Effect of Prehabilitation on Head and Neck Cancer Patients

Официальное название

Does Prehabilitation be Able to Favorably Impact on the Pathway of Head and Neck Cancer Patients, Candidate to Surgery or Chemoradiotherapy as Primary Treatment? A Prospective Clinical Trial

Обзор

The primary aim of the study is to investigate the feasibility of a prehabilitation program, which consists of a set of strategies including physical activity, nutritional support, and psychological counseling, carried out before and during cancer treatment for patients affected by head and neck tumors. About 4 weeks before surgery or the start of curative chemo-radiotherapy, the patient will begin the prehabilitation program, which will continue in parallel throughout the duration of the treatment and for up to 2 weeks after its completion. This prehabilitation program will include a combination of physical activity exercises, nutritional counseling, and psychological counseling sessions, all of which will be individualized for each patient. At the time of tumor diagnosis (T0), after 4 weeks of prehabilitation and before the start of the planned treatment (T1), 2 weeks after the end of treatment (T2), and after 6 months (T3), the patient will undergo a medical visit to collect anthropometric data, vital signs, a 6-minute walk test, and will complete a series of questionnaires aimed at assessing the risk of malnutrition, the development of anxiety and depression, and questionnaires to evaluate their quality of life. Throughout the duration of the study (i.e., up to T3, 6 months after the end of cancer treatment), the patient will wear an electronic watch, provided by the study, designed to measure vital signs, the number of daily steps, and the type and minutes of physical activity.

Подробное описание

Oncological prehabilitation is defined as the process within the care pathway that takes place between the moment of cancer diagnosis and the initiation of acute treatments. Prehabilitation aims to improve physical, emotional, and cognitive health before the start of cancer therapy, with the ultimate goal of preventing and reducing treatment-related comorbidities and mortality. It has also proven effective in reducing the adverse events of cancer therapies during the active phase of treatment, making it potentially useful at any stage of the care pathway for cancer patients. The role of exercise, nutrition, and stress reduction in improving outcomes for cancer patients has long been recognized in surgical prehabilitation, but the evidence for benefits in non-surgical cancer treatments is weaker due to fewer randomized clinical trials. Improvements in muscle strength, a reduction in cancer-related comorbidities (e.g., dyspnea, cardiotoxicity, urinary incontinence), and a positive impact on quality of life, including social well-being and a reduction in anxiety, depression, and stress, have been demonstrated. However, the literature regarding the role of multimodal prehabilitation in head and neck cancers is even weaker: there is limited data on feasibility and effectiveness, with most studies focusing on optimizing nutritional status in malnourished patients or improving dysphagia, but lacking data from prospective clinical trials. This study is designed as a prospective, multicenter, experimental, non-randomized, uncontrolled interventional trial. The objectives are: i) to evaluate the feasibility of prehabilitation before and during curative treatment for patients with head and neck cancer; ii) to investigate the efficacy outcomes of prehabilitation; iii) to conduct a cost-effectiveness analysis of prehabilitation.

Feasibility will be assessed by measuring patient acceptance, adherence, and satisfaction with the program. To evaluate adherence to the physical activity intervention, patients will be provided with wearable devices capable of measuring daily steps, type, and minutes of activity. To evaluate adherence to nutritional support, subjects will be asked to complete a food diary along with telephone interviews conducted by expert professionals. Adherence to psychological support requires a combination of self-reported measures, clinical evaluation, and behavioral observation. A patient will be considered adherent if they complete at least 80% of the assigned tasks. The investigators will consider prehabilitation feasible if more than 50% of patients in the treatment group adhere to the program for the entire scheduled period. To investigate the efficacy of the treatment, validated questionnaires on quality of life and the patient's health status will be administered. Secondary endpoints will include the difference between questionnaire scores at the end versus the beginning of the intervention in terms of variables quantifying the response to cancer treatments and the patient's physiological status. It will also be possible to calculate both the cost-effectiveness and cost-utility balance of the intervention, considering the difference between the intervention arm and the historical control arm in terms of quality-adjusted life years. The activities carried out to achieve this objective will allow us to characterize the changes between the start and end of the intervention. Any significant (positive or negative) variation between the start and end of the intervention will be considered a result.

Вмешательства

• Другое Prehabilitation before surgery
  Prehabilitation multimodal program will start about 4 weeks before the surgery and will be continued until 2 weeks after the surgical intervention. Multimodal program comprises physical exercise, nutritional intervention, and psychological support provided before and during curative treatment for HNC patients.
• Другое Prehabilitation before and during CRT
  Prehabilitation multimodal program will start about 4 weeks CRT and will be continued in parallel until 2 weeks after the end. Multimodal program comprises physical exercise, nutritional intervention, and psychological support provided before and during curative treatment for HNC patients.

Первичные конечные точки

• Feasibility of multimodal prehabilitation [Срок оценки: From enrollment to the end of prehabilitation program, 2 weeks after the end of curative treatment]
• Efficacy of multimodal prehabilitation [Срок оценки: From enrollment to 2 weeks after the end of oncological treatment]
• Cost-effectiveness of multimodal prehabilitation [Срок оценки: From the enrollment to 6 months after the end of the oncological treatment]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Candidate to curative treatment (platinum-based chemoradiotherapy or surgery + RT +/- CT)
• ECOG PS 0-1
• Fit for prehabilitation program (medical, physical, and mental conditions that don't contraindicate physical exercise and oral nutrition)
• Ability to understand and adhere to exercise or lifestyle modifications
• Date of treatment beginning no later than 60 days from baseline assessment
• Provide valid informed consent prior to any study procedure

Критерии исключения

• Unstable medical condition requiring immediate attention (e.g uncontrolled heart failure; unstable angina; severe respiratory distress) must prioritize
• Patients with very advanced stage of disease, candidate to palliative treatment
• Uncontrolled cancer symptoms or pain
• Need for early treatment initiation
• Frailty subjects: patients with severe functional impairment
• Significant muscle wasting, limiting the participation in prehabilitation exercise
• Severe cognitive or mental health issues, precluding prehabilitation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 5 центров

• Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale — Naples
• Fondazione IRCCS Policlinico San Matteo — Pavia
• Istituti Clinici Scientifici Maugeri — Pavia
• National Center of Adrotherapy Oncology — Pavia
• Azienda Ospedaliero Universitaria di Sassari — Sassari

Публикации

• Cantwell LA, Fahy E, Walters ER, Patterson JM. Nutritional prehabilitation in head and neck cancer: a systematic review. Support Care Cancer. 2022 Nov;30(11):8831-8843. doi: 10.1007/s00520-022-07239-4. Epub 2022 Aug 1. PMID 35913625
• Loughney L, West MA, Moyses H, Bates A, Kemp GJ, Hawkins L, Varkonyi-Sepp J, Burke S, Barben CP, Calverley PM, Cox T, Palmer DH, Mythen MG, Grocott MPW, Jack S; Fit4Surgery group. The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients: a randomised controlled trial (The EMPOWER T PMID 34154675
• Urvaylioglu AE, Kutluturkan S, Kilic D. Effect of Kegel exercises on the prevention of urinary and fecal incontinence in patients with prostate cancer undergoing radiotherapy. Eur J Oncol Nurs. 2021 Apr;51:101913. doi: 10.1016/j.ejon.2021.101913. Epub 2021 Feb 15. PMID 33639454
• Halkett G, O'Connor M, Jefford M, Aranda S, Merchant S, Spry N, Kane R, Shaw T, Youens D, Moorin R, Schofield P; RT Prepare project team. RT Prepare: a radiation therapist-delivered intervention reduces psychological distress in women with breast cancer referred for radiotherapy. Br J Cancer. 2018 Jun;118(12):1549-1558. doi: 10.1038/s41416-018-0112-z. Epub 2018 Jun 1. PMID 29855611
• Goldsmith I, Chesterfield-Thomas G, Toghill H. Pre-treatment optimization with pulmonary rehabilitation in lung cancer: Making the inoperable patients operable. EClinicalMedicine. 2020 Nov 30;31:100663. doi: 10.1016/j.eclinm.2020.100663. eCollection 2021 Jan. PMID 33554075
• Quist M, Langer SW, Lillelund C, Winther L, Laursen JH, Christensen KB, Rorth M, Adamsen L. Effects of an exercise intervention for patients with advanced inoperable lung cancer undergoing chemotherapy: A randomized clinical trial. Lung Cancer. 2020 Jul;145:76-82. doi: 10.1016/j.lungcan.2020.05.003. Epub 2020 May 8. PMID 32416432
• Lippi L, Turco A, Moalli S, Gallo M, Curci C, Maconi A, de Sire A, Invernizzi M. Role of Prehabilitation and Rehabilitation on Functional Recovery and Quality of Life in Thyroid Cancer Patients: A Comprehensive Review. Cancers (Basel). 2023 Sep 10;15(18):4502. doi: 10.3390/cancers15184502. PMID 37760472
• Howe L, Husband A, Robinson-Barella A. Prescribing pre- and post-operative physical activity interventions for people undergoing breast cancer surgery: A qualitative systematic review. Cancer Med. 2024 Feb;13(4):e7063. doi: 10.1002/cam4.7063. PMID 38457236

Идентификаторы

NCT: NCT06593639 · PNRR-TR1-2023-12377022 · PNRR-TR1-2023-12377022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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