Squamous Cell Carcinoma of Head and NeckNCT06367257
App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy
A study testing App Usage in people with Squamous Cell Carcinoma of Head and Neck, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- App Usage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteGermany
- Study dates
- 29 Feb 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who are represented by a legal guardian
- Patients who are not suitable for participation in the study due to a language barrier
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Bavaria, 91054
Marlen Haderlein, PD, +49913185 ext. 33968, marlen.haderlein@uk-erlangen.de
Studiensekretariat, +49913185 ext. 33968, studiensekretariat.ST@uk-erlangen.de
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.
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.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- App Usage, Standard of Care
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App UsageProcedure or surgery
Conducting patient surveys with app
Standard of CareOther
supportive care during and after radio(chemo)therapy according to hospial standards
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: App Usage |
| Standard | Other | Patients in the control arm receive supportive care during and after radio(chemo)therapy according to hospital standards. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rates of weight loss with additional app-based Patient Care
Measured: during trial, about 24 months
Secondary outcomes (10)
Frequency of deteriorations in health status subjectively reported by patients and recorded via the app.
Measured: during trial, about 24 months
Frequency of additional app-triggered contacts of the clinic with the patients
Measured: during trial, about 24 months
Frequency of critical health conditions (physician-verified) detected earlier by the app.
Measured: during trial, about 24 months
Change in quality of life measured per questionnaires
Measured: during trial, about 24 months
Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy.
Measured: during trial, about 24 months
Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy.
Measured: during trial, about 24 months
Rate of therapy interruptions/discontinuations
Measured: during trial, about 24 months
Overall survival
Measured: during trial, about 24 months
Disease-free/progression-free survival
Measured: during trial, about 24 months
Change of Loco-regional tumor control
Measured: during trial, about 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start29 Feb 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlen Haderlein, PD, Study director, Universitätsklinikum Erlangen, Radiation OncologyLuitpold Distel, Prof., Study director, Universitätsklinikum Erlangen, Radiation OncologyAllison Lamrani, Principal investigator, Universitätsklinikum Erlangen, Radiation OncologyCharlotte Schmitter, Dr., Principal investigator, Universitätsklinikum Erlangen, Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367257
- Sponsor's protocol ID
- Emento App
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy
- ClinicalTrials.gov ID
- NCT06367257
- Acronym / sponsor ID
- Emento App
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App Usage | Experimental | Procedure: App UsagePatients 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. |
| Standard | Other | Other: Standard of CarePatients in the control arm receive supportive care during and after radio(chemo)therapy according to hospital standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who are represented by a legal guardian
- Patients who are not suitable for participation in the study due to a language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App UsageConducting patient surveys with app | Procedure or surgery | App Usage |
| Standard of Caresupportive care during and after radio(chemo)therapy according to hospial standards | Other | Standard |
Primary outcome
Change in rates of weight loss with additional app-based Patient Care
Time frame: during trial, about 24 months
10 secondary outcomes
Frequency of deteriorations in health status subjectively reported by patients and recorded via the app.
Time frame: during trial, about 24 months
Frequency of additional app-triggered contacts of the clinic with the patients
Time frame: during trial, about 24 months
Frequency of critical health conditions (physician-verified) detected earlier by the app.
Time frame: during trial, about 24 months
Change in quality of life measured per questionnaires
Time frame: during trial, about 24 months
Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy.
Time frame: during trial, about 24 months
Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy.
Time frame: during trial, about 24 months
Rate of therapy interruptions/discontinuations
Time frame: during trial, about 24 months
Overall survival
Time frame: during trial, about 24 months
Disease-free/progression-free survival
Time frame: during trial, about 24 months
Change of Loco-regional tumor control
Time frame: during trial, about 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App Usage in people with Squamous Cell Carcinoma of Head and Neck, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Studiensekretariat (+49913185 ext. 33968, studiensekretariat.ST@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rates of weight loss with additional app-based Patient Care (time frame: during trial, about 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.