Upper Aerodigestive Tract CancerAPAORL2NCT06184880
Effect of Physical Activity Program on Sedentary of Patients With Upper Aerodigestive Tract Cancer
A study testing behavioral and Sedentary in people with Upper Aerodigestive Tract Cancer and Head and Neck Cancer, run by Centre Hospitalier de Valence at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Aerodigestive Tract Cancer, Head and Neck Cancer
- What is being tested?
- behavioral and Sedentary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2024to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Ch Valence
Valence, 26000
Guillaume BUIRET, PHD, gbuiret@ch-valence.fr
About this study
Official title: Effect of Physical Activity Program on Sedentary and Physical Activity Level 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.
Read the 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
- Being tested
- behavioral, Sedentary
- Keywords
- Physical Activity, head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioralBehavioural
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,
SedentaryOther
Also called Physical Activity level
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
| Study group | Role | What they receive |
|---|---|---|
| A control group | Active comparator | 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 Receives: Behavioral: behavioral; Other: Sedentary |
| B experimental Group | Experimental | 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 Receives: Behavioral: behavioral; Other: Sedentary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change between baseline and 3, 6, 12 months and 18 months
Secondary outcomes (5)
International Physical Activity Questionnaire
Physical Activity level
Measured: Change between baseline and 3, 6, 12 months and 18 months
Quality of Life Questionnaire QLQ-C30
Quality of Life
Measured: Change between baseline and 3, 6, 12 months and 18 months
Head Neck (HN) 43 questionnaire
Quality of Life
Measured: Change between baseline and 3, 6, 12 months and 18 months
Multidimensional Fatigue Inventory: MFI questionnaire
fatigue level
Measured: Change between baseline and 3 months
Big Five Inventory questionnaire
measure personality traits.
Measured: Change between baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start19 Mar 2024
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Aerodigestive Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized, open label, controlled, monocentric, study
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valence
- Sponsor type
- University, hospital or other
- Collaborators
- Claude Bernard University
- Responsible party
- Sponsor
- Investigators
- Guillaume Guillaume, Principal investigator, CH VALENCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184880
- Sponsor's protocol ID
- RIPH-CHV-14
- Acronym
- APAORL2
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Activity Program on Sedentary and Physical Activity Level of Patients With Upper Aerodigestive Tract Cancer
- ClinicalTrials.gov ID
- NCT06184880
- Acronym / sponsor ID
- APAORL2 / RIPH-CHV-14
- Keywords
- Physical Activity, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Centre Hospitalier de ValenceUniversity, hospital or other
- Collaborators
- Claude Bernard University
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a randomized, open label, controlled, monocentric, study
| Arm | Type | Receives |
|---|---|---|
| A control group | Active comparator | Behavioral: behavioral, Other: SedentaryPatients 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 |
| B experimental Group | Experimental | Behavioral: behavioral, Other: Sedentary1 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioralInternational 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, | Behavioural | A control group, B experimental Group |
| SedentaryAlso: Physical Activity levelActimetry (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 | A control group, B experimental Group |
Primary outcome
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
5 secondary outcomes
International Physical Activity Questionnaire
Time frame: Change between baseline and 3, 6, 12 months and 18 months
Quality of Life Questionnaire QLQ-C30
Time frame: Change between baseline and 3, 6, 12 months and 18 months
Head Neck (HN) 43 questionnaire
Time frame: Change between baseline and 3, 6, 12 months and 18 months
Multidimensional Fatigue Inventory: MFI questionnaire
Time frame: Change between baseline and 3 months
Big Five Inventory questionnaire
Time frame: Change between baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume Guillaume principal investigator
CH VALENCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral and Sedentary in people with Upper Aerodigestive Tract Cancer and Head and Neck Cancer, run by Centre Hospitalier de Valence at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Buiret (+33475752555, gbuiret@ch-valence.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sedentary level (time frame: Change between baseline and 3, 6, 12 months and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.