Feasibility of an exercise and nutritional intervention for weight management during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial
Lack of physical activity (PA), weight gain, and overweight have been associated with increased risk of recurrence and mortality after breast cancer diagnosis. We evaluated the feasibility of implementing an individualized exercise program and nutritional counseling during adjuvant treatment of localized invasive breast cancer.
Sixty-one patients eligible for adjuvant chemotherapy were randomized 2:1 to receive a 6-month program of weekly aerobic exercises associated with nutritional counseling (n = 41) or usual care with nutritional counseling (n = 20, one withdrawal). The primary endpoints were the proportion of patients compliant with two weekly supervised sessions and their overall adherence (i.e., proportion of supervised and unsupervised sessions completed versus planned sessions).
Ten percent of patients in the intervention group were compliant with the two weekly supervised sessions for 6 months, but the overall median adherence rate was 85% of supervised and non-supervised sessions completed. Non-adherence was mainly due to intrinsic reasons (medical, organizational, psychological barriers). Adherence was positively associated with education and baseline PA level and inversely associated with baseline weight and tumor grade. No statistically significant benefits were observed in the intervention group, even if overall PA level and body composition improved and anthropometrics were maintained over time (p < 0.05).
Overall, there was good adherence with the 6-month exercise program during adjuvant treatment for breast cancer, despite poor compliance to twice-weekly supervised sessions. This study highlights the need for flexible exercise modalities and innovative experimental design to reach patients who would most adhere and benefit from intervention.
Trial registration: ClinicalTrials.gov Identifier: NCT01331772. Registered 8 April 2011, https://clinicaltrials.gov/ct2/show/NCT01331772?term=pasapas&rank=1
KeywordsBreast cancer Physical activity Exercise Clinical trial Nutrition Obesity
percentage of body fat
adapted physical activity
body mass index
daily energy expenditure
fat free mass
metabolic equivalent of task
The authors thank all the study participants for their valuable voluntary contribution. The authors thank Dr. Jean-Paul Guastalla (Center Léon Bérard, Lyon, France) for his collaboration in recruiting patients in the study. The authors also thank Margaret Haugh (MediCom Consult, Villeurbanne, France) for language editing and editorial support.
AMF, ASKL, CB, RM, SG, VBB, DP, SB, ER, LP, PB, BF, OT, and MT contributed to conception and design of the trial. PB, BF, and OT were principal investigators. PR, PEH, TB, and OT were investigators. AMF, ASKL, CB, RM, SG, SM, VBB, EG, JC, SB, ER, PB, BF, OT, and MT acquired the data. MM and SC analyzed the data. AMF, MM, SB, PB, BF, OT, and MT participated in the interpretation of the findings. AMF, MM, BF, and MT drafted the manuscript. All of the authors read and approved the final manuscript.
This PASAPAS trial was supported by the Institut National du Cancer (2010-228/VO-HO), Ligue Contre le Cancer (PME 2010-2011), Fondation de France (2010-15024), Cancéropôle Lyon Auvergne Rhône-Alpes (CLARA Programme structurant 2010), and Association Nationale de la Recherche et de la Technologie (CIFRE/ANRT no. 426/2010).
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
The study was approved by the French Sud-Est IV ethics committee (Comité de Protection des Personnes), the National Security Agency of Medicines and Health Products that applies for biomedical studies (Agence Nationale de Sécurité du Médicament et des produits de santé), and the French National Committee on Informatics and Privacy (Commission Nationale de l’Informatique et des Libertés).
Informed consent was obtained from all individual participants included in the study.
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