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| Name | Class |
|---|---|
| Kantonsspital Aarau | OTHER |
| University of Bern | OTHER |
| University of Zurich | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head and neck cancer patients referred for radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive (semi-)objective and subjective taste, smell, and saliva analysis | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Taste impairment | Patient-reported taste impairment assessed by the MDASI-HN (MD Anderson Symptom Inventory Head and Neck module) questionnaire | 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Taste impairment | Patient-reported taste impairment assessed by the MDASI-HN (MD Anderson Symptom Inventory Head and Neck module) questionnaire | 24 months post-treatment |
| Taste impairment | Taste impairment diagnosed using taste strips |
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Inclusion Criteria:
Exclusion Criteria:
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Adult head and neck cancer patients referred for radiation therapy with curative intent, both definitive and post-operative
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonja Stieb, MD | Contact | +41 62 838 4179 | sonja.stieb@ksa.ch | |
| Oliver Riesterer, Prof., MD | Contact | +41 62 838 4249 | oliver.riesterer@ksa.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSB | Recruiting | Aarau | Canton of Aargau | 5001 | Switzerland |
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Saliva
|
| 12 and 24 months post-treatment |
| Universitätsspital Bern | Not yet recruiting | Bern | 3010 | Switzerland |
| Universitätsspital Zürich | Not yet recruiting | Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D004408 | Dysgeusia |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D013651 | Taste Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012903 | Smell |
| ID | Term |
|---|---|
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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