Diet and osteopathy effects on quality of life in breast cancer patients on hormonal therapy
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.
This study is testing whether changes in diet and hands-on treatments can help improve the quality of life for women with breast cancer who are on hormonal therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan) |
| Trial ID | NCT06164119 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of dietary interventions and osteopathic manual treatments on the quality of life and inflammation in women diagnosed with breast cancer who are undergoing hormonal therapy. It aims to address the significant adverse events associated with hormonal treatments, such as menopausal symptoms and weight gain, which can lead to decreased adherence to therapy. By promoting healthy lifestyle habits and utilizing osteopathic techniques, the study seeks to improve patients' physical functioning and overall well-being. Participants will be assessed for changes in their quality of life and treatment-related symptoms throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates include women over 18 years old with estrogen receptor-positive breast cancer currently on hormonal therapy.
Not a fit: Patients with a BMI under 18.5 kg/m² or those with psychiatric disorders or previous malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for breast cancer patients undergoing hormonal therapy and reduce treatment-related adverse effects.
How similar studies have performed: Other studies have shown promising results with dietary and osteopathic interventions in improving quality of life for cancer patients, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Cristina Ferraris, MD — Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
- Study coordinator: Cristina Ferraris, MD
- Email: cristina.ferraris@istitutotumori.mi.it
- Phone: +39 02 2390 2659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.