Head and Neck CancerTASTENCT06444776
Therapy-Associated Saliva and Taste Change Evaluation (TASTE) in Head & Neck Cancer Patients Undergoing Radiotherapy
An observational study of Head and Neck Cancer, run by Sonja Stieb, MD at 3 sites in Switzerland.
Trial summary
One of the main side effects of radiation therapy to the head and neck region is altered taste sensation. This causes significant morbidity and has profound effects on the quality of life (QoL) of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Repetitive (semi-)objective and subjective taste, smell, and saliva analysis
- How many people
- 150 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 19 Dec 2022to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult head and neck cancer patients referred for radiation therapy with curative intent, both definitive and post-operative
Who may be able to join
- Head and neck cancer patients
- Referred for radiation therapy with curative intent, both definitive and post-operative
- Age ≥18
- Karnofsky performance index of at least 50%
- Anticipated mean radiation dose to the taste bud bearing tongue mucosa or at least one of the major salivary glands (parotid, submandibular, and/or sublingual gland) of at the minimum 5 Gy
Who cannot join
- Pregnancy
- Pre-existing subjective complete loss of taste before start of radiation therapy
- Planning CT and radiation therapy with oral stent or spacer
- Partial or total glossectomy which impairs taste assessments of at least one side of the tongue or impairs contouring of the taste bud bearing tongue mucosa on the planning CT
- Inability to follow instructions related to study procedures or inability to fill in the questionnaires
- Inability to provide informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites, 3 recruiting
- Recruiting
Kantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSB
Aarau, Canton of Aargau, 5001
Sonja Stieb, MD, +41 62 838 4179, sonja.stieb@ksa.ch
- Not yet recruiting
Universitätsspital Bern
Bern, 3010
- Not yet recruiting
Universitätsspital Zürich
Zurich, 8091
About this study
Official title: Therapy-Associated Saliva and Taste Change Evaluation (TASTE) in Head & Neck Cancer
One of the main side effects of radiation therapy to the head and neck region is altered taste sensation. This causes significant morbidity and has profound effects on the quality of life (QoL) of patients. While radiation-associated toxicities like xerostomia and dysphagia are part of large investigations, data on taste impairment is sparse.
The TASTE study sets out to further our understanding of this common side effect with the goal to prevent radiation-associated taste impairment in future patients.
In this prospective, observational multicenter study 150 head and neck cancer patients undergoing radiation therapy will be recruited. Participants will undergo repetitive (semi-) objective and subjective assessment of their taste, smell and salivary function at specific time points before, during and after radiotherapy. Primary endpoint will be patient-reported taste impairment 12 months post radiation therapy using a standardized quality of life questionnaire (MDASI-HN). Secondary endpoints will include taste impairment measured using taste strips at 12 months and 2 years post radiation therapy. Differences between subgroups (radiation side, chemotherapy, etc.) and changes over time will be assessed while adjusting for confounding factors (e.g. age, sex, smoking history). Based on the aquired data, a normal tissue complication probability model for late radiation-associated taste impairment will be develeoped.
- Conditions
- Head and Neck Cancer
- Being tested
- Repetitive (semi-)objective and subjective taste, smell, and saliva analysis
- Keywords
- Head and Neck Cancer, Radiotherapy, Taste impairment, Dysgeusia, Xerostomia, Saliva, Quality of life
- Medical subject headings
- Head and Neck Neoplasms, Dysgeusia, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive (semi-)objective and subjective taste, smell, and saliva analysisDiagnostic test
Study participants will undergo repetitive assessments of their taste, smell and saliva, using quality of life questionnaires, taste strips, sniffin sticks, and analysis of salivary function and composition.
Assessments will be done before treatment, in the 4th week (+/- 1 week) and last week of radiation therapy (+/- 1 week), and at 6 months (+/- 1 months) and 1 and 2 years post-therapy (+/- 3 months).
At the minimum, participants are expected to complete the assessments at baseline and 1 year after the end of radiation therapy. Assessments at all other time points are strongly encouraged but will be optional.
| Study group | Role | What they receive |
|---|---|---|
| Head and neck cancer patients referred for radiation therapy | Not described Receives: Diagnostic Test: Repetitive (semi-)objective and subjective taste, smell, and saliva analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste impairment
Patient-reported taste impairment assessed by the MDASI-HN (MD Anderson Symptom Inventory Head and Neck module) questionnaire
Measured: 12 months post-treatment
Secondary outcomes (2)
Taste impairment
Patient-reported taste impairment assessed by the MDASI-HN (MD Anderson Symptom Inventory Head and Neck module) questionnaire
Measured: 24 months post-treatment
Taste impairment
Taste impairment diagnosed using taste strips
Measured: 12 and 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start19 Dec 2022
- Primary completionOct 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonja Stieb, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Aarau, University of Bern, University of Zurich
- Responsible party
- Sponsor-investigator, Sonja Stieb, MD, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444776
- Sponsor's protocol ID
- 2022-00706
- Acronym
- TASTE
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy-Associated Saliva and Taste Change Evaluation (TASTE) in Head & Neck Cancer
- ClinicalTrials.gov ID
- NCT06444776
- Acronym / sponsor ID
- TASTE / 2022-00706
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Radiotherapy, Taste impairment, Dysgeusia, Xerostomia, Saliva, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sonja Stieb, MDUniversity, hospital or other
- Collaborators
- Kantonsspital Aarau, University of Bern, University of Zurich
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Jun 2024 (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.
One of the main side effects of radiation therapy to the head and neck region is altered taste sensation. This causes significant morbidity and has profound effects on the quality of life (QoL) of patients. While radiation-associated toxicities like xerostomia and dysphagia are part of large investigations, data on taste impairment is sparse.
The TASTE study sets out to further our understanding of this common side effect with the goal to prevent radiation-associated taste impairment in future patients.
In this prospective, observational multicenter study 150 head and neck cancer patients undergoing radiation therapy will be recruited. Participants will undergo repetitive (semi-) objective and subjective assessment of their taste, smell and salivary function at specific time points before, during and after radiotherapy. Primary endpoint will be patient-reported taste impairment 12 months post radiation therapy using a standardized quality of life questionnaire (MDASI-HN). Secondary endpoints will include taste impairment measured using taste strips at 12 months and 2 years post radiation therapy. Differences between subgroups (radiation side, chemotherapy, etc.) and changes over time will be assessed while adjusting for confounding factors (e.g. age, sex, smoking history). Based on the aquired data, a normal tissue complication probability model for late radiation-associated taste impairment will be develeoped.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and neck cancer patients referred for radiation therapy | – | Diagnostic Test: Repetitive (semi-)objective and subjective taste, smell, and saliva analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult head and neck cancer patients referred for radiation therapy with curative intent, both definitive and post-operative
Key inclusion criteria (5 listed)
- Head and neck cancer patients
- Referred for radiation therapy with curative intent, both definitive and post-operative
- Age ≥18
- Karnofsky performance index of at least 50%
- Anticipated mean radiation dose to the taste bud bearing tongue mucosa or at least one of the major salivary glands (parotid, submandibular, and/or sublingual gland) of at the minimum 5 Gy
Key exclusion criteria (6 listed)
- Pregnancy
- Pre-existing subjective complete loss of taste before start of radiation therapy
- Planning CT and radiation therapy with oral stent or spacer
- Partial or total glossectomy which impairs taste assessments of at least one side of the tongue or impairs contouring of the taste bud bearing tongue mucosa on the planning CT
- Inability to follow instructions related to study procedures or inability to fill in the questionnaires
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 |
|---|---|---|
| Repetitive (semi-)objective and subjective taste, smell, and saliva analysisStudy participants will undergo repetitive assessments of their taste, smell and saliva, using quality of life questionnaires, taste strips, sniffin sticks, and analysis of salivary function and composition. Assessments will be done before treatment, in the 4th week (+/- 1 week) and last week of radiation therapy (+/- 1 week), and at 6 months (+/- 1 months) and 1 and 2 years post-therapy (+/- 3 months). At the minimum, participants are expected to complete the assessments at baseline and 1 year after the end of radiation therapy. Assessments at all other time points are strongly encouraged but will be optional. | Diagnostic test | Head and neck cancer patients referred for radiation therapy |
Primary outcome
Taste impairment
Time frame: 12 months post-treatment
Patient-reported taste impairment assessed by the MDASI-HN (MD Anderson Symptom Inventory Head and Neck module) questionnaire
2 secondary outcomes
Taste impairment
Time frame: 24 months post-treatment
Taste impairment
Time frame: 12 and 24 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Sonja Stieb, MD at 3 sites in Switzerland.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonja Stieb, MD (+41 62 838 4179, sonja.stieb@ksa.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste impairment (time frame: 12 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2024.