Clinical trial NCT06593639: Effect of Prehabilitation on Head and Neck Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
prehabilitation
physical exercise
malnutrition
nutritional intervention
psychological support
cisplatin
hadrontherapy
ENT surgery
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Azienda Ospedaliero Universitaria di Sassari
name: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
name: CNAO National Center of Oncological Hadrontherapy
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of multimodal prehabilitation
timeFrame: From enrollment to the end of prehabilitation program, 2 weeks after the end of curative treatment
measure: Efficacy of multimodal prehabilitation
timeFrame: From enrollment to 2 weeks after the end of oncological treatment
measure: Cost-effectiveness of multimodal prehabilitation
timeFrame: From the enrollment to 6 months after the end of the oncological treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri
city: Pavia
country: Italy
facility: National Center of Adrotherapy Oncology
city: Sassari
country: Italy
facility: Azienda Ospedaliero Universitaria di Sassari
Study officials:
References:
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