App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy

Not Applicable

Recruiting

• Conditions: Squamous Cell Carcinoma of Head and Neck

• Registration Number: NCT06367257
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief 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.

Study Timeline

• Study Start: 2024-02-29
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-04-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in rates of weight loss with additional app-based Patient Care	during trial, about 24 months

Secondary Outcome Measures

Name	Time	Method
Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy.	during trial, about 24 months
Rate of therapy interruptions/discontinuations	during trial, about 24 months
Overall survival	during trial, about 24 months
Disease-free/progression-free survival	during trial, about 24 months
Change of Loco-regional tumor control	during trial, about 24 months
Frequency of additional app-triggered contacts of the clinic with the patients	during trial, about 24 months
Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy.	during trial, about 24 months
Frequency of deteriorations in health status subjectively reported by patients and recorded via the app.	during trial, about 24 months
Frequency of critical health conditions (physician-verified) detected earlier by the app.	during trial, about 24 months
Change in quality of life measured per questionnaires	during trial, about 24 months

Trial Locations

Locations (1)

Universitätsklinikum Erlangen, Strahlenklinik; 🇩🇪 Erlangen, Bavaria, Germany