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Trial Title:
App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy
NCT ID:
NCT06367257
Condition:
Squamous Cell Carcinoma of Head and Neck
Conditions: Official terms:
Squamous Cell Carcinoma of Head and Neck
Head and Neck Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
App Usage
Description:
Conducting patient surveys with app
Arm group label:
App Usage
Intervention type:
Other
Intervention name:
Standard of Care
Description:
supportive care during and after radio(chemo)therapy according to hospial standards
Arm group label:
Standard
Summary:
Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy
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 radio(chemo)therapy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with squamous cell carcinoma in the head and neck region, who receive a
postsurgical or definitive radio(chemo)therapy
- Patients who have a smartphone on which the Emento app can be installed
- Minimum age 18 years
Exclusion Criteria:
- Patients who are represented by a legal guardian
- Patients who are not suitable for participation in the study due to a language
barrier
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitätsklinikum Erlangen, Strahlenklinik
Address:
City:
Erlangen
Zip:
91054
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Marlen Haderlein, PD
Phone:
+49913185
Phone ext:
33968
Email:
marlen.haderlein@uk-erlangen.de
Contact backup:
Last name:
Studiensekretariat
Phone:
+49913185
Phone ext:
33968
Email:
studiensekretariat.ST@uk-erlangen.de
Investigator:
Last name:
Allison Lamrani
Email:
Principal Investigator
Investigator:
Last name:
Charlotte Schmitter, Dr.
Email:
Principal Investigator
Start date:
February 29, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
University of Erlangen-Nürnberg Medical School
Agency class:
Other
Source:
University of Erlangen-Nürnberg Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06367257
