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

NCT04673981 | Recruiting

• 2 other identifiers: RBHP 2020 PHAM DANG2020-A00476-33
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Cancer; Neck Cancer; Chronic Pain

Keywords

Hypoesthesia; Allodynia; Orofacial; Neuropathic pain; cancer

Outcome Measures

Primary Outcomes (7)

• hypoesthesia on surgical site using a brush and Von Frey Filament

  The measure is a binary measure (positive or negative)

  day 0

• anaesthesia on surgical site using a brush and Von Frey Filament

  The measure is a binary measure (positive or negative)

  day 0

• allodynia on surgical site

  The measure is a binary measure (positive or negative) by clinical examination

  day 0

• 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

• hyperalgesia on surgical site using a brush and Von Frey Filament

  The measure is a binary measure (positive or negative)

  Day 0

• 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

• 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 Outcomes (5)

• Questionnaire EORTC QLQC30 to assess Quality of life of cancer patients

  day 0

• Questionnaire EORTC QLQ-H&N35 to assess Quality of life of head and neck cancer patient

  day 0

• Quality of life evaluate by the Questionnaire EORTC QLQ-H&N35

  Day 0

• Pain Catastrophizing Scale (PCS-CF) to assess the catastrophizing

  Day 0

• Anxious and depression disorder screening using questionnaire Hospital Anxiety and Depression scale (HAD)

  day 0

Study Arms (1)

patient treated for a oral cavity and oropharynx cancer

EXPERIMENTAL

questionnaire and tests to evaluate neuropathic pain

Diagnostic Test: diagnostic tes for neuropathic pain

Interventions

diagnostic tes for neuropathic pain DIAGNOSTIC_TEST

Thermotest and hot water, cold water (for the oral cavity), Von frey filament and the brush

patient treated for a oral cavity and oropharynx cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Chronic Pain; Hypesthesia; Hyperalgesia; Neuralgia; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Nathalie PHAM DANG

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: December 17, 2020
• Study Start: July 31, 2020
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

FR (1)