Clinical trial NCT04673981: Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients (OCAPA)
Official title: Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head Cancer
Neck Cancer
Chronic Pain
Keywords: Hypoesthesia
Allodynia
Orofacial
Neuropathic pain
cancer
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: hypoesthesia on surgical site using a brush and Von Frey Filament
timeFrame: day 0
measure: anaesthesia on surgical site using a brush and Von Frey Filament
timeFrame: day 0
measure: allodynia on surgical site
timeFrame: day 0
measure: Evaluation of the characteristics of the pain by questionnaire DN4
timeFrame: Day 0
measure: hyperalgesia on surgical site using a brush and Von Frey Filament
timeFrame: Day 0
measure: Evaluation of the characteristics of the pain by questionnaire Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Day 0
measure: Evaluation of the characteristics of the pain by questionnaire Brief Pain Inventory
timeFrame: Day 0
Secondary outcomes:
measure: Questionnaire EORTC QLQC30 to assess Quality of life of cancer patients
timeFrame: day 0
measure: Questionnaire EORTC QLQ-H&N35 to assess Quality of life of head and neck cancer patient
timeFrame: day 0
measure: Quality of life evaluate by the Questionnaire EORTC QLQ-H&N35
timeFrame: Day 0
measure: Pain Catastrophizing Scale (PCS-CF) to assess the catastrophizing
timeFrame: Day 0
measure: Anxious and depression disorder screening using questionnaire Hospital Anxiety and Depression scale (HAD)
timeFrame: day 0
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Nathalie PHAM DANG
role: PRINCIPAL_INVESTIGATOR
References: