Lifestyle, Exercise and Nutrition Study 2 (LEAN 2)

NCT02110641 | Completed DMC

• 1 other identifier: 1012007780_1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Weight Loss

Keywords

Breast Cancer; Survivorship; Weight Loss

Outcome Measures

Primary Outcomes (4)

• Change in Body Mass Index (BMI)

  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.

  6 months

• Change in body weight in kilograms (kg)

  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.

  6 months

• Change in percent body fat

  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.

  6 months

• Change in breast tissue markers

  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+).

  6 months

Secondary Outcomes (6)

• Change in fasting insulin

  6 months

• Change in Leptin

  6 months

• Change in C-reactive protein

  6 months

• Skin Carotenoids Assessment

  6 months

• Maintenance of Weight Loss

  12 months

Other Outcomes (2)

• Change in Physical Activity

  6 months

• Change in Dietary Intake

  6 months

Study Arms (2)

In-Person or Telephone-Based Counseling

ACTIVE COMPARATOR

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.

Behavioral: Weight Loss Counseling

Usual Care/Wait List

NO INTERVENTION

At 6-months the participants in the Wait List group may choose to participate in the 11 sessions either in-person or via telephone or a combination of the two modes of delivery. They will also be offered the opportunity to return to Yale at 12-months (immediately after the end of the 6-month counseling sessions) to have weight and DEXA measured.

Interventions

Weight Loss Counseling BEHAVIORAL

The intervention will be based on the Diabetes Prevention Program weight loss program, which uses a combination of reduced caloric intake, increased physical activity, and behavior therapy. The content of the weight loss program will be similar for the in-person and telephone interventions, but the approach will vary (i.e., in-person vs. telephone counseling). The weight loss intervention will be conducted by a Registered Dietitian, who has training in exercise physiology and behavior modification.

In-Person or Telephone-Based Counseling

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with double mastectomy

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• Nguyen T, Irwin ML, Dewan AT, Cartmel B, Harrigan M, Ferrucci LM, Sanft T, Li F, Lu L, Salinas YD. Examining the effect of obesity-associated gene variants on breast cancer survivors in a randomized weight loss intervention. Breast Cancer Res Treat. 2021 Jun;187(2):487-497. doi: 10.1007/s10549-021-06151-5. Epub 2021 Mar 6.

  PMID: 33677781 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Weight Loss

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melinda L Irwin, PhD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 10, 2014
• Study Start: November 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

US (1)