Lifestyle, Exercise and Nutrition Study 2 (LEAN 2)

Not Applicable

Completed

• Conditions: Breast Cancer; Weight Loss
• Interventions: Behavioral: Weight Loss Counseling

• Registration Number: NCT02110641
• Lead Sponsor: Yale University

Brief Summary

The specific aims of this study are to determine the efficacy and cost-effectiveness of a weight loss program compared with usual care (control) treatment on 6-month changes in body weight, body fat, serum hormones, and breast tissue markers associated with prognosis in breast cancer survivors.

Detailed Description

We will conduct a two-armed study comparing a combination of an in-person and telephone weight loss program compared to usual care/wait list in 100 breast cancer survivors. Women will be randomized into one of the study arms using a random permuted block design. Research staff collecting body composition data, as well as reviewing forms and entering data, will be blinded to the participant's study group.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-10
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-17
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

Inclusion Criteria

• American Joint Committee on Cancer (AJCC) Stages 0-IIIC Breast Cancer
• BMI >25 kg/m2
• Completed surgery, chemotherapy and radiation at least 2 months ago
• Physically able to exercise
• Agrees to be randomly assigned to either weight loss or control
• Gives informed consent to participate in all study activities
• Able to come for baseline and 6-month clinic visits
• Mentally competent

Read More

Exclusion Criteria

• Patients with double mastectomy

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-Person or Telephone-Based Counseling	Weight Loss Counseling	The exact same information, content, schedule, and 30 minute sessions will be provided to telephone-based participants as offered to participants who receive in-person counseling. Participants will be taught diet, exercise and behavior change strategies via the telephone (weekly calls for month 1, every other week for months 2-3, and monthly for months 4-6). All lessons and diet and physical activity logs will be mailed to them at the beginning of the program. Participants will record their daily diet and exercise in the logs.

Primary Outcome Measures

Name	Time	Method
Change in body weight in kilograms (kg)	6 months	Participants will be weighed in light indoor clothing, without shoes, rounding up to the nearest 0.1 kg. All measures will be performed and recorded twice in succession.
Change in Body Mass Index (BMI)	6 months	BMI will be calculated using weight and height measurements (weight (kg)/height (m)\^2 ). Weight and height will be measured by research staff blinded to the participant's randomization group at baseline and 6-months. Participants will be weighed in light indoor clothing, without shoes, rounding up to the nearest 0.1 kg; height will be measured in a standard manner, without shoes, using a stadiometer, rounding up to the nearest 0.1 cm. All measures will be performed and recorded twice in succession.
Change in breast tissue markers	6 months	We will collect a breast tissue biopsy from the unaffected breast at baseline and 6 months. Six slides will be made from each specimen for immunohistochemistry, as follows: Ki67 (MIB-1, DAKO), IGF1 receptor (1D5; DAKO), insulin receptor (mouse anti-human monoclonal B1445; LifeSpan BioSciences), Estrogen receptor (SP1, NeoMarker), Progesterone receptor (pgR636, DAKO) and HER-2 neu (SP3, NeoMarker). Ki67 will be scored quantitatively (% positive nuclei) using the Aperio system (Specialized Histopathology Laboratory). Estrogen and progesterone receptors will be scored following current ASCO/CAP guidelines (percent positive, intensity). Her2 will be scored according to current ASCO/CAP guidelines (intensity of membrane staining). All other markers will be scored on a semi-quantitative scale (0 to 3+).
Change in percent body fat	6 months	Dual Energy X-Ray Absorptiometry (DEXA) scans will be performed at baseline and 6-months. The DEXA measurements will be made with a Hologic scanner (Hologic 4500 with a "Discovery" upgrade, Hologic Inc, Waltham, Mass). A whole-body scan takes approximately 10 minutes to complete. We will measure percent body fat utilizing DEXA.

Secondary Outcome Measures

Name	Time	Method
Change in fasting insulin	6 months	All the hormones to be measured (insulin, IGF-1, leptin, adiponectin and C-reactive protein) have been previously measured in our lab and published. We will use immunoassay techniques and kits from Diagnostic Products Corporation (DPC, Los Angeles, CA) to measure each hormone value. Each woman's baseline and follow-up samples will be used in the same batch, and an equal number of intervention and control samples will also be included in the same batch. Blind duplicates are also included in and between batches to estimate coefficient of variations.
Change in C-reactive protein	6 months	All the hormones to be measured (insulin, IGF-1, leptin, adiponectin and C-reactive protein) have been previously measured in our lab and published. We will use immunoassay techniques and kits from Diagnostic Products Corporation (DPC, Los Angeles, CA) to measure each hormone value. Each woman's baseline and follow-up samples will be used in the same batch, and an equal number of intervention and control samples will also be included in the same batch. Blind duplicates are also included in and between batches to estimate coefficient of variations.
Maintenance of Weight Loss	12 months	A mailed follow up will be conducted at 12-months post randomization. Questionnaires will be mailed to the participant with a pre-paid envelope for their return. Information about current weight will be collected using this method.
Changes in salivary cortisol	6 months	Women will be asked to collect 3 saliva samples (wake up, midday and bedtime) for 4 days following the baseline biopsy visit and 6 month follow up visit. Samples will be collected using Salivettes for cortisol. The cotton ball is removed from the Salivette, chewed for 1 minute and returned to the Salivette. Samples will be refrigerated in the container provided. Samples will be returned by mail in a specialized self-addressed pre-paid envelope when sample collection is complete.
Change in Leptin	6 months	All the hormones to be measured (insulin, IGF-1, leptin, adiponectin and C-reactive protein) have been previously measured in our lab and published. We will use immunoassay techniques and kits from Diagnostic Products Corporation (DPC, Los Angeles, CA) to measure each hormone value. Each woman's baseline and follow-up samples will be used in the same batch, and an equal number of intervention and control samples will also be included in the same batch. Blind duplicates are also included in and between batches to estimate coefficient of variations.
Skin Carotenoids Assessment	6 months	Assessment of skin carotenoids will be done using Resonance RAMAN Spectroscopy (RRS). Briefly, a small scanner which shines blue light is placed on the palm of the hand for 30 seconds. The palm is cleaned with an alcohol wipe prior to the scan, A RRS reading is available after a further 30 seconds. The procedure is repeated at the same body location. Skin color is self assessed by the participants at the baseline visit using samples that are used in plastic surgery to assess skin color. Melanin content (skin color) may have a small effect on RRS, but this effect is minimized by assessing skin carotenoids in the palm, which has a lower melanin content than other body sites.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States