Metallic TasteTORCADNCT03558789
Metallic Taste Before, During and After Treatment of Head and Neck Cancer
An observational study of Metallic Taste, run by Centre Hospitalier de Valence at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metallic Taste
- What is being tested?
- bovine lactoferrin
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2018to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patients with head and neck cancer before any treatment will be recruited. Repartition between the two groups will be performed a posteriori after onset or not of the metallic taste perception.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metallic Taste Before, During and After Treatment of Head and Neck Cancer : Etiologies and Impact on Quality of Life
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.
Read the detailed 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.
- 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.
- 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.
- 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.
- Evaluation of food intake by patients weighing, an analogic visual scale and of food pleasantness by MT specific questionnaire.
- Characterization of quality of life through general EORTC QLQ30 and HNC-specific EORTC HNC35 quality of life questionnaires.
- Conditions
- Metallic Taste
- Being tested
- bovine lactoferrin
- Medical subject headings
- Taste Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bovine lactoferrinBiological
mouthwash
| Study group | Role | What they receive |
|---|---|---|
| MT | patients complaining about metallic taste before, during or after treatment of head and neck cancer. Receives: Biological: bovine lactoferrin | |
| No-MT | patients not complaining about metallic taste before, during or after treatment of head and neck cancer. Receives: Biological: bovine lactoferrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (8)
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
Measured: 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
Additional chemical modifications of the saliva will be tested by salivary dosages: Mn2+ and Zn2+, in µmol/ml
Measured: 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
Additional chemical modifications of the saliva will be tested by salivary dosages: peroxydase, catalase, superoxide dismutase (in IU/ml)
Measured: 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 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.
Measured: 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
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.
Measured: 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
the presence of an intraoral electric current will be tested by impedancemetry. As metallic taste may vary according time, the measure will be repeated.
Measured: 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
questionnaires (EORTC QLQ30 and HN35). As quality of life may vary according time, the measure will be repeated.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start26 Apr 2018
- Primary completion1 Dec 2022
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metallic TasteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valence
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Feron, PhD, Study director, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558789
- Sponsor's protocol ID
- RIPH-CHV-01
- Acronym
- TORCAD
- Status last verified
- Dec 2023
- First submitted
- 26 Apr 2018
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buiret G, Brignot H, Septier C, Thomas-Danguin T, Feron G. The nutritional impact of metallic taste in head and neck cancer patients: explorations and clinical implications. Support Care Cancer. 2024 Sep 11;32(10):651. doi: 10.1007/s00520-024-08854-z.
PubMed 39256281
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metallic Taste Before, During and After Treatment of Head and Neck Cancer : Etiologies and Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT03558789
- Acronym / sponsor ID
- TORCAD / RIPH-CHV-01
- Conditions
- Metallic Taste
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier de ValenceUniversity, hospital or other
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
- 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.
- 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.
- 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.
- Evaluation of food intake by patients weighing, an analogic visual scale and of food pleasantness by MT specific questionnaire.
- Characterization of quality of life through general EORTC QLQ30 and HNC-specific EORTC HNC35 quality of life questionnaires.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT | – | Biological: bovine lactoferrinpatients complaining about metallic taste before, during or after treatment of head and neck cancer. |
| No-MT | – | Biological: bovine lactoferrinpatients not complaining about metallic taste before, during or after treatment of head and neck cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients with head and neck cancer before any treatment will be recruited. Repartition between the two groups will be performed a posteriori after onset or not of the metallic taste perception.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bovine lactoferrinmouthwash | Biological | MT, No-MT |
Primary outcome
Change from Baseline salivary malondialdehyde level within one year after treatment completion
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.
8 secondary outcomes
Change from Baseline métabolites levels modifications of the saliva within one year after treatment completion
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
Change from Baseline ions levels modifications of the saliva within one year after treatment completion
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
Change from Baseline enzymes levels modifications of the saliva within one year after treatment completion
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
Change from Baseline fungiform papillae density of the tonguewithin one year after treatment completion
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
release of inhibition of the facial nerve on the glossopharyngeal nerve
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
change from Baseline intraoral electric current within one year after treatment completion
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
Change frome Baseline quality of life within one year after treatment completion
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
Change frome Baseline food pleasantness and acceptability within one year after treatment completion
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 39256281Buiret G, Brignot H, Septier C, Thomas-Danguin T, Feron G. The nutritional impact of metallic taste in head and neck cancer patients: explorations and clinical implications. Support Care Cancer. 2024 Sep 11;32(10):651. doi: 10.1007/s00520-024-08854-z.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Feron, PhD study director
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metallic Taste, run by Centre Hospitalier de Valence at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline salivary malondialdehyde level within one year after treatment completion (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03558789, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.