Clinical trial · Interventional
Effect of Prehabilitation on Head and Neck Cancer Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation before and during CRT | Other | — | UNRESOLVED |
| Prehabilitation before surgery | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surgery plus (chemo)radiotherapy
- description
- Head and neck cancer patients undergoing surgery before (chemo)radiotherapy according to stage and risk factors.
- interventionNames
- Other: Prehabilitation before surgery
- type
- EXPERIMENTAL
- label
- Chemo-radiotherapy
- description
- Head and neck cancer patients undergoing definitive concomitant chemo-radiotherapy (CRT) according to stage and risk factors.
- interventionNames
- Other: Prehabilitation before and during CRT
Primary outcomes (3)
- measure
- Feasibility of multimodal prehabilitation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (17)
- BACKGROUNDCantwell 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
- BACKGROUNDLoughney 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
- BACKGROUNDUrvaylioglu 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
- BACKGROUNDHalkett 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
- BACKGROUNDGoldsmith 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
- BACKGROUNDQuist 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.