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

NCT07107594 | Recruiting

• 1 other identifier: HCB/2023/1036
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Breast cancer; Early breast cancer; Prehabilitation; Multimodal prehabilitation; Neoadjuvant chemotherapy; Lifestyle; Quality of life

Outcome Measures

Primary Outcomes (1)

• Residual Cancer Burden Index (RCB)

  The main variable of the trial is the RCB index score, obtained from the histological specimen of the oncological surgery performed after NAC. The four levels of response of the RCB index (RCB 0, I, II and III) will be divided into a favorable profile of response (fRCB), that will include cathegories RCB 0 and I, and an unfavorable response profile (uRCB), including RCB II and III. It is estimated that the average rate of a favorable RCB (fRCB) score, including RCB 0 and RCB I, will be approximately 40% in the control arm. Parallelly, the expected rates of unfavorable RCB (uRCB) scores, including RCB II and RCB III, are 60%. The objective is to improve the response rates by 20% in the intervention group, with 60% of fRCB scores and 40% of uRCB scores in this group.

  From enrollment (baseline, day 1) until the end of treatment at 4-6 months (preoperative).

Secondary Outcomes (23)

• Tumor microenvironment (Gene expression analyses)

  From enrollment (baseline, day 1) until the end of treatment at 4-6 months (postoperative).

• Tumor staging

  At diagnosis or day 1 (clinical TNM or cTNM) and after surgery (pathological TNM or pTNM)

• Tumor cellularity after NACT

  After the surgery (after NACT, 4-6 months from day 1)

• Assessment of vascular density in peritumoral areas

  At enrollment (baseline, day 1) and at the end of treatment at 4-6 months (postoperative).

• Adverse effects of neoadjuvant chemotherapy

  After the treatment (4-6 months later, presurgical).

Study Arms (2)

Control

NO INTERVENTION

107 women that will follow the standard of care. Patients in the control group will receive proper information and recommendations about lifestyle modifications according to the most recent oncological guidelines. The benefits of physical exercise, a healthy diet and psychological support will be exposed, but such interventions will not be provided in our centre.

Prehabilitation

EXPERIMENTAL

107 women that will follow the multimodal prehabilitation program during NACT (physical exercise, psychological intervention, nutritional support).

Behavioral: Multimodal prehabilitation

Interventions

Multimodal prehabilitation BEHAVIORAL

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.

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Fundació La Marató de TV3: collaborator

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Spain

RECRUITING

Related Publications (17)

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Related Links

• Breast cancer statistics

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Berta Díaz-Feijoo, MD, PhD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

• Eduard Mension Coll, MD, PhD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

Central Study Contacts

Helena Castillo Espín, MD

CONTACT

+34 651024667; hcastillo@clinic.cat

Eduard Mension Coll, MD, PhD

CONTACT

+34 626 20 71 71; mension@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The pathologist responsible for analyzing the pathological response to the treatment will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (MD), Specialized in Gynecology and Obstetrics

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: August 6, 2025
• Study Start: January 14, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)