Actively Recruiting
Therapy-Associated Saliva and Taste Change Evaluation (TASTE) in Head & Neck Cancer Patients Undergoing Radiotherapy
Led by Sonja Stieb, MD · Updated on 2024-06-06
150
Participants Needed
3
Research Sites
258 weeks
Total Duration
On this page
Sponsors
S
Sonja Stieb, MD
Lead Sponsor
K
Kantonsspital Aarau
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Therapy-Associated Saliva and Taste Change Evaluation (TASTE) in Head & Neck Cancer Patients Undergoing Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with head and neck cancer
- Referred for radiation therapy with curative intent, either definitive or post-operative
- At least 18 years old
- Karnofsky performance index of at least 50%
- Expected radiation dose to taste bud tongue mucosa or major salivary glands of at least 5 Gy
You will not qualify if you...
- Pregnant
- Complete loss of taste before starting radiation therapy
- Radiation therapy using oral stent or spacer
- Partial or total glossectomy impairing taste assessment or tongue mucosa contouring
- Unable to follow study instructions or complete questionnaires
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Kantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSB
Aarau, Canton of Aargau, Switzerland, 5001
Actively Recruiting
2
Universitätsspital Bern
Bern, Switzerland, 3010
Not Yet Recruiting
3
Universitätsspital Zürich
Zurich, Switzerland, 8091
Not Yet Recruiting
Research Team
S
Sonja Stieb, MD
CONTACT
O
Oliver Riesterer, Prof., MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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