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NCT06444776Recruiting

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

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.

Inclusion criteria

• 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

Exclusion criteria

• 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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
—
Study type
Observational
Countries
Switzerland
Sponsor
Sonja Stieb, MD(Other)
Protocol no.
2022-00706
Conditions
Head and Neck Cancer
Interventions
Diagnostic test

Treatments studied

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

Collaborators

Kantonsspital Aarau, University of Bern, University of Zurich

Locations · 1

  • Aarau, SwitzerlandKantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSBRecruiting at this site

In total, worldwide, 1 of the 3 sites listed in the registry is recruiting; the other 2 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: June 6, 2024).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.