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

NCT ID: NCT06184880

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-12-01

Brief 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.

Detailed 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

Conditions

Upper Aerodigestive Tract Cancer; Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

A control group

Patients will receive standard care, recommendations on physical activity.

patients should wear the wristband continuously for 7 days prior to scheduled hospital visit T0, T1, T2, T3, T4, T5

Group Type: ACTIVE_COMPARATOR

behavioral

Intervention Type: 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,

Sedentary

Intervention Type: OTHER

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

B experimental Group

1 or 2 physical activity sessions per week, either face-to-face or by videoconference at patient convenience: low-to-moderate intensity aerobic and anaerobic muscle-strengthening session and a 40-minute stretching/yoga session.

patients should wear the wristband continuously for 7 days prior to scheduled hospital visit T0, T1, T2, T3, T4, T5

Group Type: EXPERIMENTAL

behavioral

Intervention Type: 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,

Sedentary

Intervention Type: OTHER

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

Interventions

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,

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

Other Intervention Names

Physical Activity level

Eligibility Criteria

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,

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

Sponsors

Claude Bernard University

OTHER

Sponsor Role: collaborator

Centre Hospitalier de Valence

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Guillaume

Role: PRINCIPAL_INVESTIGATOR

CH VALENCE

Central Contacts

Guillaume Buiret

Role: CONTACT

gbuiret@ch-valence.fr

+33475752555

Other Identifiers

RIPH-CHV-14

Identifier Type: -

Identifier Source: org_study_id