2031O - Randomized trial of a telephone-based weight loss intervention in overweight and obese patients (pts) with breast cancer (BC): The MEDEA trial

Background

Elevated Body Mass Index (BMI) is associated with inferior clinical outcomes, impaired quality of life (QOL), and increased cancer related fatigue (CRF) in pts with early BC. MEDEA evaluated the impact of a weight loss intervention on CRF in overweight or obese survivors of BC.

Methods

MEDEA (NCT04304924) is a French multicenter randomized trial. Pts with stage I-III BC within 12 months of primary treatment and BMI ≥25 kg/m² were eligible. MEDEA compared a telephone-based weight loss program delivered by a coach through 24 semi-structured calls over 12 months and focused on caloric restriction + education (intervention arm) with an education alone program (control arm). The intervention was adapted from the BWEL trial (A011401) and was considered completed if ≥16/24 calls were delivered. The primary endpoint was between-arm difference in CRF (EORTC C30) 12 months (M12) post-randomization, estimated by a linear mixed model. Secondary endpoints included weight, QOL (QLQ C30 / BR23), and satisfaction (Focus groups). The study had 80% power (two-sided α = 0.05) to detect an effect size of 0.40.

Results

220 pts were included. Mean (SD) age was 53.8 years (10.4), mean weight was 83.6 kg (14.0), and 65% of pts received endocrine therapy. At randomization, CRF scores were similar between arms (Mean [SD]: 40.2 [23.5] and 40.2 [27.8]). At M12, CRF was reduced by a mean of -7.8 points (SD 20.8) in the intervention and -2.0 points (SD 27.3) in the control arm. The estimated between arm difference at M12 was 5.9 (SE 3.7) but was not significantly different from zero (p=0.11). Mean and proportional weight loss at M12 was higher in the intervention arm vs control: -6.7 kg (SD 8.3), 10% vs -1.1 kg (SD 5.3), 1% (p_arm=0.025; p_arm*time=0.002). There was no detrimental effect on other QOL domains. Satisfaction and adherence to the intervention were high, with 75% completing ≥16/24 calls.

Conclusions

A telephone-based weight loss program did not lead to a significant difference in CRF at 12 months, but did induce significant weight loss among pts with BC. These results suggest a North American weight loss intervention was adaptable and could be disseminated in a different language and cultural context.

Clinical trial identification

NCT04304924; Release date: 20th March 2020.

Editorial acknowledgement

Legal entity responsible for the study

Gustave Roussy Cancer Center.

Funding

French National Cancer Institute (Institut National du Cancer [InCA]; grant RISP2018-13684.

Disclosure

I.V. Vaz Luis: Financial Interests, Personal, Other, Honoraria: Sandoz; Financial Interests, Institutional, Other, Honoraria: AstraZeneca, Amgen, Pfizer; Financial Interests, Institutional, Officer, Honoraria: Novartis; Financial Interests, Institutional, Research Funding: Resilience Care. A. Di Meglio: Financial Interests, Personal, Advisory Board: Kephren, Medycis, Techspert. O. Tredan: Financial Interests, Personal, Advisory Board: Roche, Pfizer, Novartis-Sandoz, Lilly, MSD, Astra-Zeneca, Pierre Fabre Oncologie, Seagen, Daiichi Sankyo, Gilead, Eisai, Stemline-Menarini. B. Pistilli: Financial Interests, Institutional, Advisory Board: AstraZeneca, Seagen, Lilly, Daiichi Sankyo, MSD; Financial Interests, Institutional, Invited Speaker: Gilead, Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre, Daiichi Sankyo; Financial Interests, Personal, Other, travel support: AstraZeneca, Pierre Fabre, MSD, Daiichi Sankyo; Financial Interests, Institutional, Steering Committee Member: AstraZeneca, Novartis; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Local PI: AstraZeneca, Gilead, Seagen, MSD, Novartis; Financial Interests, Institutional, Funding: Daiichi Sankyo; Non-Financial Interests, Project Lead: Unicancer. J. Bonastre: Financial Interests, Personal, Advisory Board, Scientific board: BMS, MSD, Janssen; Financial Interests, Institutional, Funding, Funding of the MICADO study: BMS. S. Michiels: Financial Interests, Personal, Other, Statistical advice: Roche; Financial Interests, Personal, Other, DSMB member: Sensorion, Servier, Biophytis, Yuhan, IQVIA, Kedrion. J. Ligibel: Non-Financial Interests, Institutional, Other, Product samples for a research project: Fitbit Corporation, Nestle Health Sciences. All other authors have declared no conflicts of interest.