Reducing Breast Cancer Risk Through Modifying Body Composition and Decreasing Inflammation in Normal Weight Women

M.D. Anderson Cancer Center1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2021年6月25日最近更新: 2026年8月12日

适应症

干预措施

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: M.D. Anderson Cancer Center
入组人数: 40
试验地点: 1
主要终点: Evaluate the feasibility of a diet intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 50 Years 至 69 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Age 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 >= 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

排除标准

•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 (defined as: participants who complete more than 16 repetitions per exercise in their current resistance training regimen, or who don't find their last 1-2 reps to be difficult in their current regimen, or who increase the weight in their current routine).