Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients (OCAPA)

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Head Cancer; Chronic Pain; Neck Cancer

Treatments: Diagnostic Test: diagnostic tes for neuropathic pain

Study type: Interventional

Funder types: Other

Identifiers

NCT04673981

2020-A00476-33 (Other Identifier)

RBHP 2020 PHAM DANG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

patient treated for a oral cavity and oropharynx cancer

Experimental group

Description:

questionnaire and tests to evaluate neuropathic pain

Treatment:

Diagnostic Test: diagnostic tes for neuropathic pain