Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- hypoesthesia on surgical site using a brush and Von Frey Filament
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
hypoesthesia on surgical site using a brush and Von Frey Filament
时间窗: day 0
The measure is a binary measure (positive or negative)
anaesthesia on surgical site using a brush and Von Frey Filament
时间窗: day 0
The measure is a binary measure (positive or negative)
allodynia on surgical site
时间窗: day 0
The measure is a binary measure (positive or negative) by clinical examination
hyperalgesia on surgical site using a brush and Von Frey Filament
时间窗: 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)
时间窗: 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 DN4
时间窗: 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.
Evaluation of the characteristics of the pain by questionnaire Brief Pain Inventory
时间窗: 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
次要结局
- Quality of life evaluate by the Questionnaire EORTC QLQ-H&N35(Day 0)
- Questionnaire EORTC QLQ-H&N35 to assess Quality of life of head and neck cancer patient(day 0)
- Questionnaire EORTC QLQC30 to assess Quality of life of cancer patients(day 0)
- Anxious and depression disorder screening using questionnaire Hospital Anxiety and Depression scale (HAD)(day 0)
- Pain Catastrophizing Scale (PCS-CF) to assess the catastrophizing(Day 0)