Actively Recruiting

Age: 18Years +
All Genders
NCT06444776

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

Led by Sonja Stieb, MD · Updated on 2024-06-06

150

Participants Needed

3

Research Sites

258 weeks

Total Duration

On this page

Sponsors

S

Sonja Stieb, MD

Lead Sponsor

K

Kantonsspital Aarau

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with head and neck cancer
  • Referred for radiation therapy with curative intent, either definitive or post-operative
  • At least 18 years old
  • Karnofsky performance index of at least 50%
  • Expected radiation dose to taste bud tongue mucosa or major salivary glands of at least 5 Gy
Not Eligible

You will not qualify if you...

  • Pregnant
  • Complete loss of taste before starting radiation therapy
  • Radiation therapy using oral stent or spacer
  • Partial or total glossectomy impairing taste assessment or tongue mucosa contouring
  • Unable to follow study instructions or complete questionnaires
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Kantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSB

Aarau, Canton of Aargau, Switzerland, 5001

Actively Recruiting

2

Universitätsspital Bern

Bern, Switzerland, 3010

Not Yet Recruiting

3

Universitätsspital Zürich

Zurich, Switzerland, 8091

Not Yet Recruiting

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Research Team

S

Sonja Stieb, MD

CONTACT

O

Oliver Riesterer, Prof., MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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