CH Valence
Valence, 26953, France
NCT Number: NCT03558789
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.
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Notify Me18 year and older
All sexes
Observational
Valence, 26953, France
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.
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.
2.2- Efficacy of a lactoferrin mouthwash to attenuate the sensation of MT. Omur-Ozbeck et al. showed that a lactoferrin mouthwash completely attenuated an artificially-created MT by an iron sulphate mouthwash. For the investigator's patients, in case of spontaneous presence of a MT or after having artificially created it by the iron sulphate mouthwash, a lactoferrin mouthwash will be proposed and its efficacy to attenuate the MT will be evaluated.
2.3- Psychophysical olfaction tests (European Test of olfactory Capacities ETOC from Thomas-Danguin T et al. Rhinology 2003;41:142-51) This test is constructed from odours contained in vials. It is made up of 16 series of 4 vials. In a series, only one of the four vials contains an odour. The patients must first find the vial which, among 4 contains the odour (test of detection) then in the vial chosen identify the odour (test of identification) among 4 alternatives proposed in the form of 4 verbal labels.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
mouthwash
Time frame: 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.
Time frame: 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
Additional chemical modifications of the saliva will be tested by salivary dosages: uric acid in µmol/ml
Time frame: 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
Additional chemical modifications of the saliva will be tested by salivary dosages: Mn2+ and Zn2+, in µmol/ml
Time frame: 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
Additional chemical modifications of the saliva will be tested by salivary dosages: peroxydase, catalase, superoxide dismutase (in IU/ml)
Time frame: 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
fungiform papillae density before, during and after treatment will be measured by tongue dermatoscopy. As metallic taste may vary according time, the measure will be repeated.
Time frame: 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 release of inhibition of the facial nerve on the glossopharyngeal nerve will be tested with taste and smell psychophysical tests (supraliminory intensity taste testing and European Tests of Olfactory Capabilities) and a metallic taste-specific questionnaire [IJpma et al. Metallic Taste in Cancer Patients Treated with Systemic Therapy: A Questionnaire-based Study. Cancer Nutr 2017]. As metallic taste may vary according time, the measure will be repeated.
Time frame: 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 presence of an intraoral electric current will be tested by impedancemetry. As metallic taste may vary according time, the measure will be repeated.
Time frame: 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
questionnaires (EORTC QLQ30 and HN35). As quality of life may vary according time, the measure will be repeated.
Time frame: 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
questionnaires (IJpma el al. Nutrition and cancer. 2017;69:140-5) and an analogic visual scale of dietary intakes (from 1 to 10, from Thibault R et al. Clin Nutr. 2009;28:134-40). As metallic taste may vary according time, the measure will be repeated.
Centre Hospitalier de Valence
Other
Metallic Taste Before, During and After Treatment of Head and Neck Cancer : Etiologies and Impact on Quality of Life
Acronym: TORCAD
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