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NCT Number: NCT06444776

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

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.

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Key information

Conditions

Head and Neck Cancer Dysgeusia Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Salivary Gland Diseases Sensation Disorders Signs and Symptoms Stomatognathic Diseases Taste Disorders Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSB, Aarau, Canton of Aargau, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Taste impairment

    Time frame: 24 months post-treatment

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

  2. Taste impairment

    Time frame: 12 and 24 months post-treatment

    Taste impairment diagnosed using taste strips

Study contacts

Contact information is provided by the study sponsor or research team.

Oliver Riesterer, Prof., MD

CONTACT

[email protected]

+41 62 838 4249

Sonja Stieb, MD

CONTACT

[email protected]

+41 62 838 4179

Sponsors and collaborators

Lead sponsor

Sonja Stieb, MD

Other

Collaborators

  • Kantonsspital Aarau
  • University of Bern
  • University of Zurich

Registry information

Official study title

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

Acronym: TASTE

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Jun 6, 2024
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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