RecruitingNot ApplicableNCT07107594

Multimodal Prehabilitation Program That Combines Physical Exercise, Psychological Intervention and Nutritional Support to Improve the Response to Neoadjuvant Chemoterhapy in Early Breast Cancer Patients

Multimodal Intervention During Neoadjuvant Chemotherapy in Patients With Early-breast Cancer as a Strategy to Improve Treatment Response: DIANA Trial (Multimodal Prehabilitation: DIet, ANxiety Control Psychotherapy, Physical Activity)

Sponsor

Hospital Clinic of Barcelona

Enrollment

214 participants

Start Date

Jan 14, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)Prehabilitation

Summary

The aim of this clinical trial is to evaluate whether following a multimodal prehabilitation program including physical exercise, nutritional support and psychological intervention during neoadjuvant chemotherapy in breast cancer patients could improve the pathological response to chemotherapy. 214 women with non-metastatic breast cancer with indication of chemotherapy before surgery will be eligible to participate. Patients will be randomly assigned to either the intervention group or the control group. * Patients assigned to the intervention group (107 women) will undergo a directed multimodal prehabilitation program during the chemotherapy (4-6 months), including structured physical exercise, psychological intervention and nutritional guidance. * Patients assigned to the control group (107 women) will undergo standard clinical management for their disease without multimodal prehabilitation. The response to chemotherapy between the two groups will be evaluated and compared. It is expected that multimodal prehabilitation will increase the response to chemotherapy and will improve the postoperative recovery of patients and their quality of life, as well as reducing the number of complications from surgery and chemotherapy treatment. Changes in the tumor microenvironment are also expected after prehabilitation.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

Histologically confirmed diagnosis of non-metastatic breast cancer: stages cT1-T4, cN0-N3, M0, and candidates for neoadjuvant chemotherapy (NAC).
Age ≥ 18 years.
Signed informed consent.

Exclusion Criteria8

Contraindication or physical inability to perform moderate-to-high intensity physical exercise.
Pregnant or breastfeeding patients.
Presence of other active synchronous neoplasms.
Metastatic breast cancer (stage IV).
Patients already engaging in regular physical exercise: more than 150 minutes of moderate or intense aerobic exercise per week.
Male breast cancer patients.
Personal history of a previous malignancy treated with chemotherapy.
Severe or poorly controlled psychiatric illness (including uncontrolled active substance abuse).

Interventions

BEHAVIORALMultimodal prehabilitation

Multimodal prehabilitation program during NACT (4-6 months) that will combine: 1) Physical exercise: cardiovascular and strength exercises designed by specialized physiotherapists, structured in 1-hour sessions twice a week. The characteristics of the activity will be adapted to the treatment phase and the physical condition of each woman. 2) Psychological therapies: standardized mindfullness practice by a specialized psychologist. As an alternative, patients who refuse mindfullness could receive psychological sessions on stress and anxiety management. 3) Nutritional counseling: periodic sessions with a specialized nutritionist providing dietary recommendations and nutritional advice adapted to the disease and condition of the patients.