The SEHNeCa Supervised Exercise Project

NCT04658706 | Unknown

• 1 other identifier: PI 20/00112
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in body lean mass

  change in body lean mass will be measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy) by the multi-frequency impedance measurement technique.

  Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy

Secondary Outcomes (6)

• Change in Quality of life

  Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy

• Change in Functional capacity

  Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy

• Change in Strenght

  Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy

• Change in Quality of life

  Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy

• Change in Functional capacity

  Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy

Study Arms (3)

Control

SHAM COMPARATOR

a physical activity prescription to be performed autonomously

Other: exercise prescription

Prehabilitation

EXPERIMENTAL

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

Other: A supervised exercise program

Rehabilitation

EXPERIMENTAL

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

Other: A supervised exercise program

Interventions

A supervised exercise program 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).

Prehabilitation; Rehabilitation

exercise prescription OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Basque Health Service: lead

Study Sites (1)

Biocruces Bizkaia research health institute

Barakaldo, Bizkaia, Spain

Location

Related Publications (1)

• 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.

  PMID: 36964485 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 8, 2020
• Study Start: January 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: January 1, 2023
• Last Updated: July 23, 2021

Record last verified: 2021-02

Locations

ES (1)