Prehabilitation With Resistance-exercise Training for Breast Cancer Neoadjuvant Therapy

NCT06309290 | Recruiting DMC

• 1 other identifier: FAPESP-UFRO
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief Summary

Breast cancer stands as the foremost cause of cancer-related deaths among women worldwide, with the highest incidence of any cancer type. The choice of therapeutic interventions hinges upon factors like cancer stage, cell subtype, and tumor size. Consequently, individuals with more aggressive tumors, such as HER+2 and Triple Negative, or larger tumors often undergo neoadjuvant chemotherapy before breast surgery. However, these anticancer treatments come with side effects like cancer-related fatigue, reduced functional capacity, and changes in body composition, notably skeletal muscle atrophy. Skeletal muscle loss correlates with heightened mortality rates, cardiotoxicity, and diminished quality of life, underscoring the need for early therapeutic interventions. One such promising strategy is prehabilitation, which involves resistance-exercise training aimed at bolstering skeletal muscle mass from the outset of the disease, even preceding breast surgery. Resistance-exercise training has shown favorable effects on women undergoing adjuvant therapy or survivors of breast cancer, however, its molecular and clinical effects in women with breast cancer undergoing neoadjuvant therapy are unknown.

Conditions

Prehabilitation; Breast Cancer; Postmenopause; Resistance Training

Keywords

Prehabilitation; Breast neoplasm; Strength Training; Skeletal muscle; Muscle strength

Outcome Measures

Primary Outcomes (1)

• Change in skeletal muscle mass (measured via Computed tomography (CT) scan)

  Cross-sectional area of the quadriceps via single-slice CT scan

  Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery

Secondary Outcomes (8)

• Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing)

  Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery

• Change in hand grip strength (measured via JAMAR handheld dynamometer)

  Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery

• Change in physical performance measured via Short physical performance battery

  Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery

• Change in points quality of life measured via questionnaire European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)

  Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery

• Change in points Brief fatigue inventory (BFI)

  Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery

Study Arms (2)

Prehabilitation intervention program

EXPERIMENTAL

All volunteers be subjected to 16 - 20 weeks of full body resistance exercise training (2 times per week. However, usual care program.

Other: Prehabilitation with resistance-exercise training

Usual Care Program

ACTIVE COMPARATOR

All volunteers be subjected usual care (diagnosis confirmation, chemotherapy treatment planning and an initial education session).

Other: Usual care program

Interventions

Prehabilitation with resistance-exercise training OTHER

The volunteers in the intervention group will be subjected to 16 - 20 weeks of whole-body resistance-type exercise training (2x/wk).

Also known as: Prolonged resistance-type exercise training, Prehabilitation

Prehabilitation intervention program

Usual care program OTHER

The volunteers in the intervention group will be subjected to usual care (diagnosis confirmation, chemotherapy treatment planning and an initial education session).

Also known as: Standard therapy

Usual Care Program

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women with breast cancer in stages I, II and III with luminal breast tumor, HER2+ or TNBC
• Indication for neoadjuvant chemotherapy
• Candidates for curative breast surgery
• Body mass index: 18.5 \<BMI \<30 kg/m2
• Sedentary (does not perform scheduled or planned physical activity ≥ 2 times a week)
• Willingness to participate in the study and follow the proposed prehabilitation scheme.

You may not qualify if:

• Present comorbidities that interact with the metabolism and mobility of the muscles of the body and that do not allow the (safe) performance of strength exercises (e.g., debilitating arthritis, all neurological disorders, paralysis, among others).
• Severe or uncontrolled cardiovascular disease, cardiac ejection fraction less than 50%
• Previous antineoplastic treatment
• Use of nutritional supplements (leucine, glutamine, casein, whey protein, fatty acids and creatine).

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (2)

Fundación Arturo López Pérez

Santiago, Chile

RECRUITING

Department of Rehabilitation Sciences, Faculty of Medicine, Universidad de La Frontera. Temuco, Chile

Temuco, Chile

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Preoperative Exercise; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gabriel N Marzuca-Nassr, PT, MSc, PhD

  Universidad de La Frontera

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Macarena Artigas, PT, MSc

CONTACT

990420698; klga.macarena.artigas@gmail.com

Gabriel N Marzuca-Nassr, PT, MSc, PhD

CONTACT

+56 45 2596713; gabriel.marzuca@ufrontera.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 13, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)