The SEHNeCa Supervised Exercise Project

NCT ID: NCT04658706

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-01-01

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.

Conditions

Neack and Head Cancer; Supervised Execise Program

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control

a physical activity prescription to be performed autonomously

Group Type: SHAM_COMPARATOR

exercise prescription

Intervention Type: OTHER

they will receive a prescription concerning healthy lifestyles and a personalized exercise plan

Prehabilitation

They will receive a supervised exercise programat least 2 weeks before starting the conventional chemoradiotherapy treatment and concomitant

Group Type: EXPERIMENTAL

A supervised exercise program

Intervention Type: OTHER

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).

Rehabilitation

They will receive a supervised exercise programat 12 weeks after the first radiotherapy session, once standard treatment has finished

Group Type: EXPERIMENTAL

A supervised exercise program

Intervention Type: OTHER

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).

Interventions

A supervised exercise 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).

Intervention Type: OTHER

exercise prescription

they will receive a prescription concerning healthy lifestyles and a personalized exercise plan

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basque Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jon Cacicedo Fernandez Bobadilla

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Biocruces Bizkaia research health institute

Barakaldo, Bizkaia, Spain

Countries

Spain

References

Rodriguez-Arietaleanizbeaskoa M, Mojas Ereno E, Arietaleanizbeaskoa MS, Grandes G, Rodriguez Sanchez A, Urquijo V, Hernando Alday I, Dublang M, Angulo-Garay G, Cacicedo J; SEHNeCa group. Protocol for the SEHNeCa randomised clinical trial assesing Supervised Exercise for Head and Neck Cancer patients. BMC Cancer. 2023 Mar 24;23(1):271. doi: 10.1186/s12885-023-10718-4.

Reference Type: DERIVED

PMID: 36964485 (View on PubMed)

Other Identifiers

PI 20/00112

Identifier Type: -

Identifier Source: org_study_id