participants that cannot engage in the exercise program for more than three weeks during the study period
  • Participants that are currently doing strength exercises that work all major muscle groups wo or more times per week

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (lifestyle intervention)

Group II (wait-list, lifestyle intervention)

Arm Description

Participants complete lifestyle intervention consisting of 1-3 sets of high-resistance circuit training sessions per week, up to 150 minutes of aerobic training per week, and diet recommendations from a health coach or registered dietitian twice per week for 16 weeks.

Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.

Outcomes

Primary Outcome Measures

Evaluate the feasibility of a diet intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.
Will assessed by the calculated rates, frequencies, and 95% confidence intervals (CIs) for these measures
Evaluate the exercise intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.
Will assessed by the calculated rates, frequencies, and 95% confidence intervals (CIs) for these measures

Secondary Outcome Measures

Full Information

First Posted
November 26, 2019
Last Updated
September 1, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI), Foundation for Women's Cancers
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1. Study Identification

Unique Protocol Identification Number
NCT04267796
Brief Title
Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women
Official Title
Reducing Breast Cancer Risk Through Modifying Body Composition and Decreasing Inflammation in Normal Weight Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI), Foundation for Women's Cancers

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
This trial studies how well a lifestyle intervention works in reducing breast cancer risk through changing body composition and decreasing inflammation in normal weight women. This trial may help researchers learn more about diet and exercise programs designed to decrease body fat in postmenopausal women who are of normal weight but have an elevated risk of breast cancer because of excess body fat.
Detailed Description
PRIMARY OBJECTIVE: I. Evaluate the feasibility of a diet and exercise intervention to decrease body fat in postmenopausal women with normal body mass index (BMI) but high body fat (trunk fat mass 9.4 kg, the 50th percentile of normal BMI women in the Women's Health Initiative [WHI]). SECONDARY OBJECTIVE: I. Assess preliminary efficacy of the intervention by evaluating the post-intervention differences between the intervention and control groups in: IIa. Circulating markers of inflammation and metabolic dysfunction linked to both excess adiposity and breast cancer (high sensitivity C-reactive protein [hsCRP], fasting insulin, leptin, IL-6, triglycerides, sex hormone binding globulin [SHBG], adiponectin, and high density lipoprotein [HDL] cholesterol). IIb. Body composition body fat, trunk fat mass, fat mass, lean mass, fat-free mass). EXPLORATORY OBJECTIVE: I. Exploratory outcomes include fitness (oxygen consumption VO2 peak, sit-to-stand test), behavior (physical activity, energy intake, macronutrient consumption), and quality of life (global health-related quality of life, physical functioning, sleep, menopausal symptoms). OUTLINE: Participants are randomized to 1 of 2 groups. GROUP I: Participants complete lifestyle intervention consisting of 1-3 sets of high-resistance circuit training sessions per week, up to 150 minutes of aerobic training per week, and diet recommendations from a health coach or registered dietitian twice per week for 16 weeks. GROUP II: Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (lifestyle intervention)
Arm Type
Experimental
Arm Description
Participants complete lifestyle intervention consisting of 1-3 sets of high-resistance circuit training sessions per week, up to 150 minutes of aerobic training per week, and diet recommendations from a health coach or registered dietitian twice per week for 16 weeks.
Arm Title
Group II (wait-list, lifestyle intervention)
Arm Type
Active Comparator
Arm Description
Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Other Intervention Name(s)
Aerobic Activity
Intervention Description
Complete aerobic training
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Receive diet recommendations from health coach or registered dietitian
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Resistance Training
Other Intervention Name(s)
Strength Training
Intervention Description
Complete high-resistance circuit training sessions
Primary Outcome Measure Information:
Title
Evaluate the feasibility of a diet intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.
Description
Will assessed by the calculated rates, frequencies, and 95% confidence intervals (CIs) for these measures
Time Frame
up to 16 weeks
Title
Evaluate the exercise intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.
Description
Will assessed by the calculated rates, frequencies, and 95% confidence intervals (CIs) for these measures
Time Frame
up to 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Employee at MD Anderson Cancer Center Postmenopausal woman (absence of menstruation for at least one year, or history of bilateral oophorectomy) Self-reported height and weight indicating a BMI >= 18.5 and < 25 kg/m^2 No contraindications to exercise (either no positive responses on the Physical Activity Readiness Questionnaire, or clearance from a health care provider certifying that the participant is healthy enough to exercise) No history of invasive cancer, other than non-melanoma skin cancer No history of renal disease Able to walk without an assistive device Not within 3 months of major surgery Able to speak/read/write in English Has internet access on a computer or mobile device A trunk fat mass >= 9.4 kg as indicated by a dual x-ray absorptiometry (DXA) scan Height and weight indicating a BMI of >= 18.5 and < 25 kg/m^2 verified at the screening visit Exclusion Criteria: MD Anderson employees that report to the principal investigator of this study Participants that cannot engage in the exercise program for more than three weeks during the study period Participants that are currently doing strength exercises that work all major muscle groups wo or more times per week
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen M. Basen-Engquist
Phone
713-745-3123
Email
kbasenen@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen M Basen-Engquist
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen M. Basen-Engquist
Phone
713-745-3123
First Name & Middle Initial & Last Name & Degree
Karen M. Basen-Engquist

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women

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