MedTrace Logo

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

NCT06164119 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

Interventions

OTHER

manual treatment with osteopathic techniques and nutritional treatment

manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques) and nutritional treatment (personalized Mediterranean Diet)

OTHER

manual treatment with osteopathic techniques

manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques)

OTHER

nutritional treatment

nutritional treatment (personalized Mediterranean Diet)

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Cristina Ferraris, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06164119 on ClinicalTrials.gov