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RECRUITING
NCT06444776

Therapy-Associated Saliva and Taste Change Evaluation (TASTE) in Head & Neck Cancer Patients Undergoing Radiotherapy

Sponsor: Sonja Stieb, MD

View on ClinicalTrials.gov

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. 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.

Official title: Therapy-Associated Saliva and Taste Change Evaluation (TASTE) in Head & Neck Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2022-12-19

Completion Date

2027-12

Last Updated

2024-06-06

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Repetitive (semi-)objective and subjective taste, smell, and saliva analysis

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.

Locations (3)

Kantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSB

Aarau, Canton of Aargau, Switzerland

Universitätsspital Bern

Bern, Switzerland

Universitätsspital Zürich

Zurich, Switzerland