Status:
UNKNOWN
Effects of Diet and Osteopathy on Quality of Life and Inflammation in Breast Cancer Patients Under Hormonal Therapy
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-85 years
Phase:
NA
Brief 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 treatme...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06164119
Start Date
December 19 2023
End Date
December 1 2025
Last Update
March 8 2024
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133