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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Diagnostic test: Repetitive (semi-)objective and subjective taste, smell, and saliva analysis

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Sonja Stieb, MD; Phone Number: +41 62 838 4179; Email: sonja.stieb@ksa.ch
• Study Contact Backup: Name: Oliver Riesterer, Prof., MD; Phone Number: +41 62 838 4249; Email: oliver.riesterer@ksa.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Not yet recruiting
    • Universitätsspital Bern
  • Zürich, Switzerland, 8091
    • Not yet recruiting
    • UniversitätsSpital Zürich
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Recruiting
      • Kantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSB
      • Contact: Sonja Stieb, MD; Phone Number: +41 62 838 4179; Email: sonja.stieb@ksa.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult head and neck cancer patients referred for radiation therapy with curative intent, both definitive and post-operative

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Head and neck cancer patients referred for radiation therapy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Taste impairment	Patient-reported taste impairment assessed by the MDASI-HN (MD Anderson Symptom Inventory Head and Neck module) questionnaire	12 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Taste impairment	Patient-reported taste impairment assessed by the MDASI-HN (MD Anderson Symptom Inventory Head and Neck module) questionnaire	24 months post-treatment
Taste impairment	Taste impairment diagnosed using taste strips	12 and 24 months post-treatment

Collaborators and Investigators

• Sponsor: Sonja Stieb, MD
• Collaborators: University of Zurich; Kantonsspital Aarau; University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Quality of life; Radiotherapy; Xerostomia; Saliva; Dysgeusia; Taste impairment
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 2022-00706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No