Metallic Taste Before, During and After Treatment of Head and Neck Cancer

Metallic Taste Clinical Trial

— TORCAD  

Official title:

Metallic Taste Before, During and After Treatment of Head and Neck Cancer : Etiologies and Impact on Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558789
• Other study ID #: 00001
• Status: Completed
• Start date: April 26, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: Centre Hospitalier de Valence
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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. 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. 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. 3. Impedancemetry Measurements of the spontaneous presence of a current in the oral cavity and the resistivity of the oral mucosa will be carried out by application of an electrode on the back of the tongue. This procedure is painless. 4. Evaluation of food intake by patients weighing, an analogic visual scale and of food pleasantness by MT specific questionnaire. 5. Characterization of quality of life through general EORTC QLQ30 and HNC-specific EORTC HNC35 quality of life questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Metallic Taste
• Taste Disorders

Intervention

Biological:
• bovine lactoferrin
mouthwash

Locations

Country	Name	City	State
France	CH Valence	Valence

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Valence

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline salivary malondialdehyde level within one year after treatment completion	The lipoperoxidation will be measured with salivary dosage of malondialdehyde (µmol/L). As metallic taste may vary according time, the measure will be repeated.	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
Secondary	Change from Baseline métabolites levels modifications of the saliva within one year after treatment completion	Additional chemical modifications of the saliva will be tested by salivary dosages: uric acid in µmol/ml	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
Secondary	Change from Baseline ions levels modifications of the saliva within one year after treatment completion	Additional chemical modifications of the saliva will be tested by salivary dosages: Mn2+ and Zn2+, in µmol/ml	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
Secondary	Change from Baseline enzymes levels modifications of the saliva within one year after treatment completion	Additional chemical modifications of the saliva will be tested by salivary dosages: peroxydase, catalase, superoxide dismutase (in IU/ml)	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
Secondary	Change from Baseline fungiform papillae density of the tonguewithin one year after treatment completion	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.	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
Secondary	release of inhibition of the facial nerve on the glossopharyngeal nerve	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.	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
Secondary	change from Baseline intraoral electric current within one year after treatment completion	the presence of an intraoral electric current will be tested by impedancemetry. As metallic taste may vary according time, the measure will be repeated.	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
Secondary	Change frome Baseline quality of life within one year after treatment completion	questionnaires (EORTC QLQ30 and HN35). As quality of life may vary according time, the measure will be repeated.	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
Secondary	Change frome Baseline food pleasantness and acceptability within one year after treatment completion	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.	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