Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638216
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-06
Brief Title:
Prospective Evaluation of Frailty in Patients with Head and Neck Tumors Before Curative Intended Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Evaluation of Frailty in Patients with Head and Neck Tumors Before Curative Intended Therapy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRE-KOVERI
Brief Summary:
In a prospective study the fragility of patients with head and neck tumors before the start of curative therapy will be assessed
Primary objective Fragility is assessed using the G8 questionnaire
Secondary objectives include the assessment of quality of life and financial burden EORTC-QLQ C30 HN43 swallowing function cardiopulmonary resilience 6-minute walk test and the patients wishes regarding a prehabilitation program Epidemiological and disease-related data is also collected
Primary objective Fragility is assessed using the G8 questionnaire
Secondary objectives include the assessment of quality of life and financial burden EORTC-QLQ C30 HN43 swallowing function cardiopulmonary resilience 6-minute walk test and the patients wishes regarding a prehabilitation program Epidemiological and disease-related data is also collected
Detailed Description:
In this prospective study patients with a tumor of the head and neck region that are planned for Surgery or radiotherapy chemotherapy will be included The probability of developing therapy-associated side effects is significantly increased if the patient is already in a limited general condition also known as fragility before the therapy In addition due to demographic change the incidence of head and neck tumors will continue to increase especially in patients of advanced age Due to their age other pre-existing conditions and infirmity they are at a further increased risk of therapy-related side effects In order to improve the care of patients with head and neck tumors we must first determine how many patients are affected by fragility In addition we want to determine influencing factors that are associated with fragility These include for example difficulty swallowing and weight loss Based on this data we will then plan the implementation of an intervention study to establish a prehabilitation program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None