Head CancerOCAPANCT04673981
Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients (OCAPA)
A study testing diagnostic tes for neuropathic pain in people with Head Cancer and Neck Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Following preliminary studies carried out in our department on these subject and subjective findings during clinical examinations, it has been shown that pain is a symptom that is rarely reported following treatment. Instead, neurosensory disorders such as hypoesthesia and paresthesia are found. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Cancer, Neck Cancer, Chronic Pain
- What is being tested?
- diagnostic tes for neuropathic pain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2020to Jul 2028
- 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
- Patient treated for an oral cavity and oropharynx tumor from at least one year and maximum five years.
- Women or men upper 18 years old)
- Patient with full consent, aware and signed
- Patient cover by the French social security system
Who cannot join
- Patient with mental disorder, psychologic, with a defect of comprehension to agree fully the protocol
- Pregnant women or nursing
- Patients who can't comply with the protocol
- Participation refusal
- Inable full age patient or under judicial protection
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
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Nathalie PHAM DANG, 04 73 750 102, nphamdang@chu-clermontferrand.fr
Nathalie PHAM DANG
About this study
Official title: Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients
Following preliminary studies carried out in our department on these subject and subjective findings during clinical examinations, it has been shown that pain is a symptom that is rarely reported following treatment. Instead, neurosensory disorders such as hypoesthesia and paresthesia are found.
The objective of the study is to map and qualitatively evaluate neurosensory disorders in patients treated for cancers of the oral cavity and oropharynx.
Read the detailed description
The protocol, which is done during the usual follow-up consultation of the patient by the maxillo-facial surgeon, is divided into 3 parts:
PART 1: Collection of Data and Consent
- Patient Data:
- Date of visit and inclusion in the study
- Patient initials
- Age
- Gender (male or female)
- The weight
- The size
- Verification of inclusion and non-inclusion criteria:
- General patient history:
- Patient history
- Ongoing Treatments
- Professional activity
- Tumor:
- Features
- Location
- TNM
- Histological type
- Search for risk factors for peripheral neuropathy
- Check for symptoms of peripheral neuropathy.
PART 2: Collecting Treatment Data
- Operating data:
- Operation date
- Type of surgery
- Duration of surgery
- Severed sensory nerves
- Perioperative complications
- On the way out:
- Adjuvant treatment including radiotherapy and/or chemotherapy.
- Exit analgesic treatment
- EN (Numerical Scale)
PART 3: Collection of data related to neurosensory disorders and pain
- Analgesics consumed
- Questionnaire DN4 for each operated area separated according to the curage, lumpectomy and reconstruction if they take place.
- If DN4 positive, completion of the QCD and QEDN questionnaires.
- Clinical examination for sensory disturbances reported on a chart.
- Generic quality of life questionnaire adapted to cancer pathology EORTC QLQC30 and its specific Head and Neck35 add-on module adapted to head and neck cancers.
- Thermotest and hot water, cold water (for the oral cavity)
- HADS Questionnaire
- Catastrophe Questionnaire
- Quantitative sensory testing (QST) for neuropathic patients :
Mechanical neurosensory disorders will be tested with the Von frey filament and the brush.
- Hypoesthesia or mechanical anaesthesia will be sought with the Von Frey filament and the brush.
- Mechanical hypersensitivity, a painful sensation exacerbated by a sharp, non-traumatic object, will be sought with a large calibre Von Frey filament.
- Static Allodynia, felt painful on contact, will be sought at Von Frey's filament.
- Dynamic Allodynia, felt painful when rubbed, will be sought with a wide brush (8 mm) over a distance of several centimetres.
Thermal neurosensory disorders will be sought for the skin with the Thermotest and at the level of the oral cavity with the application of standardised test tubes containing water at 4°C stored in the fridge or hot water at 63°C (the protocol consists of heating water at 4°C in the microwave for 30 seconds to obtain the temperature of 63°C); these examinations will allow the evaluation of thermal allodynia and hypoesthesia.
The examination will cover the entire face, the oral cavity, the cervical region and the area where the reconstruction flaps are taken. The pathological areas identified will be delimited on diagrams previously made with a coding according to the sensations collected.
- Conditions
- Head Cancer, Neck Cancer, Chronic Pain
- Being tested
- diagnostic tes for neuropathic pain
- Keywords
- Hypoesthesia, Allodynia, Orofacial, Neuropathic pain, cancer
- Medical subject headings
- Head and Neck Neoplasms, Chronic Pain, Hypesthesia, Hyperalgesia, Neuralgia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic tes for neuropathic painDiagnostic test
Thermotest and hot water, cold water (for the oral cavity), Von frey filament and the brush
| Study group | Role | What they receive |
|---|---|---|
| patient treated for a oral cavity and oropharynx cancer | Experimental | questionnaire and tests to evaluate neuropathic pain Receives: Diagnostic Test: diagnostic tes for neuropathic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoesthesia on surgical site using a brush and Von Frey Filament
The measure is a binary measure (positive or negative)
Measured: day 0
anaesthesia on surgical site using a brush and Von Frey Filament
The measure is a binary measure (positive or negative)
Measured: day 0
allodynia on surgical site
The measure is a binary measure (positive or negative) by clinical examination
Measured: day 0
Evaluation of the characteristics of the pain by questionnaire DN4
One standard DN4 with four questions and ten pain characteristics which gave a score from zero to ten points. If DN4 equal or superior of four out of ten the patient seems possible to develop neuropathic pain.
Measured: Day 0
hyperalgesia on surgical site using a brush and Von Frey Filament
The measure is a binary measure (positive or negative)
Measured: Day 0
Evaluation of the characteristics of the pain by questionnaire Neuropathic Pain Symptom Inventory (NPSI)
Twelve questions with a score from zero to ten, zero stands for no pain and ten maximal pain scale. A score is given for burning pain (score out of ten), constriction pain (score out of ten), paroxystic pain (score out of ten), evoked pain (score out of ten), paresthesia (score out of ten) and a total score (out of one hundred)
Measured: Day 0
Evaluation of the characteristics of the pain by questionnaire Brief Pain Inventory
Fifteen questions compose the questionnaire, the first one is a binary answer yes or no, the second one is a schema to localize the pain, thirteen following questions are scaled with a score from zero to ten, zero stands for no pain and ten maximal pain scale
Measured: Day 0
Secondary outcomes (5)
Questionnaire EORTC QLQC30 to assess Quality of life of cancer patients
a score is given for each question, Thirty questions with for each question a score from one (not at all), two (a bit), three (enough) to four (a lot). Two last questions are scale from one (really bad) to seven (excellent)
Measured: day 0
Questionnaire EORTC QLQ-H&N35 to assess Quality of life of head and neck cancer patient
a score is given for 34 questions (with for each question a score from one (not at all), two (a bit), three (enough) to four (a lot)), for the last 5 questions there is a binary scale (1 for no answer and 2 for yes).
Measured: day 0
Quality of life evaluate by the Questionnaire EORTC QLQ-H&N35
a score is given for 34 questions (with for each question a score from one (not at all), two (a bit), three (enough) to four (a lot)), for the last 5 questions there is a binary scale (1 for no answer and 2 for yes)
Measured: Day 0
Pain Catastrophizing Scale (PCS-CF) to assess the catastrophizing
thirteen questions with for each question a score from zero (not at all), one (a bit), two (moderatly), three (a lot) to four (constantly).
A score inferior than thirty mark a moderate risk to develop chronic pain. A score superior than thirty mark a high risk to develop chronic pain.
Measured: Day 0
Anxious and depression disorder screening using questionnaire Hospital Anxiety and Depression scale (HAD)
Fourteen items scaled from zero to three, seven questions refer to anxiety seven others to depressive dimension Both of them gathered to make a score of twenty-one for maximum
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start31 Jul 2020
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie PHAM DANG, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673981
- Sponsor's protocol ID
- RBHP 2020 PHAM DANG
- Other IDs
- 2020-A00476-33
- Acronym
- OCAPA
- Status last verified
- Aug 2025
- First submitted
- 10 Sep 2020
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients
- ClinicalTrials.gov ID
- NCT04673981
- Acronym / sponsor ID
- OCAPA / RBHP 2020 PHAM DANG
- Conditions
- Head Cancer, Neck Cancer, Chronic Pain
- Keywords
- Hypoesthesia, Allodynia, Orofacial, Neuropathic pain, cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 17 Dec 2020 (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.
Following preliminary studies carried out in our department on these subject and subjective findings during clinical examinations, it has been shown that pain is a symptom that is rarely reported following treatment. Instead, neurosensory disorders such as hypoesthesia and paresthesia are found.
The objective of the study is to map and qualitatively evaluate neurosensory disorders in patients treated for cancers of the oral cavity and oropharynx.
Detailed description
The protocol, which is done during the usual follow-up consultation of the patient by the maxillo-facial surgeon, is divided into 3 parts:
PART 1: Collection of Data and Consent
- Patient Data:
- Date of visit and inclusion in the study
- Patient initials
- Age
- Gender (male or female)
- The weight
- The size
- Verification of inclusion and non-inclusion criteria:
- General patient history:
- Patient history
- Ongoing Treatments
- Professional activity
- Tumor:
- Features
- Location
- TNM
- Histological type
- Search for risk factors for peripheral neuropathy
- Check for symptoms of peripheral neuropathy.
PART 2: Collecting Treatment Data
- Operating data:
- Operation date
- Type of surgery
- Duration of surgery
- Severed sensory nerves
- Perioperative complications
- On the way out:
- Adjuvant treatment including radiotherapy and/or chemotherapy.
- Exit analgesic treatment
- EN (Numerical Scale)
PART 3: Collection of data related to neurosensory disorders and pain
- Analgesics consumed
- Questionnaire DN4 for each operated area separated according to the curage, lumpectomy and reconstruction if they take place.
- If DN4 positive, completion of the QCD and QEDN questionnaires.
- Clinical examination for sensory disturbances reported on a chart.
- Generic quality of life questionnaire adapted to cancer pathology EORTC QLQC30 and its specific Head and Neck35 add-on module adapted to head and neck cancers.
- Thermotest and hot water, cold water (for the oral cavity)
- HADS Questionnaire
- Catastrophe Questionnaire
- Quantitative sensory testing (QST) for neuropathic patients :
Mechanical neurosensory disorders will be tested with the Von frey filament and the brush.
- Hypoesthesia or mechanical anaesthesia will be sought with the Von Frey filament and the brush.
- Mechanical hypersensitivity, a painful sensation exacerbated by a sharp, non-traumatic object, will be sought with a large calibre Von Frey filament.
- Static Allodynia, felt painful on contact, will be sought at Von Frey's filament.
- Dynamic Allodynia, felt painful when rubbed, will be sought with a wide brush (8 mm) over a distance of several centimetres.
Thermal neurosensory disorders will be sought for the skin with the Thermotest and at the level of the oral cavity with the application of standardised test tubes containing water at 4°C stored in the fridge or hot water at 63°C (the protocol consists of heating water at 4°C in the microwave for 30 seconds to obtain the temperature of 63°C); these examinations will allow the evaluation of thermal allodynia and hypoesthesia.
The examination will cover the entire face, the oral cavity, the cervical region and the area where the reconstruction flaps are taken. The pathological areas identified will be delimited on diagrams previously made with a coding according to the sensations collected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient treated for a oral cavity and oropharynx cancer | Experimental | Diagnostic Test: diagnostic tes for neuropathic painquestionnaire and tests to evaluate neuropathic pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient treated for an oral cavity and oropharynx tumor from at least one year and maximum five years.
- Women or men upper 18 years old)
- Patient with full consent, aware and signed
- Patient cover by the French social security system
Key exclusion criteria (5 listed)
- Patient with mental disorder, psychologic, with a defect of comprehension to agree fully the protocol
- Pregnant women or nursing
- Patients who can't comply with the protocol
- Participation refusal
- Inable full age patient or under judicial protection
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 |
|---|---|---|
| diagnostic tes for neuropathic painThermotest and hot water, cold water (for the oral cavity), Von frey filament and the brush | Diagnostic test | patient treated for a oral cavity and oropharynx cancer |
Primary outcome
hypoesthesia on surgical site using a brush and Von Frey Filament
Time frame: day 0
The measure is a binary measure (positive or negative)
anaesthesia on surgical site using a brush and Von Frey Filament
Time frame: day 0
The measure is a binary measure (positive or negative)
allodynia on surgical site
Time frame: day 0
The measure is a binary measure (positive or negative) by clinical examination
Evaluation of the characteristics of the pain by questionnaire DN4
Time frame: Day 0
One standard DN4 with four questions and ten pain characteristics which gave a score from zero to ten points. If DN4 equal or superior of four out of ten the patient seems possible to develop neuropathic pain.
hyperalgesia on surgical site using a brush and Von Frey Filament
Time frame: Day 0
The measure is a binary measure (positive or negative)
Evaluation of the characteristics of the pain by questionnaire Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Day 0
Twelve questions with a score from zero to ten, zero stands for no pain and ten maximal pain scale. A score is given for burning pain (score out of ten), constriction pain (score out of ten), paroxystic pain (score out of ten), evoked pain (score out of ten), paresthesia (score out of ten) and a total score (out of one hundred)
Evaluation of the characteristics of the pain by questionnaire Brief Pain Inventory
Time frame: Day 0
Fifteen questions compose the questionnaire, the first one is a binary answer yes or no, the second one is a schema to localize the pain, thirteen following questions are scaled with a score from zero to ten, zero stands for no pain and ten maximal pain scale
5 secondary outcomes
Questionnaire EORTC QLQC30 to assess Quality of life of cancer patients
Time frame: day 0
Questionnaire EORTC QLQ-H&N35 to assess Quality of life of head and neck cancer patient
Time frame: day 0
Quality of life evaluate by the Questionnaire EORTC QLQ-H&N35
Time frame: Day 0
Pain Catastrophizing Scale (PCS-CF) to assess the catastrophizing
Time frame: Day 0
Anxious and depression disorder screening using questionnaire Hospital Anxiety and Depression scale (HAD)
Time frame: day 0
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 2 Sep 2025.
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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.
Nathalie PHAM DANG principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic tes for neuropathic pain in people with Head Cancer and Neck Cancer, run by University Hospital, Clermont-Ferrand 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 5 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 2 Sep 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 Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypoesthesia on surgical site using a brush and Von Frey Filament (time frame: day 0). The study lists 7 primary outcomes in all. 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 2 Sep 2025.