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
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 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.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 148 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →University of Erlangen-Nürnberg Medical School is the lead sponsor of 276 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
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
Patients in the control arm receive supportive care during and after radio(chemo)therapy according to hospital standards.
Other: Standard of Care
Conducting patient surveys with app
supportive care during and after radio(chemo)therapy according to hospial standards
Change in rates of weight loss with additional app-based Patient Care
Time frame: during trial, about 24 months
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
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Apr 2027, 38 months after the start.
Of 115 non-industry interventional studies with no phase under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 90. This study's planned 38 months is below that.
Counting every sponsor, half of 126 studies reached it within 59 months; a quarter within 34 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
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