A Randomised Effectiveness-implementation Trial for Evaluating Dietary and Manual Treatment With Osteopathic Techniques on Quality of Life and on Modulation of the Inflammatory State of Patients Diagnosed With Breast Cancer Undergoing Antiestrogenic Hormonal Treatment.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Contact Information
Primary
Cristina Ferraris, MD
cristina.ferraris@istitutotumori.mi.it
+39 02 2390 2659
Backup
Chiara Listorti, MD
chiara.listorti@istitutotumori.mi.it
+39 02 2390 2659
Time Frame
Start Date: 2023-12-19
Estimated Completion Date: 2025-12
Participants
Target number of participants: 600
Treatments
Experimental: A1: manual treatment with osteopathic techniques and nutritional treatment in premenopausal patients
Premenopausal breast cancer patients under tamoxifen and/or LHRH analogues are treated with manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques) and nutritional treatment (personalized Mediterranean Diet).
Experimental: A2: manual treatment with osteopathic techniques in premenopausal patients
Premenopausal breast cancer patients under tamoxifen and/or LHRH analogues are treated with manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques).
Experimental: A3: nutritional treatment in premenopausal patients
Premenopausal breast cancer patients under tamoxifen and/or LHRH analogues are treated with nutritional treatment (personalized Mediterranean Diet).
No_intervention: A4: control group in premenopausal patients
Premenopausal breast cancer patients under tamoxifen and/or LHRH analogues receive general counselling on healthy dietary habits and lifestyle in accordance to the World Cancer Research Fund (WCRF) guidelines.
Experimental: B1: osteopathic techniques and nutritional treatment in postmenopausal patients
Postmenopausal breast cancer patients under aromatase inhibitors are treated with manual treatment (8 once-a-week manual treatments with osteopathic techniques) and nutritional treatment (personalized Mediterranean Diet).
Experimental: B2: manual treatment with osteopathic techniques in postmenopausal patients
Postmenopausal breast cancer patients under aromatase inhibitors are treated with manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques).
Experimental: B3: nutritional treatment in postmenopausal patients
Postmenopausal breast cancer patients under aromatase inhibitors are treated with nutritional treatment (personalized Mediterranean Diet).
No_intervention: B4: control group in postmenopausal patients
Postmenopausal breast cancer patients under aromatase inhibitors receive general counselling on healthy dietary habits and lifestyle in accordance to the World Cancer Research Fund (WCRF) guidelines.
Related Therapeutic Areas
Sponsors
Leads: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

This content was sourced from clinicaltrials.gov