Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients (OCAPA) (OCAPA)
Primary Purpose
Head Cancer, Neck Cancer, Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
diagnostic tes for neuropathic pain
Sponsored by
About this trial
This is an interventional diagnostic trial for Head Cancer focused on measuring Hypoesthesia, Allodynia, Orofacial, Neuropathic pain, cancer
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
Sites / Locations
- CHU de Clermont-FerrandRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patient treated for a oral cavity and oropharynx cancer
Arm Description
questionnaire and tests to evaluate neuropathic pain
Outcomes
Primary Outcome Measures
hypoesthesia on surgical site using a brush and Von Frey Filament
The measure is a binary measure (positive or negative)
anaesthesia on surgical site using a brush and Von Frey Filament
The measure is a binary measure (positive or negative)
allodynia on surgical site
The measure is a binary measure (positive or negative) by clinical examination
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.
hyperalgesia on surgical site using a brush and Von Frey Filament
The measure is a binary measure (positive or negative)
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)
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
Secondary Outcome Measures
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)
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).
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)
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.
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
Full Information
NCT ID
NCT04673981
First Posted
September 10, 2020
Last Updated
December 14, 2020
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT04673981
Brief Title
Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients (OCAPA)
Acronym
OCAPA
Official Title
Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2020 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Cancer, Neck Cancer, Chronic Pain
Keywords
Hypoesthesia, Allodynia, Orofacial, Neuropathic pain, cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient treated for a oral cavity and oropharynx cancer
Arm Type
Experimental
Arm Description
questionnaire and tests to evaluate neuropathic pain
Intervention Type
Diagnostic Test
Intervention Name(s)
diagnostic tes for neuropathic pain
Intervention Description
Thermotest and hot water, cold water (for the oral cavity), Von frey filament and the brush
Primary Outcome Measure Information:
Title
hypoesthesia on surgical site using a brush and Von Frey Filament
Description
The measure is a binary measure (positive or negative)
Time Frame
day 0
Title
anaesthesia on surgical site using a brush and Von Frey Filament
Description
The measure is a binary measure (positive or negative)
Time Frame
day 0
Title
allodynia on surgical site
Description
The measure is a binary measure (positive or negative) by clinical examination
Time Frame
day 0
Title
Evaluation of the characteristics of the pain by questionnaire DN4
Description
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.
Time Frame
Day 0
Title
hyperalgesia on surgical site using a brush and Von Frey Filament
Description
The measure is a binary measure (positive or negative)
Time Frame
Day 0
Title
Evaluation of the characteristics of the pain by questionnaire Neuropathic Pain Symptom Inventory (NPSI)
Description
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)
Time Frame
Day 0
Title
Evaluation of the characteristics of the pain by questionnaire Brief Pain Inventory
Description
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
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Questionnaire EORTC QLQC30 to assess Quality of life of cancer patients
Description
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)
Time Frame
day 0
Title
Questionnaire EORTC QLQ-H&N35 to assess Quality of life of head and neck cancer patient
Description
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).
Time Frame
day 0
Title
Quality of life evaluate by the Questionnaire EORTC QLQ-H&N35
Description
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)
Time Frame
Day 0
Title
Pain Catastrophizing Scale (PCS-CF) to assess the catastrophizing
Description
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.
Time Frame
Day 0
Title
Anxious and depression disorder screening using questionnaire Hospital Anxiety and Depression scale (HAD)
Description
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
Time Frame
day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie PHAM DANG
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie PHAM DANG
Phone
04 73 750 102
Email
nphamdang@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Nathalie PHAM DANG
First Name & Middle Initial & Last Name & Degree
Laurent DEVOIZE
12. IPD Sharing Statement
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Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients (OCAPA)
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