Head and Neck CancerHNCANCERFITNCT06593639
Effect of Prehabilitation on Head and Neck Cancer Patients
A study testing Prehabilitation before surgery and Prehabilitation before and during CRT in people with Head and Neck Cancer, run by Laura Deborah Locati at 5 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Prehabilitation before surgery and Prehabilitation before and during CRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesItaly
- Study dates
- 9 Sep 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale
Naples, Italy, 80131
Francesco Perri, +39 08117770403, f.perri@istitutotumori.na.it
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Marco Benazzo, +39 0382 503740, segr.otorino@smatteo.pv.it
- Recruiting
Istituti Clinici Scientifici Maugeri
Pavia, Italy, 27100
Laura D Locati, MD, PhD, +390382593585, oncologiapavia@icsmaugeri.it
Laura D Locati, MD, PhD
- Recruiting
National Center of Adrotherapy Oncology
Pavia, Italy, 27100
Rossana Ingargiola, +39 0382078501, segreteriaclinica@cnao.it
- Recruiting
Azienda Ospedaliero Universitaria di Sassari
Sassari, Italy, 07100
Davide Rizzo, +39 0792061586, segreteria.oncologia.ssa@aousassari.it
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Prehabilitation before surgery, Prehabilitation before and during CRT
- Keywords
- head and neck cancer, prehabilitation, physical exercise, malnutrition, nutritional intervention, psychological support, cisplatin, hadrontherapy, ENT surgery
- Medical subject headings
- Head and Neck Neoplasms, Motor Activity, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation before surgeryOther
Also called physical exercise, nutritional intervention, psychological support
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.
Prehabilitation before and during CRTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery plus (chemo)radiotherapy | Experimental | Head and neck cancer patients undergoing surgery before (chemo)radiotherapy according to stage and risk factors. Receives: Other: Prehabilitation before surgery |
| Chemo-radiotherapy | Experimental | Head and neck cancer patients undergoing definitive concomitant chemo-radiotherapy (CRT) according to stage and risk factors. Receives: Other: Prehabilitation before and during CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From the enrollment to 6 months after the end of the oncological treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Sep 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laura Deborah Locati
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Ospedaliero Universitaria di Sassari, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, CNAO National Center of Oncological Hadrontherapy
- Responsible party
- Sponsor-investigator, Laura Deborah Locati, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593639
- Sponsor's protocol ID
- PNRR-TR1-2023-12377022
- Other IDs
- PNRR-TR1-2023-12377022
- Acronym
- HNCANCERFIT
- Status last verified
- Oct 2025
- First submitted
- 6 Sep 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35913625Loughney 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.
PubMed 34154675Urvaylioglu 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.
PubMed 33639454Halkett 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.
PubMed 29855611Goldsmith 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.
PubMed 33554075Quist 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.
PubMed 32416432Lippi 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.
PubMed 37760472Howe 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.
PubMed 38457236Voorn 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.
PubMed 37301638Waterland 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.
PubMed 33816546Sabajo 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.
PubMed 38043359Molenaar 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.
PubMed 36988937Barberan-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.
PubMed 28489682Silver 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.
PubMed 37996272Carli 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.
PubMed 27913000
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06593639
- Acronym / sponsor ID
- HNCANCERFIT / PNRR-TR1-2023-12377022
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer, prehabilitation, physical exercise, malnutrition, nutritional intervention, psychological support, cisplatin, hadrontherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Laura Deborah LocatiUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Ospedaliero Universitaria di Sassari, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, CNAO National Center of Oncological Hadrontherapy
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Surgery plus (chemo)radiotherapy | Experimental | Other: Prehabilitation before surgeryHead and neck cancer patients undergoing surgery before (chemo)radiotherapy according to stage and risk factors. |
| Chemo-radiotherapy | Experimental | Other: Prehabilitation before and during CRTHead and neck cancer patients undergoing definitive concomitant chemo-radiotherapy (CRT) according to stage and risk factors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation before surgeryAlso: physical exercise, nutritional intervention, psychological supportPrehabilitation 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. | Other | Surgery plus (chemo)radiotherapy |
| Prehabilitation before and during CRTPrehabilitation 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. | Other | Chemo-radiotherapy |
Primary outcome
Feasibility of multimodal prehabilitation
Time frame: From enrollment to the end of prehabilitation program, 2 weeks after the end of curative treatment
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.
Efficacy of multimodal prehabilitation
Time frame: From enrollment to 2 weeks after the end of oncological treatment
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.
Cost-effectiveness of multimodal prehabilitation
Time frame: From the enrollment to 6 months after the end of the oncological treatment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 35913625Cantwell 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.
- Background: PubMed 34154675Loughney 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.
- Background: PubMed 33639454Urvaylioglu 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.
- Background: PubMed 29855611Halkett 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.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation before surgery and Prehabilitation before and during CRT in people with Head and Neck Cancer, run by Laura Deborah Locati at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura D Locati, MD, PhD (+39 0382593585, oncologiapavia@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of multimodal prehabilitation (time frame: From enrollment to the end of prehabilitation program, 2 weeks after the end of curative treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06593639, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.