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The LISA randomized trial of a weight loss intervention in postmenopausal breast cancer.

ABSTRACT: Obesity has been associated with poor breast cancer (BC) outcomes. We investigated whether a standardized, telephone-based weight loss lifestyle intervention in the adjuvant setting would impact BC outcomes. We conducted a multicenter trial randomizing women 1:1 to mail-based educational material alone (control) or combined with a standardized, telephone-based lifestyle intervention that focused on diet, physical activity, and behavior and involved 19 calls over 2 years to achieve up to 10% weight loss. In all, 338 (of 2150 planned) T1-3, N0-3, M0 hormone receptor positive BC patients with body mass index (BMI)??24?kg/m2 receiving adjuvant letrozole were randomized (enrolment ended due to funding loss). The primary outcome was disease-free survival (DFS); secondary outcome was Overall Survival (OS). At 8 years' median follow-up, in a planned analysis, DFS and OS were compared using the Kaplan-Meier method. Baseline BMI and other characteristics were similar between study arms. In all, 22 of 171 (12.9%) in the lifestyle intervention arm versus 30 of 167 (18.0%) in the education had DFS events; the hazard ratio (HR) was 0.71 (95% confidence interval [CI]: 0.41-1.24, p?=?0.23). Although loss of funding reduced sample size, we view these hypothesis generating results as compatible with our hypothesis of a potential beneficial effect of a lifestyle intervention on DFS. They provide support for completion of ongoing randomized controlled trials of the effect of lifestyle interventions in BC outcomes.

SUBMITTER: Goodwin PJ

PROVIDER: S-EPMC7035359 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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The LISA randomized trial of a weight loss intervention in postmenopausal breast cancer.

Goodwin Pamela J PJ Segal Roanne J RJ Vallis Michael M Ligibel Jennifer A JA Pond Gregory R GR Robidoux André A Findlay Brian B Gralow Julie R JR Mukherjee Som D SD Levine Mark M Pritchard Kathleen I KI

NPJ breast cancer 20200221

Obesity has been associated with poor breast cancer (BC) outcomes. We investigated whether a standardized, telephone-based weight loss lifestyle intervention in the adjuvant setting would impact BC outcomes. We conducted a multicenter trial randomizing women 1:1 to mail-based educational material alone (control) or combined with a standardized, telephone-based lifestyle intervention that focused on diet, physical activity, and behavior and involved 19 calls over 2 years to achieve up to 10% weig ...[more]

PMID: 32133391

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Project description:BACKGROUND:Certain eating behaviors are common among women with obesity. Whether these behaviors influence outcomes in weight loss programs, and whether such programs affect eating behaviors, is unclear. METHODS:Our aim was to examine the effect of baseline eating behaviors on intervention adherence and weight among postmenopausal women with overweight or obesity, and to assess intervention effects on eating behaviors. Four hundred and 39 women (BMI ?25?kg/m2) were randomized to 12?months of: i) dietary weight loss with a 10% weight loss goal ('diet'; n?=?118); ii) moderate-to-vigorous intensity aerobic exercise for 225 mins/week ('exercise'; n?=?117); iii) combined dietary weight loss and exercise ('diet + exercise'; n?=?117); or iv) no-lifestyle change control (n?=?87). At baseline and 12?months, restrained eating, uncontrolled eating, emotional eating and binge eating were measured by questionnaire; weight and body composition were assessed. The mean change in eating behavior scores and weight between baseline and 12?months in the diet, exercise, and diet + exercise arms were each compared to controls using the generalized estimating equation (GEE) modification of linear regression adjusted for age, baseline BMI, and race/ethnicity. RESULTS:Baseline restrained eating was positively associated with change in total calories and calories from fat during the dietary intervention but not with other measures of adherence. Higher baseline restrained eating was associated with greater 12-month reductions in weight, waist circumference, body fat and lean mass. Women randomized to dietary intervention had significant reductions in binge eating (-?23.7%, p?=?0.005 vs. control), uncontrolled eating (-?24.3%, p?<?0.001 vs. control), and emotional eating (-?31.7%, p?<?0.001 vs. control) scores, and a significant increase in restrained eating (+?60.6%, p?<?0.001 vs. control); women randomized to diet + exercise reported less uncontrolled eating (-?26.0%, p?<?0.001 vs. control) and emotional eating (-?22.0%, p?=?0.004 vs. control), and increased restrained eating (+?41.4%, p?<?0.001 vs. control). Women randomized to exercise alone had no significant change in eating behavior scores compared to controls. CONCLUSIONS:A dietary weight loss intervention helped women modify eating behaviors. Future research should investigate optimal behavioral weight loss interventions for women with both disordered eating and obesity. TRIAL REGISTRATION:NCT00470119 (https://clinicaltrials.gov). Retrospectively registered May 7, 2007.

Dataset Information

The LISA randomized trial of a weight loss intervention in postmenopausal breast cancer.

Publications

The LISA randomized trial of a weight loss intervention in postmenopausal breast cancer.

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