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

NCT ID: NCT04673981

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2028-07-31

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.

Conditions

Head Cancer; Neck Cancer; Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patient treated for a oral cavity and oropharynx cancer

questionnaire and tests to evaluate neuropathic pain

Group Type: EXPERIMENTAL

diagnostic tes for neuropathic pain

Intervention Type: DIAGNOSTIC_TEST

Thermotest and hot water, cold water (for the oral cavity), Von frey filament and the brush

Interventions

diagnostic tes for neuropathic pain

Thermotest and hot water, cold water (for the oral cavity), Von frey filament and the brush

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie PHAM DANG

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise LACLAUTRE

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Facility Contacts

Nathalie PHAM DANG

Role: primary

nphamdang@chu-clermontferrand.fr

04 73 750 102

Other Identifiers

2020-A00476-33

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2020 PHAM DANG

Identifier Type: -

Identifier Source: org_study_id