Effects of Diet and Osteopathy on Quality of Life and Inflammation in Breast Cancer Patients Under Hormonal Therapy

Breast cancer patients under hormonal therapy may experience significant adverse events related to this treatment and as a result, failure to adhere to adjuvant therapies or discontinuation of treatment has been reported to be high. Promoting weight control and the adoption of healthy lifestyle habits in breast cancer survivors has an impact on hormonal status, quality of life and physical functioning, contributing to reduce cancer recurrence risk, cancer-related and chronic-condition-related mortality. Manipulation procedures, such as manual treatment with osteopathic techniques, have positive effects on osteoarticular pain, peripheral neuropathies, anxious-depressive disorders, asthenia and sleep disorders, also improving immune and neuroendocrine responses. The aim of this study is to evaluate the effects of dietary intervention and manual treatment with osteopathic techniques in women diagnosed with breast cancer under antiestrogenic hormonal treatment through the assessment of: * modifications of quality of life (QoL) * frequency and severity of symptoms related to antiestrogenic hormonal treatment * body weight * body composition * food habits * metabolic and inflammatory state * physical performance * patient's satisfaction to multidisciplinary treatment. This study focuses on patient's centricity evaluating the effects that long lasting adjuvant therapies have on breast cancer survivors. Improving personalized patient's treatment through collaborative interactions between clinicians, osteopaths and nutrition specialists might result in implementation strategies to determine novel evidence-based treatments for ameliorating patient's adherence to oncological therapies, impacting prognosis and survival.

Sex

Female

Minimum age

18 Years

Maximum age

85 Years

Inclusion Criteria:

* Age \>18 years
* Voluntary written informed consent
* Histologically confirmed estrogen receptor-positive invasive breast cancer or in situ breast cancer after breast surgery
* Absence of locoregional relapse or distant metastasis
* Premenopausal or postmenopausal status
* Hormonal therapy with tamoxifen and/or LHRH analogues or aromatase inhibitors
* Patients with or without neoadjuvant or adjuvant chemotherapy
* Patients with a BMI \> 18.5 kg/m\^2
* Absence of language barrier

Exclusion Criteria:

* Previous hormonal therapy
* Use of medical treatments that contrast adjuvant hormonal therapy adverse effects (e.g. menopausal symptoms and arthralgia).
* Underweight patients (BMI \<18.5 kg/m\^2)
* Patients diagnosed with eating disorders (e.g. anorexia nervosa, bulimia, binge eating, orthorexia)
* Psychiatric disorders or cognitive impairments
* Previous malignancies other than in situ cervical carcinoma or non-melanoma skin cancer
* Non-epithelial breast cancer at histological examination
* In situ lobular breast cancer
* Participation in other randomized clinical trials that could interfere with current study
* Patients living distant from trial center and unable to attend for check-ups and meetings.

• BACKGROUNDSauter ER. Breast Cancer Prevention: Current Approaches and Future Directions. Eur J Breast Health. 2018 Apr 1;14(2):64-71. doi: 10.5152/ejbh.2018.3978. eCollection 2018 Apr. PMID 29774312
• BACKGROUNDSharma R, Hamilton A, Beith J. LHRH agonists for adjuvant therapy of early breast cancer in premenopausal women. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004562. doi: 10.1002/14651858.CD004562.pub3. PMID 18843661
• BACKGROUNDMartino G, Catalano A, Agostino RM, Bellone F, Morabito N, Lasco CG, Vicario CM, Schwarz P, Feldt-Rasmussen U. Quality of life and psychological functioning in postmenopausal women undergoing aromatase inhibitor treatment for early breast cancer. PLoS One. 2020 Mar 26;15(3):e0230681. doi: 10.1371/journal.pone.0230681. eCollection 2020. PMID 32214378
• BACKGROUNDGlaus A, Boehme Ch, Thurlimann B, Ruhstaller T, Hsu Schmitz SF, Morant R, Senn HJ, von Moos R. Fatigue and menopausal symptoms in women with breast cancer undergoing hormonal cancer treatment. Ann Oncol. 2006 May;17(5):801-6. doi: 10.1093/annonc/mdl030. Epub 2006 Feb 28. PMID 16507565
• BACKGROUNDMantas, D., Kostakis, J.D. & Markopoulos, C. Aromatase inhibitors: A comprehensive review in mechanisms of action, side effects and treatment in postmenopausal early breast cancer patients. Hellenic J Surg 88, 245-251 (2016). https://doi.org/10.1007/s13126-016-0326-6
• BACKGROUNDHenry NL, Azzouz F, Desta Z, Li L, Nguyen AT, Lemler S, Hayden J, Tarpinian K, Yakim E, Flockhart DA, Stearns V, Hayes DF, Storniolo AM. Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early-stage breast cancer. J Clin Oncol. 2012 Mar 20;30(9):936-42. doi: 10.1200/JCO.2011.38.0261. Epub 2012 Feb 13. PMID 22331951
• BACKGROUNDSestak I, Cuzick J, Sapunar F, Eastell R, Forbes JF, Bianco AR, Buzdar AU; ATAC Trialists' Group. Risk factors for joint symptoms in patients enrolled in the ATAC trial: a retrospective, exploratory analysis. Lancet Oncol. 2008 Sep;9(9):866-72. doi: 10.1016/S1470-2045(08)70182-7. Epub 2008 Aug 12.