Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients (OCAPA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
diagnostic tes for neuropathic pain
Diagnostic testThermotest and hot water, cold water (for the oral cavity), Von frey filament and the brush
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: patient treated for a oral cavity and oropharynx cancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
hypoesthesia on surgical site using a brush and Von Frey Filament
The measure is a binary measure (positive or negative)
Time frame
day 02
anaesthesia on surgical site using a brush and Von Frey Filament
The measure is a binary measure (positive or negative)
Time frame
day 03
allodynia on surgical site
The measure is a binary measure (positive or negative) by clinical examination
Time frame
day 04
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.
Time frame
Day 0Secondary outcomes
1
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)
Time frame
day 02
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).
Time frame
day 03
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)
Time frame
Day 04
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.
Time frame
Day 0Sponsors and contacts
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Source ClinicalTrials.gov