Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06367257
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-04-03
Brief Title:
App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After RadioChemoTherapy
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
University of Erlangen-Nürnberg Medical School
Study Overview
Official Title:
App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After RadioChemoTherapy
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
Patients with head and neck cancer requiring definitive or adjuvant radiochemotherapy can take part in the study The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition
Detailed Description:
Patients with head and neck cancer requiring definitive or adjuvant radiochemotherapy can take part in the study The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition
Patients in the experimental arm receive the daily reminder message via app Emento that they should pay attention to adequate caloric intake In addition these patients receive 3 screening questions about their current health and nutritional status twice a week
In case of relevant deterioration any negative value in the screening questions is explained under study procedure additional further questions are asked which are specifically aimed at the side effects of the tumor therapy mainly dysphagia pain The answers will be transmitted to the radiation clinic
If a question is answered positively this is reported to the radiotherapy clinic on the one hand and on the other hand the patient is asked to consult the doctor in the clinic as soon as possible
Patients in the experimental arm receive the daily reminder message via app Emento that they should pay attention to adequate caloric intake In addition these patients receive 3 screening questions about their current health and nutritional status twice a week
In case of relevant deterioration any negative value in the screening questions is explained under study procedure additional further questions are asked which are specifically aimed at the side effects of the tumor therapy mainly dysphagia pain The answers will be transmitted to the radiation clinic
If a question is answered positively this is reported to the radiotherapy clinic on the one hand and on the other hand the patient is asked to consult the doctor in the clinic as soon as possible
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