Neuropathic PainDIP-CAOSNCT05505188
Predictive and Impact of Pain After 6 Months of Radiotherapy, in Head and Neck Cancer
A study testing Questionnaire in people with Neuropathic Pain and Anxiety Disorder/Anxiety State, run by University Hospital, Caen at 1 site in France.
Trial summary
Head and neck cancers are a source of complications and after-effects related to the disease and treatment. These cancers and their treatment alter the quality of life of patients and generate pain with physical and psychological components. Chronic pain affects 36% of patients at 6 months and 30% after this period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Anxiety Disorder/Anxiety State, Pain, Chronic
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2023to 1 Sep 2026
- 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 with a first Head and neck cancer whose therapeutic sequence involves radiotherapy
- Patient over 18 years of age
- Having given written consent
- patient not previously treated with radiotherapy
- Life expectancy > 3 months
- World Health Organization (WHO) score < 3
Show all 10Show fewer
- Histologically proven Head and Neck cancer
- Stable patient, with no signs of recurrence or other progressive neoplasia at the time of the examination
- Patient treated with radiotherapy
- Patient fluent in French
Who cannot join
- Non-consenting patient
- History of malignancy, other than treated and cured basal cell or cervical cancer
- Patient who has had a salvage surgery other than lymph node removal
- Patient with evidence of recurrence or other progressive neoplasia at the time of examination
- Patient who has had previous mutilating surgery (causing sequelae of swallowing and eating)
- Uncontrolled infectious pathology
Show all 9Show fewer
- Patient under 18 years of age
- Patient who is not fluent in French
- Patient with a psychiatric pathology that could disrupt the study or prevent the interpretation of the results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Predictive and Impact of Pain at 6 Months in Patients Treated With Radiotherapy for Head and Neck Cancer
Head and neck cancers are a source of complications and after-effects related to the disease and treatment. These cancers and their treatment alter the quality of life of patients and generate pain with physical and psychological components. Chronic pain affects 36% of patients at 6 months and 30% after this period. These pains are responsible for the consumption of level II and III analgesics in 53% of these patients. At the same time, after the end of treatment, nearly a quarter of patients continued to smoke and half still consumed alcohol at least twice a week.
The hypothesis of this research is to investigate the correlation between pain and the continuation of addictions, the occurrence of depressive states, asthenia and the alteration of the patients' global quality of life.
Read more
The investigators propose a two-center prospective cohort study to evaluate this hypothesis at 6 months after radiotherapy treatment.
This study is planned to include 120 patients with a first head and neck cancer whit radiotherapy as part of their treatment sequence. The expected duration of inclusion is 18 months.
The identification of factors affecting survival, quality of life and patient compliance is essential to determine appropriate management, particularly by creating appropriate therapeutic education programs.
- Conditions
- Neuropathic Pain, Anxiety Disorder/Anxiety State, Pain, Chronic, Alcohol Use Disorder, Psychoactive Substance Use, Sleep
- Being tested
- Questionnaire
- Keywords
- Head and neck cancer, pain, Quality of life, Addiction, Depression
- Medical subject headings
- Neuralgia, Anxiety Disorders, Chronic Pain, Alcoholism, Signs and Symptoms, Tobacco Use Disorder, Head and Neck Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Self-questionnaires are completed by the patient at the time of this consultation:
- Neuropathic pain: NPSI in screening
- Anxiety/depression: HADS in screening
- Quality of life: EORTC (QLQC30 and H\&N43)
- Fatigue: MFI-20 hese self-questionnaires will be retrieved by the Clinical Research Associate (CRA) for verification.
Depending on the result of the NPSI questionnaire can be completed to better characterize neuropathic pain.
Depending on the result of the HADS, the MADRS questionnaire can be completed to quantify the degree of depression.
Individuals diagnosed with neuropathic pain or other depressive symptoms during the 6-month inclusion period will be referred to and managed by specialized practitioners. This assistance will be indicated in follow-up report
| Study group | Role | What they receive |
|---|---|---|
| Population | Other | no arm, single cohort follow-up Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
change, neuropathic pain 1
Neuropathic Pain Symptom Inventory (NPSI) questionnaire, score 0 to 10, higher scores mean a worse, score 0 to 100, higher scores mean a worse outcome
Measured: Day 0", "Month 6"
Secondary outcomes (11)
change, anxiety/depression
with Hospital Anxiety and Depression Scale (HADS), score 0 to 21, higher scores mean a worse outcome
Measured: Day 0", "Month 6"
change, anxiety/depression 1
Montgomery and Asberg Depression Scale (MADRS) questionnaire, score 0 to 60, higher scores mean a worse outcome
Measured: Day 0", "Month 6"
change, quality of life
QLQC30 questionnaire of Quality of Life, score 30-100, higher scores indicating better outcomes. the questionnaire measures several factors: physical fitness, professional activity, pain, nutrition, secondary effect, psychological and social status.
Measured: Day 0", "Month 6"
change, quality of life 1
H\&N43 questionnaire of Quality of Life, score 43 to 172, higher scores indicating a worse outcomes. The questionnaire measures several factors:secondary effect, self-image, sociability, sexuality.
Measured: Day 0", "Month 6"
change, fatigue
Multidimensional Fatigue Inventory (MFI-20) questionnaire, score 20 to 100, high scores represent more fatigue
Measured: Day 0", "Month 6"
change, symptoms related to head and neck cancer
MD Anderson Symptom Inventory Head and Neck (MDASI-HN) questionnaire, score 0 to 220, higher scores indicating more symptoms
Measured: Day 0", "Month 6"
change, sleep
question about sleep quality 0-10, higher scores indicating better outcomes
Measured: Day 0", "Month 6"
change, the impact of pain
short pain questionnaire in French (QCD), score 0 to 120, high scores represent more impact of pain
Measured: Day 0", "Month 6"
change, Alcohol Use and Consumption Disorder
Diagnostic and statistical manual of mental disorders (5th ed.) (DSM5) , questionnaire, score 0 to 115, high scores represent more disorder
Measured: Day 0", "Month 6"
change use of other psychoactive substances
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) alcool questionnaire, score 0 to 39, high scores represent more addiction
Measured: Day 0", "Month 6"
change severity of nicotine addiction
Fagerström questionnaire, score 0 to 10, high scores represent more addiction
Measured: Day 0", "Month 6"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start13 Mar 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The main objective is to calculate the percentage of patients with neuropathic pain 6 months after the end of the treatments and to analyze the link between this pain and addictions, asthenia, depression, and in a more global way on the quality of life of patients. This evaluation will be done using validated questionnaires and self-questionnaires.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Francois Baclesse
- Responsible party
- Sponsor
- Investigators
- maxime humbert, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505188
- Sponsor's protocol ID
- 2020-A01894-35
- Acronym
- DIP-CAOS
- Status last verified
- Jul 2025
- First submitted
- 14 Mar 2022
- Last updated
- 25 Jul 2025
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive and Impact of Pain at 6 Months in Patients Treated With Radiotherapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05505188
- Acronym / sponsor ID
- DIP-CAOS / 2020-A01894-35
- Conditions
- Neuropathic Pain, Anxiety Disorder/Anxiety State, Pain, Chronic, Alcohol Use Disorder, Psychoactive Substance Use, Sleep
- Keywords
- Head and neck cancer, pain, Quality of life, Addiction, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Centre Francois Baclesse
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 17 Aug 2022 (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.
Head and neck cancers are a source of complications and after-effects related to the disease and treatment. These cancers and their treatment alter the quality of life of patients and generate pain with physical and psychological components. Chronic pain affects 36% of patients at 6 months and 30% after this period. These pains are responsible for the consumption of level II and III analgesics in 53% of these patients. At the same time, after the end of treatment, nearly a quarter of patients continued to smoke and half still consumed alcohol at least twice a week.
The hypothesis of this research is to investigate the correlation between pain and the continuation of addictions, the occurrence of depressive states, asthenia and the alteration of the patients' global quality of life.
The investigators propose a two-center prospective cohort study to evaluate this hypothesis at 6 months after radiotherapy treatment.
This study is planned to include 120 patients with a first head and neck cancer whit radiotherapy as part of their treatment sequence. The expected duration of inclusion is 18 months.
The identification of factors affecting survival, quality of life and patient compliance is essential to determine appropriate management, particularly by creating appropriate therapeutic education programs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The main objective is to calculate the percentage of patients with neuropathic pain 6 months after the end of the treatments and to analyze the link between this pain and addictions, asthenia, depression, and in a more global way on the quality of life of patients. This evaluation will be done using validated questionnaires and self-questionnaires.
| Arm | Type | Receives |
|---|---|---|
| Population | Other | Other: Questionnaireno arm, single cohort follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with a first Head and neck cancer whose therapeutic sequence involves radiotherapy
- Patient over 18 years of age
- Having given written consent
- patient not previously treated with radiotherapy
- Life expectancy > 3 months
Key exclusion criteria (9 listed)
- Non-consenting patient
- History of malignancy, other than treated and cured basal cell or cervical cancer
- Patient who has had a salvage surgery other than lymph node removal
- Patient with evidence of recurrence or other progressive neoplasia at the time of examination
- Patient who has had previous mutilating surgery (causing sequelae of swallowing and eating)
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 |
|---|---|---|
| QuestionnaireSelf-questionnaires are completed by the patient at the time of this consultation: * Neuropathic pain: NPSI in screening * Anxiety/depression: HADS in screening * Quality of life: EORTC (QLQC30 and H\&N43) * Fatigue: MFI-20 hese self-questionnaires will be retrieved by the Clinical Research Associate (CRA) for verification. Depending on the result of the NPSI questionnaire can be completed to better characterize neuropathic pain. Depending on the result of the HADS, the MADRS questionnaire can be completed to quantify the degree of depression. Individuals diagnosed with neuropathic pain or other depressive symptoms during the 6-month inclusion period will be referred to and managed by specialized practitioners. This assistance will be indicated in follow-up report | Other | Population |
Primary outcome
change, neuropathic pain 1
Time frame: Day 0", "Month 6"
Neuropathic Pain Symptom Inventory (NPSI) questionnaire, score 0 to 10, higher scores mean a worse, score 0 to 100, higher scores mean a worse outcome
11 secondary outcomes
change, anxiety/depression
Time frame: Day 0", "Month 6"
change, anxiety/depression 1
Time frame: Day 0", "Month 6"
change, quality of life
Time frame: Day 0", "Month 6"
change, quality of life 1
Time frame: Day 0", "Month 6"
change, fatigue
Time frame: Day 0", "Month 6"
change, symptoms related to head and neck cancer
Time frame: Day 0", "Month 6"
change, sleep
Time frame: Day 0", "Month 6"
change, the impact of pain
Time frame: Day 0", "Month 6"
change, Alcohol Use and Consumption Disorder
Time frame: Day 0", "Month 6"
change use of other psychoactive substances
Time frame: Day 0", "Month 6"
change severity of nicotine addiction
Time frame: Day 0", "Month 6"
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 25 Jul 2025.
- 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.
maxime humbert, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Neuropathic Pain and Anxiety Disorder/Anxiety State, run by University Hospital, Caen 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 10 inclusion and 9 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 25 Jul 2025. 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 Maxime Humbert, MD (0231064640 ext. +33, humbert-m@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change, neuropathic pain 1 (time frame: Day 0", "Month 6"). 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 25 Jul 2025.