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The main purpose of this randomized-controlled trial is to evaluate the effects of prehabilitation based on exercise training (ET) on functional capacity in HNC patients treated with chemoradiotherapy (CRT). Forty-six participants will be randomized (1:1 ratio) into prehabilitation and usual care groups. The length of intervention will be at least 2 weeks. Data will be collected at diagnosis, immediately before anti-cancer treatment start and 4 weeks following CRT. Primary outcome is functional capacity as assessed by the six-minute walk test. Additional measures include muscle strength, endothelial function, arterial stiffness, inflammatory biomarkers, body composition, quality of life, treatment tolerance, compliance to treatment, progression-free survival, and overall survival.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Maia
Maia, Porto District, Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Porto District, Portugal
Instituto Português de Oncologia do Porto (IPO-Porto)
Porto, Região, Portugal
University of Aveiro
Aveiro, Portugal
Liga Portuguesa Contra o Cancro - Núcleo Regional do Norte (LPCC-NRN)
Porto, Portugal
Start Date
June 1, 2021
Primary Completion Date
December 31, 2024
Completion Date
July 31, 2025
Last Updated
August 5, 2024
46
ESTIMATED participants
Prehabilitation
OTHER
Lead Sponsor
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Collaborators
NCT06998069
NCT06912087
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06303180