Impact of Prehabilitation and Comprehensive Follow-up in Women With Breast Cancer

NCT07467824 | Recruiting

• 1 other identifier: PI-DOC011-PREACT
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

Breast cancer (BC) is the most common cancer among women worldwide. Cancer treatments are associated with numerous adverse events that reduce patients' functionality and alter their clinical and molecular profiles. Physical exercise and adherence to nutritional guidelines during treatment and survivorship have been shown to improve recovery prognosis and reduce treatment-related complications. However, the specific effects of prehabilitation, defined as "the process in the cancer continuum that occurs between diagnosis and the start of treatment," remain unknown in BC. A concurrent training program and specific nutritional guidelines during this phase could reduce treatment-related adverse events and improve recovery. Similarly, including a home-based exercise program and nutritional guidelines throughout the cancer treatment continuum could enhance the benefits achieved and improve various aspects of functionality, clinical status, and quality of life. Therefore, the main aim of this randomized controlled trial is to evaluate the impact and effects of a supervised prehabilitation program (combining high-intensity concurrent training and personalized nutritional guidelines) and a supportive care intervention (home-based exercise and personalized nutritional guidelines) on functional, neuromuscular, and cardiorespiratory capacity, quality of life, body composition, and clinical and molecular outcomes in women with BC. In addition, the sustainability of the benefits achieved in the long-term care and the evolution of the outcomes assessed throughout the continuum of cancer treatments will be analyzed.

Conditions

Breast Cancer; Breast Neoplasms

Keywords

prehabilitation; exercise; nutrition; training

Outcome Measures

Primary Outcomes (3)

• Cardiorespiratory fitness (peak oxygen consumption): Direct method

  The change in peak oxygen consumption (ml·kg-¹·min-¹) will be assessed. A Wattbike AtomX cycle ergometer (Wattbike, Nottingham, England) and a stationary gas analyzer (Cortex Metalyzer 3B, Leipzig, Germany) will be used in the study. A gradual incremental exercise protocol will be applied, starting at 50 watts with increments of 25 watts every two minutes, until voluntary exhaustion is reached or medical reasons are presented to end exercise.

  Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.

• Cardiorespiratory fitness: Indirect method (30-Second Sit-to-Stand Test)

  The change in the estimated peak of oxygen consumption (ml·kg-¹·min-¹) will be assessed.

  Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).

• Cardiorespiratory fitness: Indirect method (Six-Minute Walk Test)

  The change in the estimated peak of oxygen consumption (ml·kg-¹·min-¹) will be assessed.

  Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).

Secondary Outcomes (30)

• Handgrip strength

  Baseline; up to 1 week after prehabilitation; 1 week post-surgery, up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks)

• Upper-body maximal voluntary isometric contraction: Chest press

  Baseline; up to 1 week after prehabilitation; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks)

• Lower-body maximal voluntary isometric contraction: Squat

  Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).

• Inflammation-related proteins

  Baseline; up to 1 week after prehabilitation; 1 week after surgery or immediately after completion of the first treatment.

• Epinephrine and norepinephrine

  Baseline; 1 week before initiation of the first treatment (radiotherapy, chemotherapy or hormone therapy).

Study Arms (2)

Exercise and nutrition group

EXPERIMENTAL

Participants assigned to the experimental group will undergo a supervised prehabilitation program consisting of structured exercise training and personalized nutritional guidelines, followed by a home-based program (exercise and nutrition) during the treatment period.

Other: Prehabilitation: Exercise and nutrition

Control group

NO INTERVENTION

Participants assigned to this group will be asked to continue their usual care and will receive general recommendations for physical activity and nutrition.

Interventions

Prehabilitation: Exercise and nutrition OTHER

Prehabilitation phase: * Exercise training: During a 2-4-week prehabilitation phase, participants will perform supervised concurrent training sessions, including a high-intensity circuit of multi-joint resistance exercises and a high-intensity interval training. * Nutrition: A dietitian will implement a 2-4-week structured plan providing 25-30 kcal/kg/day, 1.2-1.5 g protein/kg/day, at least 150 g carbohydrates/day, and ≥5 meals/day. The plan will also ensure adequate vitamins and antioxidants and include guidance on portion distribution to meet recommended intake of all food groups. Neoadjuvant or adjuvant treatment phase: * Exercise training: After treatment begins, participants will follow a home-based training plan during treatment: 3 weekly elastic-band resistance sessions + ≥150 min/week aerobic exercise. First week supervised; then remote follow-up. * Nutrition: The participants will continue the guidelines provided during the prehabilitation phase.

Exercise and nutrition group

Eligibility Criteria

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

You may qualify if:

• Women who have a newly confirmed diagnosis of stage 0-III breast cancer.
• Age 18 to 65 years old with a body mass index between 18.5 and 35 kg·m-².
• Have a medical indication for surgery or neoadjuvant systemic treatment (chemotherapy or hormone therapy) or radiotherapy.
• Be able to perform supervised physical exercise, as determined by prior medical assessment.
• Understand and voluntarily sign the written informed consent before the start of the study.

You may not qualify if:

• Women with a diagnosis of metastatic breast cancer.
• Women with any medical condition that contraindicates physical exercise, such as severe cardiovascular disease, significant respiratory or kidney failure.
• Women with presence of serious uncontrolled comorbidities, such as decompensated diabetes, severe hypertension or acute psychiatric disorders, among others.
• Women with severe functional limitations that prevent planned interventions from being performed (e.g., physical disabilities that compromise exercise).
• Women who are pregnant, breastfeeding, or likely to become pregnant during the trial or who have inability to communicate.

Sponsors & Collaborators

• European University Miguel de Cervantes: lead

Study Sites (2)

Hospital Recoletas Campo Grande

Valladolid, Valladolid, 47007, Spain

RECRUITING

Miguel de Cervantes European University

Valladolid, Valladolid, 47012, Spain

RECRUITING

Related Publications (12)

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  PMID: 36342348 BACKGROUND

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  PMID: 23242613 BACKGROUND

• Jiang M, Ma Y, Yun B, Wang Q, Huang C, Han L. Exercise for fatigue in breast cancer patients: An umbrella review of systematic reviews. Int J Nurs Sci. 2020 Mar 10;7(2):248-254. doi: 10.1016/j.ijnss.2020.03.001. eCollection 2020 Apr 10.

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• Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.

  PMID: 33239350 BACKGROUND

• Torcasio R, Gallo Cantafio ME, Ikeda RK, Ganino L, Viglietto G, Amodio N. Lipid metabolic vulnerabilities of multiple myeloma. Clin Exp Med. 2023 Nov;23(7):3373-3390. doi: 10.1007/s10238-023-01174-2. Epub 2023 Aug 28.

  PMID: 37639069 BACKGROUND

• Demark-Wahnefried W, Campbell KL, Hayes SC. Weight management and its role in breast cancer rehabilitation. Cancer. 2012 Apr 15;118(8 Suppl):2277-87. doi: 10.1002/cncr.27466.

  PMID: 22488702 BACKGROUND

• Schmid D, Leitzmann MF. Cardiorespiratory fitness as predictor of cancer mortality: a systematic review and meta-analysis. Ann Oncol. 2015 Feb;26(2):272-8. doi: 10.1093/annonc/mdu250. Epub 2014 Jul 9.

  PMID: 25009011 BACKGROUND

• Chen X, Shi X, Yu Z, Ma X. High-intensity interval training in breast cancer patients: A systematic review and meta-analysis. Cancer Med. 2023 Sep;12(17):17692-17705. doi: 10.1002/cam4.6387. Epub 2023 Aug 17.

  PMID: 37587859 BACKGROUND

• Castro-Espin C, Cairat M, Navionis AS, Dahm CC, Antoniussen CS, Tjonneland A, Mellemkjaer L, Mancini FR, Hajji-Louati M, Severi G, Le Cornet C, Kaaks R, Schulze MB, Masala G, Agnoli C, Sacerdote C, Crous-Bou M, Sanchez MJ, Amiano P, Chirlaque MD, Guevara M, Smith-Byrne K, Heath AK, Christakoudi S, Gunter MJ, Rinaldi S, Agudo A, Dossus L. Prognostic role of pre-diagnostic circulating inflammatory biomarkers in breast cancer survival: evidence from the EPIC cohort study. Br J Cancer. 2024 Nov;131(9):1496-1505. doi: 10.1038/s41416-024-02858-6. Epub 2024 Sep 28.

  PMID: 39342063 BACKGROUND

• Ligibel JA, Dillon D, Giobbie-Hurder A, McTiernan A, Frank E, Cornwell M, Pun M, Campbell N, Dowling RJO, Chang MC, Tolaney S, Chagpar AB, Yung RL, Freedman RA, Dominici LS, Golshan M, Rhei E, Taneja K, Huang Y, Brown M, Winer EP, Jeselsohn R, Irwin ML. Impact of a Pre-Operative Exercise Intervention on Breast Cancer Proliferation and Gene Expression: Results from the Pre-Operative Health and Body (PreHAB) Study. Clin Cancer Res. 2019 Sep 1;25(17):5398-5406. doi: 10.1158/1078-0432.CCR-18-3143. Epub 2019 Apr 24.

  PMID: 31018921 BACKGROUND

• Brahmbhatt P, Sabiston CM, Lopez C, Chang E, Goodman J, Jones J, McCready D, Randall I, Rotstein S, Santa Mina D. Feasibility of Prehabilitation Prior to Breast Cancer Surgery: A Mixed-Methods Study. Front Oncol. 2020 Sep 25;10:571091. doi: 10.3389/fonc.2020.571091. eCollection 2020.

  PMID: 33072603 BACKGROUND

• Del Bianco N, Borsati A, Toniolo L, Ciurnielli C, Belluomini L, Insolda J, Sposito M, Milella M, Schena F, Pilotto S, Avancini A. What is the role of physical exercise in the era of cancer prehabilitation? A systematic review. Crit Rev Oncol Hematol. 2024 Jun;198:104350. doi: 10.1016/j.critrevonc.2024.104350. Epub 2024 Apr 18.

  PMID: 38642726 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Alejandro Santos Lozano, PhD

  Miguel de Cervantes European University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Santos Lozano, PhD

CONTACT

+34 983001000; asantos@uemc.es

Celia García Chico, PhD

CONTACT

+34 983001000; cgarciac@uemc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The person analyzing the data collected (investigators, statisticians) will not know to which group each person belongs.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single-center randomized controlled trial.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)