Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06367257

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, Bavaria, 91054, Germany

Location status: Recruiting

Location contact

Allison Lamrani

PRINCIPAL_INVESTIGATOR

Charlotte Schmitter, Dr.

PRINCIPAL_INVESTIGATOR

Marlen Haderlein, PD

CONTACT

[email protected]

+49913185 ext. 33968

Studiensekretariat

CONTACT

[email protected]

+49913185 ext. 33968

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App Usage

Procedure

Conducting patient surveys with app

Standard of care

Other

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

Primary outcomes

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

    Time frame: during trial, about 24 months

Secondary outcomes

  1. Frequency of deteriorations in health status subjectively reported by patients and recorded via the app.

    Time frame: during trial, about 24 months

  2. Frequency of additional app-triggered contacts of the clinic with the patients

    Time frame: during trial, about 24 months

  3. Frequency of critical health conditions (physician-verified) detected earlier by the app.

    Time frame: during trial, about 24 months

  4. Change in quality of life measured per questionnaires

    Time frame: during trial, about 24 months

  5. Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy.

    Time frame: during trial, about 24 months

  6. Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy.

    Time frame: during trial, about 24 months

  7. Rate of therapy interruptions/discontinuations

    Time frame: during trial, about 24 months

  8. Overall survival

    Time frame: during trial, about 24 months

  9. Disease-free/progression-free survival

    Time frame: during trial, about 24 months

  10. Change of Loco-regional tumor control

    Time frame: during trial, about 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Studiensekretariat

CONTACT

[email protected]

+49913185 ext. 33968

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2024
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.