Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444776
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-30
Brief Title:
Therapy-Associated Saliva and Taste Change Evaluation TASTE in Head Neck Cancer Patients Undergoing Radiotherapy
Sponsor:
Sonja Stieb MD
Organization:
Kantonsspital Aarau
Study Overview
Official Title:
Therapy-Associated Saliva and Taste Change Evaluation TASTE in Head Neck Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TASTE
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 eg age sex smoking history Based on the aquired data a normal tissue complication probability model for late radiation-associated taste impairment will be develeoped
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 eg age sex smoking history Based on the aquired data a normal tissue complication probability model for late radiation-associated taste impairment will be develeoped
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None