RecruitingNCT06444776

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

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


Sponsor

Sonja Stieb, MD

Enrollment

150 participants

Start Date

Dec 19, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tracks changes in saliva production and sense of taste in head and neck cancer patients receiving radiation therapy. Understanding how and when these changes happen may help doctors better manage these side effects during and after treatment. **You may be eligible if...** - You have head and neck cancer and are receiving radiation therapy with the intention to cure - You are 18 or older and in reasonable health (Karnofsky score at least 50%) - Your radiation plan is expected to deliver meaningful dose to your taste buds or salivary glands **You may NOT be eligible if...** - You are pregnant - You already have a complete loss of taste before radiation starts - You are having radiation with an oral stent or spacer - You have had part or all of your tongue removed in a way that affects taste assessment - You are unable to fill out questionnaires or follow study instructions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTRepetitive (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

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NCT06444776


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