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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04267796
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Foundation for Women's Cancers
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Other: Aerobic Exercise Other: Dietary Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Resistance Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing Breast Cancer Risk Through Modifying Body Composition and Decreasing Inflammation in Normal Weight Women
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Group I (lifestyle intervention)
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.
Other: Aerobic Exercise
Complete aerobic training
Other Name: Aerobic Activity

Other: Dietary Intervention
Receive diet recommendations from health coach or registered dietitian
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Resistance Training
Complete high-resistance circuit training sessions
Other Name: Strength Training

Active Comparator: Group II (wait-list, lifestyle intervention)
Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.
Other: Aerobic Exercise
Complete aerobic training
Other Name: Aerobic Activity

Other: Dietary Intervention
Receive diet recommendations from health coach or registered dietitian
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Resistance Training
Complete high-resistance circuit training sessions
Other Name: Strength Training




Primary Outcome Measures :
  1. Evaluate the feasibility of a diet intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat. [ Time Frame: up to 16 weeks ]
    Will assessed by the calculated rates, frequencies, and 95% confidence intervals (CIs) for these measures

  2. Evaluate the exercise intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat. [ Time Frame: up to 16 weeks ]
    Will assessed by the calculated rates, frequencies, and 95% confidence intervals (CIs) for these measures



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Employee at MD Anderson Cancer Center
  • Age between 50-69 years old
  • Postmenopausal woman (absence of menstruation for at least one year, or history of bilateral oophorectomy)
  • Self-reported height and weight indicating a BMI of at least 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)
  • Not currently adhering to national physical activity guidelines (150 minutes per week of moderate intensity aerobic exercise or 75 minutes per week of vigorous intensity exercise, strength exercise twice a week)
  • 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 mass greater than or equal to 9.4 kg as indicated by a dual X-ray absorptiometry (DXA) scan
  • Height and weight indicating a BMI of at least 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

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): NCT04267796


Contacts
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Contact: Karen M. Basen-Engquist 713-745-3123 kbasenen@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Karen M. Basen-Engquist    713-745-3123      
Principal Investigator: Karen M. Basen-Engquist         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Foundation for Women's Cancers
Investigators
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Principal Investigator: Karen M Basen-Engquist M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04267796    
Other Study ID Numbers: 2019-0634
NCI-2019-07636 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-0634 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases