Effect of Physical Activity Program on Sedentary of Patients With Upper Aerodigestive Tract Cancer

Head and Neck Cancer Clinical Trial

— APAORL2  

Official title:

Effect of Physical Activity Program on Sedentary and Physical Activity Level of Patients With Upper Aerodigestive Tract Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06184880
• Other study ID #: RIPH-CHV-14
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier de Valence
• Contact: Guillaume Buiret
• Phone: +33475752555
• Email: gbuiret[@]ch-valence.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

APAORL2 study aims to evaluate the efficacy of a physical activity program on the sedentary and physical activity level during the 18-month program.

APAORL2 study is a randomized, open label, controlled, monocentric, intervention study that will be conducted among 96 patients treated for localized upper aerodigestive tract cancer.

Description:

Rationale:

A sedentary lifestyle has been clearly shown to reduce survival in cancer patients, mainly through metabolic changes. While the notions of sedentary lifestyle and physical inactivity overlap, they are not entirely synonymous.

The aim of this study is to examine the contribution of a physical activity program, during the treatment and post-treatment phases, in addition to the current care program, on behavior change (i.e. sedentary behaviors and Physical activity levels), quality of life and fatigue in patients with upper aerodigestive tract cancer

The primary objective is to show that the experimental group (combining the current care pathway + physical Activity program) has lower levels of sedentary behaviour and higher levels of physical activity than the control group (following the classic care pathway with Physical Activity awareness) after the treatment phase.

Patients will be randomly assigned to one of the 2 arms of the study according to a 1:1 ratio:

Group A: control group: standard care with recommendations on physical activity.

Group B: experimental group: Physical activity program

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: December 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients =18 years

• newly diagnosed, histologically proven Upper Aerodigestive Tract Cancer, non-metastatic,

• life expectancy =18 months

• having a smartphone, tablet or computer with an internet connection enabling remote physical Activity sessions for the experimental group

Exclusion Criteria:

• Presenting a contraindication to moderate physical activity

• Deprived of their liberty by court or administrative decision

• Unable to be followed for medical, social, family, geographic or psychological reasons for the duration of the study,

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Upper Aerodigestive Tract Cancer

Intervention

Behavioral:
• behavioral
International Physical Activity (IPAQ) Questionnaire, Quality of Life Questionnaire QLQ-C30, HN 43 questionnaire, Multidimensional Fatigue Inventory (MFI) Questionnaire, Big Five Inventory Questionnaire, illness Identity Questionnaire,

Other:
• Sedentary
Actimetry (cumulative time without movement over 24h, prolonged sedentary periods >30 min without movement. Continuous recording 7 days prior to visit T0, T1, T2, T3, T4, T5

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier de Valence	Claude Bernard University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sedentary level	cumulative time without movement over a day, as well as prolonged sedentary periods (>30min without movement): continuous recording 7 days prior to hospital visits	Change between baseline and 3, 6, 12 months and 18 months
Secondary	International Physical Activity Questionnaire	Physical Activity level	Change between baseline and 3, 6, 12 months and 18 months
Secondary	Quality of Life Questionnaire QLQ-C30	Quality of Life	Change between baseline and 3, 6, 12 months and 18 months
Secondary	Head Neck (HN) 43 questionnaire	Quality of Life	Change between baseline and 3, 6, 12 months and 18 months
Secondary	Multidimensional Fatigue Inventory: MFI questionnaire	fatigue level	Change between baseline and 3 months
Secondary	Big Five Inventory questionnaire	measure personality traits.	Change between baseline and 3 months