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

Head and Neck Cancer Clinical Trial

— TASTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06444776
• Other study ID #: 2022-00706
• Status: Recruiting
• Start date: December 19, 2022
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Kantonsspital Aarau
• Contact: Sonja Stieb, MD
• Phone: +41 62 838 4179
• Email: sonja.stieb[@]ksa.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2027
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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

Country	Name	City	State
Switzerland	Kantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSB	Aarau	Aargau
Switzerland	Universitätsspital Bern	Bern
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (4)

Lead Sponsor	Collaborator
Sonja Stieb, MD	Kantonsspital Aarau, University of Bern, University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

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