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Recruiting Not applicable

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

NCT04673981 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-07-31
Last updated
2025-09-02

Condition(s) studied

Head CancerNeck CancerChronic Pain

Investigational drug(s) / intervention(s)

diagnostic tes for neuropathic pain

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • hypoesthesia on surgical site using a brush and Von Frey Filament — day 0
    The measure is a binary measure (positive or negative)
  • anaesthesia on surgical site using a brush and Von Frey Filament — day 0
    The measure is a binary measure (positive or negative)
  • allodynia on surgical site — day 0
    The measure is a binary measure (positive or negative) by clinical examination
  • Evaluation of the characteristics of the pain by questionnaire DN4 — 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.
  • hyperalgesia on surgical site using a brush and Von Frey Filament — Day 0
    The measure is a binary measure (positive or negative)
  • Evaluation of the characteristics of the pain by questionnaire Neuropathic Pain Symptom Inventory (NPSI) — 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)
  • Evaluation of the characteristics of the pain by questionnaire Brief Pain Inventory — 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

Trial sites (1)

FacilityCityRegionStatus
CHU de Clermont-Ferrand Clermont-Ferrand France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04673981 on ClinicalTrials.gov ↗ ← All trials in France