Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial

Associacao de Investigacao de Cuidados de Suporte em Oncologia5 sites in 1 country46 target enrollmentJune 1, 2021

ConditionsHead and Neck Neoplasms

Overview

Phase: N/A
Intervention: Not specified
Conditions: Head and Neck Neoplasms
Sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
Enrollment: 46
Locations: 5
Primary Endpoint: Functional Capacity
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 1, 2021

End Date

July 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Associacao de Investigacao de Cuidados de Suporte em Oncologia

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Functional Capacity

Time Frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

Assessed by six-minute walk test.

Secondary Outcomes

Functional Capacity(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
Unplanned hospital visits(From baseline to 4 Weeks after last radiotherapy session)
Compliance to Chemotherapy(Through chemotherapy completion, an average of 7 weeks)
Compliance to Radiotherapy(Through radiotherapy completion, an average of 7 weeks)
Overall Survival(From baseline to 5 years after diagnosis)
Arterial Stiffness(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
Endothelial Function(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
Lower Limb Functionality(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
Health-related Quality of Life(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
Body Weight(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
Percentage of Body Fat(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
C-Reactive Protein(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
Albumin(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
Hemogram(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
Isometric Handgrip Muscle Strength(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
Head and Neck Cancer-specific Quality of Life(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
Muscle Mass(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
Body Mass Index(Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session)
Treatment-Related Adverse Events(From the beginning of radiotherapy/chemotherapy to 4 Weeks after last radiotherapy session)
Progression-Free Survival(From baseline to 5 years after diagnosis)