NCT06444776Recruiting
Therapy-Associated Saliva and Taste Change Evaluation (TASTE) in Head & Neck Cancer Patients Undergoing Radiotherapy
Therapy-Associated Saliva and Taste Change Evaluation (TASTE) in Head & Neck Cancer
Source: ClinicalTrials.gov · Last updated 6 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 30 May 2024
- Start date
- 19 Dec 2022
- Primary completion date
- Oct 2025
- Lead sponsor
- Sonja Stieb, MD
- Diseases
- Head and neck cancer
- NCT number
- NCT06444776
What you commit to
- Study type: Observational
- Planned participants: 150
- From 19 Dec 2022 to the primary completion date, Oct 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pre-existing subjective complete loss of taste before start of radiation therapy
- Planning CT and radiation therapy with oral stent or spacer
Other
- Pregnancy
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSB Coordinator of this site? Confirm its status | Aarau | Switzerland | Recruiting |
| Universitatsspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Not yet recruiting |
| Universitätsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.