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

NCT06367257 | Recruiting

• 1 other identifier: Emento App
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (1)

• Change in rates of weight loss with additional app-based Patient Care

  during trial, about 24 months

Secondary Outcomes (10)

• 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

Study Arms (2)

App Usage

EXPERIMENTAL

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

Standard

OTHER

Patients in the control arm receive supportive care during and after radio(chemo)therapy according to hospital standards.

Other: Standard of Care

Interventions

App Usage PROCEDURE

Conducting patient surveys with app

App Usage

Standard of Care OTHER

supportive care during and after radio(chemo)therapy according to hospial standards

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who are represented by a legal guardian
• Patients who are not suitable for participation in the study due to a language barrier

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marlen Haderlein, PD

  Universitätsklinikum Erlangen, Radiation Oncology

  STUDY DIRECTOR

• Luitpold Distel, Prof.

  Universitätsklinikum Erlangen, Radiation Oncology

  STUDY DIRECTOR

• Allison Lamrani

  Universitätsklinikum Erlangen, Radiation Oncology

  PRINCIPAL INVESTIGATOR

• Charlotte Schmitter, Dr.

  Universitätsklinikum Erlangen, Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Studiensekretariat

CONTACT

+49913185; studiensekretariat.ST@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 16, 2024
• Study Start: February 29, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)