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NCT Number: NCT06184880

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ch Valence

Valence, 26000, France

Location status: Recruiting

Location contact

Guillaume BUIRET, PHD

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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,

Sedentary

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

Other names: Physical Activity level

Primary outcomes

  1. sedentary level

    Time frame: Change between baseline and 3, 6, 12 months and 18 months

    cumulative time without movement over a day, as well as prolonged sedentary periods (>30min without movement): continuous recording 7 days prior to hospital visits

Secondary outcomes

  1. International Physical Activity Questionnaire

    Time frame: Change between baseline and 3, 6, 12 months and 18 months

    Physical Activity level

  2. Quality of Life Questionnaire QLQ-C30

    Time frame: Change between baseline and 3, 6, 12 months and 18 months

    Quality of Life

  3. Head Neck (HN) 43 questionnaire

    Time frame: Change between baseline and 3, 6, 12 months and 18 months

    Quality of Life

  4. Multidimensional Fatigue Inventory: MFI questionnaire

    Time frame: Change between baseline and 3 months

    fatigue level

  5. Big Five Inventory questionnaire

    Time frame: Change between baseline and 3 months

    measure personality traits.

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume Buiret

CONTACT

[email protected]

+33475752555

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Valence

Other

Collaborators

  • Claude Bernard University

Registry information

Official study title

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

Acronym: APAORL2

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Dec 28, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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