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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00476-33 | Other Identifier | ANSM |
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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.
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:
Verification of inclusion and non-inclusion criteria:
General patient history:
Tumor:
Search for risk factors for peripheral neuropathy
Check for symptoms of peripheral neuropathy.
PART 2: Collecting Treatment Data
Operating data:
On the way out:
PART 3: Collection of data related to neurosensory disorders and pain
Mechanical neurosensory disorders will be tested with the Von frey filament and the brush.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient treated for a oral cavity and oropharynx cancer | Experimental | questionnaire and tests to evaluate neuropathic pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diagnostic tes for neuropathic pain | Diagnostic Test | Thermotest and hot water, cold water (for the oral cavity), Von frey filament and the brush |
|
| Measure | Description | Time Frame |
|---|---|---|
| hypoesthesia on surgical site using a brush and Von Frey Filament | The measure is a binary measure (positive or negative) | day 0 |
| anaesthesia on surgical site using a brush and Von Frey Filament | The measure is a binary measure (positive or negative) | day 0 |
| allodynia on surgical site | The measure is a binary measure (positive or negative) by clinical examination | 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. | Day 0 |
| hyperalgesia on surgical site using a brush and Von Frey Filament | The measure is a binary measure (positive or negative) | 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) | Day 0 |
| Evaluation of the characteristics of the pain by questionnaire Brief Pain Inventory |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | day 0 |
| Questionnaire EORTC QLQ-H&N35 to assess Quality of life of head and neck cancer patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise LACLAUTRE | Contact | +33473754963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie PHAM DANG | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D059350 | Chronic Pain |
| D006987 | Hypesthesia |
| D006930 | Hyperalgesia |
| D009437 | Neuralgia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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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 |
| Day 0 |
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). |
| 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) | 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. | 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 | day 0 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |