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

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Squamous Cell Carcinoma of Head and Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

App Usage

Intervention Type PROCEDURE

Conducting patient surveys with app

Standard

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

Group Type OTHER

Standard of Care

Intervention Type OTHER

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

Interventions

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App Usage

Conducting patient surveys with app

Intervention Type PROCEDURE

Standard of Care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marlen Haderlein, PD

Role: STUDY_DIRECTOR

Universitätsklinikum Erlangen, Radiation Oncology

Luitpold Distel, Prof.

Role: STUDY_DIRECTOR

Universitätsklinikum Erlangen, Radiation Oncology

Allison Lamrani

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Erlangen, Radiation Oncology

Charlotte Schmitter, Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Erlangen, Radiation Oncology

Locations

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Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Studiensekretariat

Role: CONTACT

+49913185 ext. 33968

Facility Contacts

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Marlen Haderlein, PD

Role: primary

+49913185 ext. 33968

Studiensekretariat

Role: backup

+49913185 ext. 33968

Other Identifiers

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Emento App

Identifier Type: -

Identifier Source: org_study_id

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