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

Chronic Pain Clinical Trial

— OCAPA  

Official title:

Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04673981
• Other study ID #: RBHP 2020 PHAM DANG
• Secondary ID: 2020-A00476-33
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2020
• Est. completion date: July 2025

Study information

• Verified date: September 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

The objective of the study is to map and qualitatively evaluate neurosensory disorders in patients treated for cancers of the oral cavity and oropharynx.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Head and Neck Neoplasms
• Head Cancer
• Neck Cancer
• Oropharyngeal Neoplasms

Intervention

Diagnostic Test:
• diagnostic tes for neuropathic pain
Thermotest and hot water, cold water (for the oral cavity), Von frey filament and the brush

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypoesthesia on surgical site using a brush and Von Frey Filament	The measure is a binary measure (positive or negative)	day 0
Primary	anaesthesia on surgical site using a brush and Von Frey Filament	The measure is a binary measure (positive or negative)	day 0
Primary	allodynia on surgical site	The measure is a binary measure (positive or negative) by clinical examination	day 0
Primary	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
Primary	hyperalgesia on surgical site using a brush and Von Frey Filament	The measure is a binary measure (positive or negative)	Day 0
Primary	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
Primary	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	Day 0
Secondary	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
Secondary	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).	day 0
Secondary	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
Secondary	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
Secondary	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