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A randomised trial evaluating dietary and osteopathic techniques on quality of life and modulation of the inflammatory state in patients under antiestrogenic hormonal treatment after breast surgery
Ferraris, C. [1]
Listorti, C. [1]
Vernieri, C. [1]
Capri, G. [1]
Bianchi, G. [4]
Fucà, G. [1]
Ligorio, F. [1]
Martelli, G. [1]
Pilotta, F. [1]
Osio, C. [1]
Maugeri, I. [1]
Venturelli, E. [1]
Borreani, C. [1]
Alfieri, S. [1]
Folli, S. [1]
Miceli, A. [1]

Journal: European Journal of Surgical Oncology Date: 2024/02, 50(2):Pages: 107320. doi: Subito , type of study: pretest posttest design


Keywords:

antiestrogen hormonal treatment [1]
breast cancer [14]
breast surgery [1]
pre-menopausal women [1]
post-menopausal women [1]
quality of life [86]
OMT [2951]
osteopathic manipulative treatment [2973]
dietary [6]
pretest posttest design [108]

Abstract:

Background: Patients under antiestrogen hormonal treatment as adjuvant therapy after breast surgery may usually experience significant adverse events, which often negatively impact patient's Quality of Life. As a result of treatment‐related adverse events, failure to adhere to adjuvant therapies or discontinuation of treatment has been reported to be high in pre‐menopausal and post‐menopausal women. The Study hypothesis is that manual treatment with osteopathic techniques and dietary treatment focusing on patient‐centricity in a clinical trial, are able to improve physical performance, inflammatory state and quality of life of breast cancer patients undergoing antiestrogenic hormonal treatment maximizing patient’s compliance to adjuvant therapy after surgery. Materials and Methods: The Primary Objective of the study is the evaluation of the effects of dietary intervention and manual treatment with osteopathic techniques on improving the quality of life (QoL) of women diagnosed after breast surgery under antiestrogenic hormonal treatment. As the Primary outcome measure, QoL will be assessed using the FACT‐ES questionnaire, and the before‐and‐after treatment difference (at baseline, after 12 weeks, after 24 weeks and after 52 weeks) in the FACT‐ES scores questionnaire. As Secondary outcomes we will measure: symptoms related to antiestrogenic hormonal treatment using the scores of MRS‐Menopause Rating Scale and EORTC‐QLQ‐C30/BR23; body weight; body composition through anthropometric measures, dynamic tests and bioelectrical impedance vector analysis; food habits assessed through a food frequency questionnaire (FFQ); metabolic and inflammatory state through blood exams; physical performance through the International Physical Activity Questionnaires IPAQ. Patient’s satisfaction to multidisciplinary treatment will be assessed with questionnaire FACIT‐TS‐G. Results: We hypothesized a 5% reduction in FACT‐ES total score after 6 months in post‐menopausal patients without any dietetic and manual treatment with osteopathic techniques; 2.5% decrease for each of the two treatments singly administered; no variation with both dietary and manual treatment with osteopathic techniques. Conclusions: This study focuses on the side effects that long lasting antiestrogen hormonal therapies after surgery have on breast cancer survivors, ultimately increasing patient’s adherence to these therapies and having an impact on metabolic, inflammatory and immunologic status and, in perspective, on the general patient’s prognosis and survival.

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