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

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.

Study Overview

• Status: Recruiting
• Conditions: Squamous Cell Carcinoma of Head and Neck
• Intervention / Treatment: Procedure: App Usage; Other: Standard of Care

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 Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Studiensekretariat; Phone Number: 33968 +49913185; Email: studiensekretariat.ST@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Universitätsklinikum Erlangen, Strahlenklinik
      • Contact: Marlen Haderlein, PD; Phone Number: 33968 +49913185; Email: marlen.haderlein@uk-erlangen.de
      • Contact: Studiensekretariat; Phone Number: 33968 +49913185; Email: studiensekretariat.ST@uk-erlangen.de
      • Contact: Allison Lamrani
      • Contact: Charlotte Schmitter, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App Usage; Patients receive the daily reminder message via app (Emento) that they should pay attention to sufficient calorie intake. In addition, these patients receive 3 screening questions about their current health and nutritional status twice a week.	Procedure: App Usage; Conducting patient surveys with app
Other: Standard; Patients in the control arm receive supportive care during and after radio(chemo)therapy according to hospital standards.	Other: Standard of Care; supportive care during and after radio(chemo)therapy according to hospial standards

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of deteriorations in health status subjectively reported by patients and recorded via the app.	during trial, about 24 months
Frequency of additional app-triggered contacts of the clinic with the patients	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
Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy.	during trial, about 24 months
Change of course 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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Study Director: Marlen Haderlein, PD, Universitätsklinikum Erlangen, Radiation Oncology; Study Director: Luitpold Distel, Prof., Universitätsklinikum Erlangen, Radiation Oncology; Principal Investigator: Allison Lamrani, Universitätsklinikum Erlangen, Radiation Oncology; Principal Investigator: Charlotte Schmitter, Dr., Universitätsklinikum Erlangen, Radiation Oncology

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms
• Other Study ID Numbers: Emento App

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No