Clinical trial NCT04658706: The SEHNeCa Supervised Exercise Project
Official title: Supervised Exercise for Head and Neck Cancer Patients Initiated Previously or After Treatment: the SEHNeCa Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neack and Head Cancer
Supervised Execise Program
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2020-12-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Histological diagnosed 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 (TNM 9th AJCC classification; 2019.) treated with curative intent undergoing radiotherapy with or without concomitant chemotherapy (with or without previous surgery).

* Age: more than 18 years
* WHO performance status of 0-1 (IK 80%)
* Body mass index: more than 18.5.
* No evidence of metastatic disease
* No excessive alcohol intake (men \> 21 and women \> 14 units/week)
* No current or previous malignancies that could prevent participation and training
* No recent systematic resistance training.

Exclusion Criteria:

* Decompensated heart disease, uncontrolled hypertension (TAS\>200 o TAD\>110), cardiac insufficiency (NYHA II o mayor), heart failure or constrictive pericarditis, Neutropenia, severe anemia ( Hb\<8.0 g/dl), platelets count \<50.000 microL
* Other health problems in which exercise is contraindicated.
* Carry out physical activity regularly (150 min/week of moderate activity or 75 of vigorous activity), measured with the PVS questionarie.
* Pregnancy
* Tracheostomy.

Primary outcomes:
measure: Change in body lean mass
timeFrame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Secondary outcomes:
measure: Change in Quality of life
timeFrame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
measure: Change in Functional capacity
timeFrame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
measure: Change in Strenght
timeFrame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
measure: Change in Quality of life
timeFrame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
measure: Change in Functional capacity
timeFrame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
measure: Change in Functional capacity
timeFrame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Other outcomes:
Locations:
city: Barakaldo
country: Spain
facility: Biocruces Bizkaia research health institute
state: Bizkaia
Study officials:
References: