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Clinical Trials/NCT06444776
NCT06444776
Recruiting
Not Applicable

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

Sonja Stieb, MD3 sites in 1 country150 target enrollmentDecember 19, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
Sonja Stieb, MD
Enrollment
150
Locations
3
Primary Endpoint
Taste impairment
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 19, 2022
End Date
December 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Sonja Stieb, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Sonja Stieb, MD

Dr. med. Sonja Stieb, MD

Kantonsspital Aarau

Eligibility Criteria

Inclusion Criteria

  • Head and neck cancer patients
  • Referred for radiation therapy with curative intent, both definitive and post-operative
  • 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

Outcomes

Primary Outcomes

Taste impairment

Time Frame: 12 months post-treatment

Patient-reported taste impairment assessed by the MDASI-HN (MD Anderson Symptom Inventory Head and Neck module) questionnaire

Secondary Outcomes

  • Taste impairment(12 and 24 months post-treatment)

Study Sites (3)

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