NCT Number: NCT06593639
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.
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All sexes
Interventional
Not applicable
Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale, Naples, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: physical exercise, nutritional intervention, psychological support
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Laura Deborah Locati
Other
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
Acronym: HNCANCERFIT
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