CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
Location status: Recruiting
Location contact
Laurent DEVOIZE
SUB_INVESTIGATOR
Nathalie PHAM DANG
CONTACT
Nathalie PHAM DANG
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04673981
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Clermont-Ferrand, 63000, France
Location status: Recruiting
Laurent DEVOIZE
SUB_INVESTIGATOR
Nathalie PHAM DANG
CONTACT
Nathalie PHAM DANG
PRINCIPAL_INVESTIGATOR
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
PART 2: Collecting Treatment Data
PART 3: Collection of data related to neurosensory disorders and pain
Mechanical neurosensory disorders will be tested with the Von frey filament and the brush.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Thermotest and hot water, cold water (for the oral cavity), Von frey filament and the brush
Time frame: day 0
The measure is a binary measure (positive or negative)
Time frame: day 0
The measure is a binary measure (positive or negative)
Time frame: day 0
The measure is a binary measure (positive or negative) by clinical examination
Time frame: Day 0
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
The measure is a binary measure (positive or negative)
Time frame: Day 0
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
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
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
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
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
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
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
Contact information is provided by the study sponsor or research team.
University Hospital, Clermont-Ferrand
Other
Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients
Acronym: OCAPA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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