Clinical trial NCT05418842: Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial
Official title: Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Neoplasms
Keywords: Prehabilitation
Exercise
Head and Neck Cancer
Lead sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
Sponsor class: OTHER
Collaborators: name: Research Center in Sports Sciences, Health Sciences and Human Development
name: University Institute of Maia
name: Aveiro University
name: Centro Hospitalar de Vila Nova de Gaia/Espinho
First posted: 2022-06-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old;
* Histologically confirmed HNSCC located on the oral cavity, larynx, oropharynx, hypopharynx, nasopharynx or in lymph nodes from an unknown primary tumor (stage I-IV);
* Proposed for concomitant chemoradiotherapy with curative intent;
* Date of treatment beginning ≥2 weeks from baseline assessment;
* ECOG-Performance Status 0-1.

Exclusion Criteria:

* Completion of previous anticancer treatment within less than a year;
* Uncontrolled hypertension, cardiac or pulmonary disease;
* Contraindications to exercise training;
* Inability to provide informed consent;
* Expected inability to fulfil the proposed schedule.

Primary outcomes:
measure: Functional Capacity
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Secondary outcomes:
measure: Functional Capacity
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: Isometric Handgrip Muscle Strength
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
measure: Isometric Handgrip Muscle Strength
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: Arterial Stiffness
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
measure: Arterial Stiffness
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: Endothelial Function
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
measure: Endothelial Function
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: Lower Limb Functionality
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
measure: Lower Limb Functionality
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: Health-related Quality of Life
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
measure: Health-related Quality of Life
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: Head and Neck Cancer-specific Quality of Life
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
measure: Head and Neck Cancer-specific Quality of Life
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: Body Weight
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
measure: Body Weight
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: Body Mass Index
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
measure: Body Mass Index
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: Muscle Mass
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
measure: Muscle Mass
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: Percentage of Body Fat
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
measure: Percentage of Body Fat
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: C-Reactive Protein
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
measure: C-Reactive Protein
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: Albumin
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
measure: Albumin
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: Hemogram
timeFrame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
measure: Hemogram
timeFrame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
measure: Unplanned hospital visits
timeFrame: From baseline to 4 Weeks after last radiotherapy session
measure: Compliance to Chemotherapy
timeFrame: Through chemotherapy completion, an average of 7 weeks
measure: Compliance to Radiotherapy
timeFrame: Through radiotherapy completion, an average of 7 weeks
measure: Treatment-Related Adverse Events
timeFrame: From the beginning of radiotherapy/chemotherapy to 4 Weeks after last radiotherapy session
measure: Progression-Free Survival
timeFrame: From baseline to 5 years after diagnosis
measure: Overall Survival
timeFrame: From baseline to 5 years after diagnosis
Other outcomes:
Locations:
city: Maia
country: Portugal
facility: University of Maia
state: Porto
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia/Espinho
state: Porto
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto (IPO-Porto)
state: Região
city: Aveiro
country: Portugal
facility: University of Aveiro
city: Porto
country: Portugal
facility: Liga Portuguesa Contra o Cancro - Núcleo Regional do Norte (LPCC-NRN)
Study officials:
affiliation: Research Center of Sports Science Health Science and Human Development - University of Maia
name: Catarina Garcia, Msc
role: PRINCIPAL_INVESTIGATOR
References: