Clinical trial NCT01874184: Group-Based Lifestyle Intervention in Measuring Biomarker Levels in Participants at High Risk for Breast Cancer
Official title: Diet, Exercise and Estrogen Metabolites Study (DEEM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atypical Ductal Breast Hyperplasia
Atypical Lobular Breast Hyperplasia
BRCA1 Mutation Carrier
BRCA2 Mutation Carrier
Ductal Breast Carcinoma in Situ
Lobular Breast Carcinoma in Situ
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute of Nursing Research (NINR)
First posted: 2013-06-10
Enrollment: 17
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This randomized clinical trial studies a group-based lifestyle intervention or usual care in measuring biomarker levels in participants at high risk for breast cancer. Studying the effects that changes to daily eating and exercise habits can have on the body's hormone levels and the body's ability to activate proteins may help doctors identify interventions for individuals at high risk for breast cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To calculate eligibility rates, participation rates, retention, and adherence within the Diet, Exercise and Estrogen Metabolites (DEEM) study.

II. To determine inter- and intra-person variability of the estrogen-deoxyribonucleic acid (DNA) adducts (EDA) biomarkers in participants of the DFS.

III. To explore the effects of the intervention on percent adiposity and the EDA ratio at the end of the 3-month intervention and 6-month follow-up.

SECONDARY OBJECTIVES:

I. To explore the effects of the intervention on the DNA damage repair (DDR) biomarker at 3-months.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants take part in weekly 2-hour group counseling sessions for 6 months with taper beginning at 3 months. Group sessions include education, group process, and experiential learning on the benefits of physical activity, balanced nutrition, and mindfulness techniques. Participants set goals for changing their dietary habits with the help of a mental health counselor and are also encouraged to exercise 3-4 times per week, including experiential group activities such as brisk walking, yoga, Zumba, and group fitness.

ARM II: Participants receive their usual care and are also provided with study materials on healthy diet and exercise at the end of the study.

After completion of study, participants are followed up for 3 months.

Eligibility criteria: Inclusion Criteria:

* Women will be considered at high risk for developing breast cancer if they fulfill one of the following criteria:

  * A Gail model risk of \>= 1.7% over 5
  * Claus model lifetime risk of \> 20%
  * Tyrer-Cuzick model lifetime risk \> 20%
  * Personal history of breast biopsy showing atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS)
  * Ductal carcinoma in situ (DCIS) that has been previously treated; patients must be at least 2 months from completion of primary therapy not currently on hormonal therapy
  * Deleterious mutation in breast cancer (BRCA)1 or BRCA2 another gene known to increase the risk of developing breast cancer
  * Risk assessment of 20% chance or greater of carrying a BRCA1/2 gene mutation; the BRCAPRO model will be used to assess this risk
* Body mass index (BMI)

  * For postmenopausal women: a BMI of \> 28 and \< 40
  * For premenopausal women: a BMI of \> 25 and \< 40
* Willingness to provide informed consent
* Physically able to undertake a moderate exercise program (assessed at the clinic visit)
* Participant has the ability to attend weekly group counseling sessions and subsequent clinic visits
* Participant has the ability to communicate in English
* Participant agrees to be randomly assigned

Exclusion Criteria:

* Women who are currently engaged in more than 90 min of moderate to vigorous exercise per week at the time of recruitment
* Alcohol/drug abuse or significant mental illness, as assessed by study personnel
* Previous diagnosis of invasive cancer within the past 5 years (in situ breast cancer and simple basal or squamous cell carcinoma not included)
* Plans to leave the geographic area within six months
* Contraindications for treadmill testing or entry into a training program
* Pregnant women or women planning to be pregnant in the following year will not be admitted in to the study

Primary outcomes:
measure: Level of adherence to the dietary component evaluated using the 3-day food records
timeFrame: Up to 9 months
measure: Level of adherence to the exercise component evaluated using the physical activity logs
timeFrame: Up to 9 months
measure: Level of adherence to the group counseling sessions component evaluated by tracking attendance
timeFrame: Up to 9 months
measure: Inter-person variability
timeFrame: Up to 3 months
measure: Change in EDA biomarker levels
timeFrame: Baseline to up to 6 months
measure: Change in BMI
timeFrame: Baseline to up to 6 months
measure: Change in percentage of total fat
timeFrame: Baseline to up to 6 months
measure: Change in percentage of body fat as measured by BMI
timeFrame: Baseline to up to 6 months
measure: Movement through the stages of change (pre-contemplation, contemplation, action, and maintenance) and data collected from quality of life questionnaires
timeFrame: Up to 9 months
Secondary outcomes:
measure: Differences in change of the DNA repair assay in intervention participants versus controls
timeFrame: Baseline to up to 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
name: Kerryn Reding
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stone SA, Han CJ, Senn T, Korde LA, Allott K, Reding S, Whittington D, Reding KW. Sex Hormones in Women With Elevated Breast Cancer Risk Undergoing Weight Loss. West J Nurs Res. 2019 Nov;41(11):1602-1622. doi: 10.1177/0193945918820672. Epub 2019 Jan 7.