NCT04658706: SEHNeCa

The SEHNeCa Supervised Exercise Project

Status unknown NA Last updated 23 July 2021

What this trial tests

NA trial testing A supervised exercise program in Neack and Head Cancer in 120 participants. Status unknown.

Timeline

1 January 2021

Primary endpoint
1 September 2021

1 January 2023

Quick facts

Lead sponsor	Basque Health Service
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	120
Start date	1 January 2021
Primary completion	1 September 2021
Estimated completion	1 January 2023
Sites	1 location across Spain

Drugs / interventions tested

• A supervised exercise program
• exercise prescription

Conditions studied

• Neack and Head Cancer — all drugs for Neack and Head Cancer →
• Supervised Execise Program — all drugs for Supervised Execise Program →

Sponsor

Basque Health Service — full company profile →

Who can join

18 and older, any sex, with Neack and Head Cancer or Supervised Execise Program. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objectives:

* To evaluate the effectiveness and efficiency of an innovative supervised exercise program for patients with head and neck cancer (SEHNeCa) to ameliorate loss of lean body mass, functional capacity and quality of life during one year, compared to a reference group receiving a physical activity prescription to be performed autonomously.
* To identify the optimal timing for applying the supervised exercise program: in a Prehabilitation period, at least 2 weeks before starting the conventional chemoradiotherapy treatment and concomitant with it, or during a Rehabilitation period, starting 12 weeks after the first radiotherapy session, once standard treatment has finished. Design: a multicenter, randomized clinical trial, where patients will be randomized to 3 groups: one control group and 2 experimental with different timing of exercise intervention. Population: 120 patients diagnosed with histological locally advanced stage III-IVa-b with squamous cell carcinomas of the larynx, pharynx, oral cavity, salivary or in neck lymph nodes from an unknown primary tumour treated with curative intent undergoing radiotherapy with or without concomitant chemotherapy.

SEHNeCa program: is a 12-week exercise program supervised by specially trained instructors combining moderate to high intensity aerobic and strength exercises (three 1 hour sessions a week). Outcome measurements: main outcome variable: change in body mass index at 6 months (multy-frecuenciy imoediance). Secondary variables at basal, 7, 12, 25, and 52 weeks after the beginning of radiotherapy include quality of life (general SF-36 and cancer specific quality of life -European Organization for Research and Treatment of Cancer QLQ-C-30-),functional capacity (6 min walking test), patient reported outcomes and treatment maximum adverse events. Analyses: Differences between treatment groups in changes in outcome variables will be analyzed on an intention to treat basis. We will use linear mixed models for longitudinal analysis of repeated measurements of continuous outcomes (SAS PROC MIXED) and generalized logistic mixed models for dichotomous (SAAS PROC GLIMMIX), considering intercept and time courses as random effects and testing the significance of the interaction of time slopes by treatment group.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of exercise across the head and neck cancer continuum: a systematic review of randomized controlled trials.
   Avancini A, Borsati A, Belluomini L, Giannarelli D, et al · · 2023 · cited 17× · PMID 37924500 · DOI 10.1007/s00520-023-08126-2
2. Protocol for the SEHNeCa randomised clinical trial assesing Supervised Exercise for Head and Neck Cancer patients.
   Rodriguez-Arietaleanizbeaskoa M, Mojas Ereño E, Arietaleanizbeaskoa MS, Grandes G, et al · · 2023 · cited 4× · PMID 36964485 · DOI 10.1186/s12885-023-10718-4