Breast Carcinoma
Conditions
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.
Interventions
OTHERAerobic Exercise
Complete aerobic training
OTHERDietary Intervention
Receive diet recommendations from health coach or registered dietitian
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
OTHERResistance Training
Complete high-resistance circuit training sessions
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Foundation for Women's Cancers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
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 (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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eligibility Rate | 4 months | Eligibility rate will be calculated as the number of eligible women identified divided by the total number completing a DXA scan. Criteria for feasibility will be defined as an eligibility rate of ≥ 40% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Adherence | 4 months | Intervention adherence for an individual is defined as attending at least 22 of the sessions with the personal trainer and at least 11 of the health coaching sessions. The intervention adherence at the study level is then defined by the percentage of participants adhering to the intervention. Criteria for feasibility will be defined as a study intervention adherence rate of ≥ 75% |
| Retention Rate | 8 months | Retention will be assessed by the percentage of participants completing the 4-month study assessments. Criteria for feasibility will be defined as a retention rate of ≥ 80% in each arm. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKaren M Basen-Engquist
M.D. Anderson Cancer Center
Participant flow
Recruitment details
Participants were recruited between June 2021-December 2024; participants were enrolled from both the general population and from the MD Anderson employee pool via email blast.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
None listed