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

Официальное название

Impact of Prehabilitation With Exercise and Nutrition, and Comprehensive Follow-up in Women With Breast Cancer: The PREACT Trial

Обзор

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.

Подробное описание

The administration of breast cancer (BC) treatments is associated with various adverse events and acute toxicities that negatively affect molecular, functional, and clinical outcomes in patients with BC. Additionally, these adverse events may reduce treatment tolerance \[e.g., relative dose intensity (RDI)\], which has been shown to be associated with a worse prognosis in this population. Implementing a high-intensity concurrent training program and specific nutritional guidelines during this phase could reduce adverse treatment events and improve recovery. Likewise, including an unsupervised exercise program and nutritional guidelines during the rest of the cancer treatment may enhance the benefits obtained and improve different outcomes related to the patients' functionality, clinical status, quality of life, and treatment tolerance. Therefore, the aim of this study is to determine the effects of a prehabilitation program (combining high-intensity concurrent training and personalized nutritional guidelines) and a supportive care intervention (home-based exercise and personalized nutritional guidelines) on different outcomes in newly diagnosed women with BC.

This prospective, two-arm parallel randomized controlled trial will be conducted in Valladolid (Castilla y León, Spain). A total of 66 newly diagnosed women with BC will be recruited through medical and diagnostic appointments. Women will be recruited immediately after diagnosis and must be scheduled to receive neoadjuvant chemotherapy or hormone therapy, surgery, or radiation therapy. After completion of baseline study assessments, participants will be randomized to an experimental group or a control group. 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 during the medical treatment period. Participants in the control group will be asked to continue their usual care and will receive general recommendations for physical exercise and nutrition. Molecular (inflammation-related proteins, epinephrine and norepinephrine), functional (cardiorespiratory fitness, 30-Second Sit-to-Stand Test, Six-Minute Walk Test, handgrip strength and maximal voluntary isometric contraction), clinical (body composition, muscle thickness, and arm volume), and patient-reported (quality of life, upper-limb disability, fatigue, 24-hour nutritional record and food frequency questionnaire) outcomes will be assessed at baseline (week 0) and at various points during the scheduled cancer-associated treatments. Treatment tolerance (relative dose intensity, dose reduction, dose delay, early discontinuation of treatment, and number of patients completing the planned total dose) and treatment-related complications (seroma, infection; hematoma, wound dehiscence, persistent post-surgical pain, lymphedema, neuropathy, and thromboembolism) will be recorded throughout the continuum of treatments.

Вмешательства

• Другое Prehabilitation: Exercise and nutrition
  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 a

Первичные конечные точки

• Cardiorespiratory fitness (peak oxygen consumption): Direct method [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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).]

Вторичные конечные точки (12)

• Handgrip strength [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline; up to 1 week after prehabilitation; 1 week after surgery or immediately after completion of the first treatment.]
• Epinephrine and norepinephrine [Срок оценки: Baseline; 1 week before initiation of the first treatment (radiotherapy, chemotherapy or hormone therapy).]
• Weight [Срок оценки: 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).]
• Height [Срок оценки: 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).]
• Body composition (Bioimpedance) [Срок оценки: Baseline; 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).]
• Muscle thickness: vastus lateralis [Срок оценки: Baseline; 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).]
• Muscle thickness: rectus femoris [Срок оценки: Baseline; 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).]
• Arm volume [Срок оценки: Baseline; 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).]
• Health-related quality of life [Срок оценки: Baseline; 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).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 2 центра

• Hospital Recoletas Campo Grande — Valladolid
• Miguel de Cervantes European University — Valladolid

Публикации

• Foulkes SJ, Howden EJ, Haykowsky MJ, Antill Y, Salim A, Nightingale SS, Loi S, Claus P, Janssens K, Mitchell AM, Wright L, Costello BT, Lindqvist A, Burnham L, Wallace I, Daly RM, Fraser SF, La Gerche A. Exercise for the Prevention of Anthracycline-Induced Functional Disability and Cardiac Dysfunction: The BREXIT Study. Circulation. 2023 Feb 14;147(7):532-545. doi: 10.1161/CIRCULATIONAHA.122.06281 PMID 36342348
• Forsythe LP, Alfano CM, George SM, McTiernan A, Baumgartner KB, Bernstein L, Ballard-Barbash R. Pain in long-term breast cancer survivors: the role of body mass index, physical activity, and sedentary behavior. Breast Cancer Res Treat. 2013 Jan;137(2):617-30. doi: 10.1007/s10549-012-2335-7. Epub 2012 Dec 15. PMID 23242613
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• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07467824 · PI-DOC011-PREACT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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