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

NCT06444776 | Recruiting

• 1 other identifier: 2022-00706
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Radiotherapy; Taste impairment; Dysgeusia; Xerostomia; Saliva; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Taste impairment

  24 months post-treatment

• Taste impairment

  12 and 24 months post-treatment

Study Arms (1)

Head and neck cancer patients referred for radiation therapy

Diagnostic Test: Repetitive (semi-)objective and subjective taste, smell, and saliva analysis

Interventions

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

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.

Head and neck cancer patients referred for radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonja Stieb, MD: lead
• Kantonsspital Aarau: collaborator
• University of Bern: collaborator
• University of Zurich: collaborator

Study Sites (3)

Kantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSB

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

Universitätsspital Bern

Bern, 3010, Switzerland

NOT YET RECRUITING

Universitätsspital Zürich

Zurich, 8091, Switzerland

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva

MeSH Terms

Conditions

Head and Neck Neoplasms; Dysgeusia; Xerostomia

Interventions

Smell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Sonja Stieb, MD

CONTACT

+41 62 838 4179; sonja.stieb@ksa.ch

Oliver Riesterer, Prof., MD

CONTACT

+41 62 838 4249; oliver.riesterer@ksa.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med. Sonja Stieb, MD

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 6, 2024
• Study Start: December 19, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)