Trial Title:
Effect of Prehabilitation on Head and Neck Cancer Patients
NCT ID:
NCT06593639
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
head and neck cancer
prehabilitation
physical exercise
malnutrition
nutritional intervention
psychological support
cisplatin
hadrontherapy
ENT surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Prehabilitation before surgery
Description:
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.
Arm group label:
Surgery plus (chemo)radiotherapy
Other name:
physical exercise
Other name:
nutritional intervention
Other name:
psychological support
Intervention type:
Other
Intervention name:
Prehabilitation before and during CRT
Description:
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.
Arm group label:
Chemo-radiotherapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesco Perri
Phone:
+39 08117770403
Email:
f.perri@istitutotumori.na.it
Facility:
Name:
Fondazione IRCCS Policlinico San Matteo
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Marco Benazzo
Phone:
+39 0382 503740
Email:
segr.otorino@smatteo.pv.it
Facility:
Name:
Istituti Clinici Scientifici Maugeri
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Laura D Locati, MD, PhD
Phone:
+390382593585
Email:
oncologiapavia@icsmaugeri.it
Contact backup:
Last name:
Laura D Locati, MD, PhD
Facility:
Name:
National Center of Adrotherapy Oncology
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Rossana Ingargiola
Phone:
+39 0382078501
Email:
segreteriaclinica@cnao.it
Facility:
Name:
Azienda Ospedaliero Universitaria di Sassari
Address:
City:
Sassari
Zip:
07100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Davide Rizzo
Phone:
+39 0792061586
Email:
segreteria.oncologia.ssa@aousassari.it
Start date:
September 9, 2024
Completion date:
August 2026
Lead sponsor:
Agency:
Laura Deborah Locati
Agency class:
Other
Collaborator:
Agency:
Fondazione IRCCS Policlinico San Matteo di Pavia
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliero Universitaria di Sassari
Agency class:
Other
Collaborator:
Agency:
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Agency class:
Other
Collaborator:
Agency:
CNAO National Center of Oncological Hadrontherapy
Agency class:
Other
Source:
Istituti Clinici Scientifici Maugeri SpA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06593639
