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RecruitingNCT06367257Updated Jul 31, 2026

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

An interventional study of App Usage and Standard of Care in Squamous Cell Carcinoma of Head and Neck, sponsored by University of Erlangen-Nürnberg Medical School. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Squamous Cell Carcinoma of Head and Neck
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
148 participants (estimated)

Study arms

  • 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

  • Other
    Standard

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

    Other: Standard of Care

Interventions

  • ProcedureApp Usage

    Conducting patient surveys with app

  • OtherStandard of Care

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

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
  • Universitätsklinikum Erlangen, Strahlenklinik
    Erlangen, Bavaria 91054, Germany
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06367257
Lead sponsor
University of Erlangen-Nürnberg Medical School
Responsible party
Sponsor
First posted
Apr 16, 2024
Start date
Feb 29, 2024
Primary completion
Apr 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jul 31, 2026

Study contacts

Studiensekretariat
Contact
studiensekretariat.ST@uk-erlangen.de
+49913185 ext. 33968
Marlen Haderlein, PD
study director · Universitätsklinikum Erlangen, Radiation Oncology
Luitpold Distel, Prof.
study director · Universitätsklinikum Erlangen, Radiation Oncology
Allison Lamrani
principal investigator · Universitätsklinikum Erlangen, Radiation Oncology
Charlotte Schmitter, Dr.
principal investigator · Universitätsklinikum Erlangen, Radiation Oncology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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