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

Squamous Cell Carcinoma of Head and Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367257
• Other study ID #: Emento App
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Studiensekretariat
• Phone: +49913185
• Email: studiensekretariat.ST[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: June 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Procedure:
• App Usage
Conducting patient surveys with app

Other:
• Standard of Care
supportive care during and after radio(chemo)therapy according to hospial standards

Locations

Country	Name	City	State
Germany	Universitätsklinikum Erlangen, Strahlenklinik	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

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