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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano600 enrolled

Overview

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.

Breast cancer patients under hormonal therapy may experience significant adverse events related to this treatment. Premenopausal women may encounter the classic symptoms of menopausal syndrome: hair thinning or loss; hot flashes, sweating, fatigue, insomnia, joint pain, vaginal dryness, decreased libido, anxious-depressive disorders, cognitive dysfunction; dry eyes; weight gain. Postmenopausal women may instead experience joint stiffness and joint pain, depressive and anxious symptoms, fatigue and irritability. Since most of these adverse events do not resolve spontaneously a few weeks/months after starting treatment, they 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 and this may negatively impact patient's prognosis and survival. Patients with breast cancer frequently experience weight gain during and after adjuvant hormonal treatment. Indeed, menopause, musculoskeletal pain and the consequent physical activity reduction, work together to reduce the basal energy metabolism. On the other side, the psychological distress and the eventual use of food for emotional reward, do promote weight gain. Notably, breast cancer patients who are overweight or obese show an increased risk of overall mortality, cancer-specific mortality, breast cancer relapse or second primary contralateral breast cancer. The explanation lies in the fact that the increase in fat mass is directly correlated to an increased production of estrogens, insulin, leptin and proinflammatory cytokines which, all together, exhibit a mitogenic activity on mammary cells. Proinflammatory cytokines and insulin deregulation on their turn, favor with time the onset of other chronic diseases such as diabetes, dyslipidemia, metabolic syndrome in general, thus increasing the risk of overall mortality. Conversely, weight loss can improve hormonal status, quality of life and physical functioning and contribute to reduce cancer recurrence risk, cancer-related and chronic-condition-related mortality. Therefore, it is important to promote weight control and the adoption of healthy lifestyle habits in breast cancer survivors. Manipulation procedures, such as manual treatment with osteopathic techniques, involve the mechanical displacement of fluids and the removal of toxic substances with neurovascular and neuromuscular effects, thus producing positive alterations at the metabolic, biochemical and circulatory level. Several studies conducted on patients with breast cancer have supported the positive effect of manual therapy (acupuncture, shiatsu treatments, massages) on the control of various problems such as osteoarticular pain, peripheral neuropathies, anxious-depressive disorders, asthenia and sleep disorders, also improving immune and neuroendocrine responses. Nevertheless, there are no studies on the effect of manual treatment with osteopathic techniques on the control of symptoms related to the side effects induced by anti-tumor therapies. 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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Evaluation of the effect of dietary intervention and manual treatment with osteopathic techniques on quality of life (QoL) of women diagnosed with breast cancer under hormonal treatment

Quality of life will be assessed using the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire comparing the before-and-after treatment difference in FACT-ES QoL scale (range 0-200; the higher the FACT-ES score, the better the quality of life, QoL) evaluated at baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3). The difference between pre treatment (baseline, T0) score and 24-weeks (six months, T2) score of the FACT ES QoL scale will be analyzed by ANOVA, and the interaction between the dietetic treatment and manual treatment with osteopathic techniques will be tested at 5% significance level. In a secondary ANOVA analysis, the baseline-to-52-weeks (T3) follow-up difference of the FACT ES QoL scale scores will additionally be analyzed. These analyses will be conducted separately in Groups A and B.