Effect of Prehabilitation on Head and Neck Cancer Patients

NCT06593639 | Recruiting

• 1 other identifier: PNRR-TR1-2023-12377022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; prehabilitation; physical exercise; malnutrition; nutritional intervention; psychological support; cisplatin; hadrontherapy; ENT surgery

Outcome Measures

Primary Outcomes (3)

• Feasibility of multimodal prehabilitation

  The feasibility will be measured by the rate of adherence to prehabilitation interventions. To assess the adherence to the physical activity intervention, the investigators will equip patients with commercially available activity trackers. Patients will wear the activity tracker until 6 months after the end of treatment. To assess the adherence to the nutritional intervention a telephone 24-hour dietary recall (24HR) interview will be employed. 24HR is a retrospective method that monitors and assesses the food and drinks consumption of the subjects during the previous day. Adherence to psycho-oncological support requires a combination of self-report measure, clinical assessment and behavioral observation. The three reports will be aggregated to a one reported value: a patient will be considered adherent to prehabilitation program if they will be adherent to each intervention.

  From enrollment to the end of prehabilitation program, 2 weeks after the end of curative treatment

• Efficacy of multimodal prehabilitation

  A comparison between T0 (cancer diagnosis) and the other time points (T1: after 4 weeks of prehabilitation, T2: 2 weeks after the end of oncological treatments, T3: at 6 months of follow-up) will be made to exploit any differences. To test the efficacy of physical activity, the functional capacity over time will be monitored, measuring as the difference in absolute change in 6-minute walk distance (6MWD) between T0 and T1 and between T0 and T2. In addition, the Handgrip strength (HGS) will be employed as a biomarker of overall health status. Two questionaries (i.e. NRS-2002 and MUST) will be used as screening tools to exploit the risk of malnourishment. ASonA, Distress Thermometer, and FACT- HN will be used to test the psycho-oncological intervention efficacy. The three reports will be aggregated to a one reported value: the program will be considered effective if each intervention will be effective.

  From enrollment to 2 weeks after the end of oncological treatment

• Cost-effectiveness of multimodal prehabilitation

  To evaluate the sustainability, the cost-utility analysis of the prehabilitation intervention will be evaluated. Cost Utility Analysis is an economic analysis comparing the incremental cost of a program to the incremental health improvement in terms of quality adjusted life years (QALYs). The EORTC QLQ-C30 questionnaire will be used to predict EQ-5D-5L through a mapping algorithm, which is one of the most used instrument for measuring QALYs.

  From the enrollment to 6 months after the end of the oncological treatment

Study Arms (2)

Surgery plus (chemo)radiotherapy

EXPERIMENTAL

Head and neck cancer patients undergoing surgery before (chemo)radiotherapy according to stage and risk factors.

Other: Prehabilitation before surgery

Chemo-radiotherapy

EXPERIMENTAL

Head and neck cancer patients undergoing definitive concomitant chemo-radiotherapy (CRT) according to stage and risk factors.

Other: Prehabilitation before and during CRT

Interventions

Prehabilitation before and during CRT OTHER

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.

Chemo-radiotherapy

Prehabilitation before surgery OTHER

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.

Also known as: physical exercise, nutritional intervention, psychological support

Surgery plus (chemo)radiotherapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale: collaborator
• CNAO National Center of Oncological Hadrontherapy: collaborator
• Laura Deborah Locati: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• Azienda Ospedaliero Universitaria di Sassari: collaborator

Study Sites (5)

Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale

Naples, Italy, 80131, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, 27100, Italy

RECRUITING

Istituti Clinici Scientifici Maugeri

Pavia, Italy, 27100, Italy

RECRUITING

National Center of Adrotherapy Oncology

Pavia, Italy, 27100, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Sassari

Sassari, Italy, 07100, Italy

RECRUITING

Related Publications (17)

• 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 BACKGROUND

• 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 Trial). Perioper Med (Lond). 2021 Jun 22;10(1):23. doi: 10.1186/s13741-021-00190-8.

  PMID: 34154675 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Voorn MJJ, Driessen EJM, Reinders RJEF, van Kampen-van den Boogaart VEM, Bongers BC, Janssen-Heijnen MLG. Effects of exercise prehabilitation and/or rehabilitation on health-related quality of life and fatigue in patients with non-small cell lung cancer undergoing surgery: A systematic review. Eur J Surg Oncol. 2023 Oct;49(10):106909. doi: 10.1016/j.ejso.2023.04.008. Epub 2023 May 2.

  PMID: 37301638 BACKGROUND

• Waterland JL, McCourt O, Edbrooke L, Granger CL, Ismail H, Riedel B, Denehy L. Efficacy of Prehabilitation Including Exercise on Postoperative Outcomes Following Abdominal Cancer Surgery: A Systematic Review and Meta-Analysis. Front Surg. 2021 Mar 19;8:628848. doi: 10.3389/fsurg.2021.628848. eCollection 2021.

  PMID: 33816546 BACKGROUND

• Sabajo CR, Ten Cate DWG, Heijmans MHM, Koot CTG, van Leeuwen LVL, Slooter GD. Prehabilitation in colorectal cancer surgery improves outcome and reduces hospital costs. Eur J Surg Oncol. 2024 Jan;50(1):107302. doi: 10.1016/j.ejso.2023.107302. Epub 2023 Nov 28.

  PMID: 38043359 BACKGROUND

• Molenaar CJL, Minnella EM, Coca-Martinez M, Ten Cate DWG, Regis M, Awasthi R, Martinez-Palli G, Lopez-Baamonde M, Sebio-Garcia R, Feo CV, van Rooijen SJ, Schreinemakers JMJ, Bojesen RD, Gogenur I, van den Heuvel ER, Carli F, Slooter GD; PREHAB Study Group. Effect of Multimodal Prehabilitation on Reducing Postoperative Complications and Enhancing Functional Capacity Following Colorectal Cancer Surgery: The PREHAB Randomized Clinical Trial. JAMA Surg. 2023 Jun 1;158(6):572-581. doi: 10.1001/jamasurg.2023.0198.

  PMID: 36988937 BACKGROUND

• Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.

  PMID: 28489682 BACKGROUND

• Silver JK, Flores LE. Integrating Prehabilitation into the Cancer Survivorship Framework. Eur Urol Focus. 2024 Jan;10(1):23-25. doi: 10.1016/j.euf.2023.11.006. Epub 2023 Nov 22.

  PMID: 37996272 BACKGROUND

• Carli F, Silver JK, Feldman LS, McKee A, Gilman S, Gillis C, Scheede-Bergdahl C, Gamsa A, Stout N, Hirsch B. Surgical Prehabilitation in Patients with Cancer: State-of-the-Science and Recommendations for Future Research from a Panel of Subject Matter Experts. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):49-64. doi: 10.1016/j.pmr.2016.09.002.

  PMID: 27913000 BACKGROUND

• Ligibel JA, Bohlke K, May AM, Clinton SK, Demark-Wahnefried W, Gilchrist SC, Irwin ML, Late M, Mansfield S, Marshall TF, Meyerhardt JA, Thomson CA, Wood WA, Alfano CM. Exercise, Diet, and Weight Management During Cancer Treatment: ASCO Guideline. J Clin Oncol. 2022 Aug 1;40(22):2491-2507. doi: 10.1200/JCO.22.00687. Epub 2022 May 16.

  PMID: 35576506 BACKGROUND

• Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.

  PMID: 23756434 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Motor Activity; Malnutrition

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Behavior; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Laura D Locati, MD, PhD

CONTACT

+39 0382593585; oncologiapavia@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Medical Oncology; Principal Investigator; Clinical Professor

Model Details: There will be two groups of head and neck cancer patients, one undergoing surgery plus (chemo)radiotherapy and the other undergoing definitive concomitant chemo-radiotherapy. Both groups will receive the prehabilitation intervention.

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-10

Locations

IT (5)