Metallic Taste Before, During and After Treatment of Head and Neck Cancer : Etiologies and Impact on Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from Baseline salivary malondialdehyde level within one year after treatment completion
研究概览
简要总结
Metallic taste in head and neck cancer is widely under-estimated in the literature. Its causes are multiple and poorly defined. Though it has a strong impact on the nutritional status.
The main objective of the TORCAD project is to test the hypothesis that intraoral lipoperoxidation is associated to metallic taste onset before, during and after treatment of head and neck cancer (HNC).
The secondary goals are to evaluate the involvement of others physiopathological factors in metallic taste: (i) additional chemical modification in the saliva; (ii) release of inhibition of the facial nerve on the glossopharyngeal nerve; presence of an intraoral electric current; food pleasantness and acceptability; quality of life.
详细描述
The objectives of this study are to perform tests and questionnaires. All samples will be non-invasive.
Evaluation of metallic taste (MT) occurrence with a specific questionnaire. In a single patient, MT occurrence may vary according to the time of the study.
- Oral media modifications 1.1- Salivary functions: basal and stimulated salivary flow will be determined. Immediately after collection, both salivary samples will be stored at -80°C. Twice a year frosted samples will be delivered to the Centre des Sciences du Goût et de l'Alimentation in Dijon, France) by a special transporter. Biochemical analyses of saliva will consist of analyses of candidate markers: malondialdehyde, metabolites (uric acid), ions (Mn2+ and Zn2+), enzymatic activities and key proteins involved in the salivary peroxidation (catalase, superoxide dismutase). All the technics are already validated.
1.2- Quantification of fungiform papillae in dermatoscopy. The objective of the dermatoscope is placed on the tongue and a snapshot of a predefined surface area will be recorded on both sides of the tongue. The density will be estimated according to an automatic method from the snapshots.
1.3- Trapping of nasal scents To assess the presence of volatile odorous compounds induced by the oral lipoperoxidation, the nasal scents of the patients will be harvested by a Tenax® trap positioned at the exit of nostril. The operation will be performed without any stimulus, after an iron sulphate mouthwash (artificially inducing MT) and after treatment with lactoferrin mouthwash (chelating agent). The traps will be hermetically closed and sent to the Centre des Sciences du gout et de l'Alimentation in Dijon for analysis by gas chromatography/mass spectrometry. These tests will be performed after psychophysical tests not to distort their results. 2. Psychophysical tests. 2.1- Psychophysical tests of taste intensity will be carried out with two aqueous solutions (one neutral, the other sapid) of each taste (salty, sweet, sour, bitter and umami) and iron sulphate. The solutions will moisten 0.5 cm-diameter filter paper discs that will be deposited on the tongue. For each taste, patients will have to indicate the disc with the strongest and least strong taste. Four locations on the tongue will be tested: one for the territory of the facial nerve (anterior tongue), one for the glossopharyngeal nerve (tongue base), repeated on both sides.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Any head and neck cancer
- •Before any treatment and treatment (surgery, chemotherapy, radiation therapy)
- •Before the appearance of the metallic taste symptom
- •Age ≥ 18 years
- •Estimated life expectancy ≥ 6 months.
- •Affiliation to a Social security system
- •Patient who has given written consent signed before any specific procedure of the protocol
排除标准
- •History of cancer (head and neck or other) that could be a confounding factor (dysgeusia, dysosmia, salivary composition disorder)
- •Pregnant woman (frequent dysgeusia and dysosmia)
- •Total laryngectomy (treatment-induced hyposmia)
- •Early cancer recurrence (< 6 months after the end of the last treatment) because the taste, smell, and/or composition of the saliva can be altered by the cancer itself
- •Persons deprived of liberty, under guardianship or under curatorship or unable to submit to the medical follow-up of the test for geographical, social or psychic reasons
研究组 & 干预措施
MT
patients complaining about metallic taste before, during or after treatment of head and neck cancer.
干预措施: bovine lactoferrin (Biological)
No-MT
patients not complaining about metallic taste before, during or after treatment of head and neck cancer.
干预措施: bovine lactoferrin (Biological)
结局指标
主要结局
Change from Baseline salivary malondialdehyde level within one year after treatment completion
时间窗: Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0
The lipoperoxidation will be measured with salivary dosage of malondialdehyde (µmol/L). As metallic taste may vary according time, the measure will be repeated.
次要结局
- Change from Baseline fungiform papillae density of the tonguewithin one year after treatment completion(Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0)
- Change frome Baseline food pleasantness and acceptability within one year after treatment completion(Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0)
- Change from Baseline métabolites levels modifications of the saliva within one year after treatment completion(Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0)
- Change from Baseline ions levels modifications of the saliva within one year after treatment completion(Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0)
- Change from Baseline enzymes levels modifications of the saliva within one year after treatment completion(Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0)
- Change frome Baseline quality of life within one year after treatment completion(Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0)
- release of inhibition of the facial nerve on the glossopharyngeal nerve(Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0)
- change from Baseline intraoral electric current within one year after treatment completion(Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0)