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Physical activity and/or dietary intervention in overweight or obese breast cancer survivors: results of the InForma randomized trial

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Abstract

Purpose

This study aimed to test the efficacy of a 6-month intervention on weight loss in a group of overweight or obese breast cancer (BC) survivors. We promoted adherence to a healthy diet or/and to increase physical activity, making use of a step counter device. Here we present results regarding the change in anthropometric measures and blood parameters.

Methods

266 women treated for BC with a BMI ≥ 25 kg/m2 were randomized to a 6-month intervention into four arms: Dietary Intervention (DI); Physical Activity Intervention (PAI); Physical Activity and Dietary Intervention (PADI); Minimal Intervention (MI). Women were offered individualized counseling by a dietitian, a physiotherapist and a psychologist. Participants were followed up for an additional 18 months.

Results

231 women completed the 6-month intervention and 167 completed the additional 18-month follow-up. Respectively, 37.5% and 36.7% of women included in the DI and PADI arm reached the objective of the trial (weight reduction > 5%). Significant weight and circumferences decrease was observed at 6-month in the four arms. Weight decrease was more pronounced in the DI (-4.7% ± 5.0%) and PADI (-3.9% ± 4.5%) arms, persisted over time (at 12 and 24 months), where counseling was mainly focused on the dietic component. The intervention had an effect on the glucose level with a significant reduction in whole population (-0.9 ± 11.7 p-value 0.02) and most pronounced in the PADI arm (-2.4 ± 7.8 p-value 0.03).

Conclusions

Lifestyle intervention mainly focused on the dietetic component and making use of a step counter improved body weight, circumferences and glucose levels.

Implications for Cancer Survivors

A personalized approach yields a potential clinical benefit for BC survivors.

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Data availability

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We would like to acknowledge and thank the participants who volunteered to take part, AKERN s.r.l for providing the disposable electrodes necessary for bioelectrical impedance measures during the trial, Allegramente Walking, ASD for providing support for physical activity interventions, William Russell-Edu for help with the literature and for editing the manuscript, and the association “La forza e il sorriso” for allowing us to host our groups in their meeting room (www.laforzaeilsorriso.it). We would also like to acknowledge and thank Sabina Sieri for help with nutritional assessment and Greta Pettini for help with the group meetings.

Funding

The trial is funded by the Associazione Italiana per la Ricerca sul Cancro (AIRC) (Grant n. 15963). This work was also partially supported by the Italian Ministry of Health with Ricerca Corrente and 5 × 1000 funds.

Author information

Authors and Affiliations

  1. Division of Epidemiology and Biostatistics, IEO European Institute of Oncology IRCSS, Via Ripamonti 435, 20141, Milan, Italy

    Patrizia Gnagnarella, Daniele Dragà, Silvia Raja, Marialetizia Latella & Patrick Maisonneuve

  2. Physiotherapy Unit, IEO European Institute of Oncology IRCSS, Via Ripamonti 435, 20141, Milan, Italy

    Federica Baggi & Maria Claudia Simoncini

  3. Dietetic and Clinical Nutrition Unit, IEO European Institute of Oncology IRCSS, Via Ripamonti 435, 20141, Milan, Italy

    Annarita Sabbatini

  4. Department of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, 20122, Milan, Italy

    Ketti Mazzocco, Marianna Masiero & Gabriella Pravettoni

  5. Applied Research Division for Cognitive and Psychological Sciences, IEO European Institute of Oncology IRCSS, Via Ripamonti 435, 20141, Milan, Italy

    Ketti Mazzocco, Marianna Masiero & Gabriella Pravettoni

  6. Division of Breast Surgery, IEO European Institute of Oncology IRCSS, Via Ripamonti 435, 20141, Milan, Italy

    Fabio Domenico Bassi & Nickolas Peradze

  7. Division of Laboratory Medicine, IEO European Institute of Oncology IRCSS, Via Ripamonti 435, 20141, Milan, Italy

    Laura Zorzino

Authors
  1. Patrizia Gnagnarella
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  2. Daniele Dragà
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  3. Silvia Raja
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  4. Federica Baggi
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  6. Annarita Sabbatini
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  14. Patrick Maisonneuve
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Contributions

PM: Study conception, Funding acquisition, Formal analysis, Writing—Review & Editing; PG: Study conception, Funding acquisition, Writing—Original Draft, Supervision; DD, SR, KM, MM GP: Investigation; FB, MCS, AS, GP: Methodology; FDB, NP, LZ: Supervision; ML: Writing—Review & Editing.

Corresponding author

Correspondence to Patrizia Gnagnarella.

Ethics declarations

Ethics approval

The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of the European Institute of Oncology (Reference number: n. R233/15 –IEO 244—Protocol version 3).

The trial has been registered at ClinicalTrials.gov (NCT02622711) and at the ISRCTN registry (ISRCTN53325751).

Consent to participate

All participants provided written informed consent.

Competing interests

The authors have no relevant financial or non-financial interests to disclose.

Conflict of interest

The authors declare no competing interests.

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Trial Registration: ISRCTN53325751; ClinicalTrials.gov NCT02622711.

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Gnagnarella, P., Dragà, D., Raja, S. et al. Physical activity and/or dietary intervention in overweight or obese breast cancer survivors: results of the InForma randomized trial. J Cancer Surviv (2023). https://doi.org/10.1007/s11764-023-01415-z

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