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Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04673981
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Clermont-Ferrand
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nathalie PHAM DANG
Principal Investigator Affiliation University Hospital, Clermont-Ferrand
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Head Cancer, Neck Cancer, Chronic Pain
Additional Details

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.

Arms & Interventions

Arms

Experimental: patient treated for a oral cavity and oropharynx cancer

questionnaire and tests to evaluate neuropathic pain

Interventions

Diagnostic Test: - diagnostic tes for neuropathic pain

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU de Clermont-Ferrand, Clermont-Ferrand, France

Status

Recruiting

Address

CHU de Clermont-Ferrand

Clermont-Ferrand, , 63000

Site Contact

Nathalie PHAM DANG

[email protected]

04 73 750 102

Nearest Location

Site Contact

Nathalie PHAM DANG

[email protected]

04 73 750 102


Resources

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with a healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with site contacts or other relevant parties. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage trial participants to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

The THANC Foundation is a 501(c)(3) charitable organization.

Federal Tax ID 80-0062118.

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