Clinical trial NCT06367257: App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy
Official title: App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Squamous Cell Carcinoma of Head and Neck
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in rates of weight loss with additional app-based Patient Care
timeFrame: during trial, about 24 months
Secondary outcomes:
measure: Frequency of deteriorations in health status subjectively reported by patients and recorded via the app.
timeFrame: during trial, about 24 months
measure: Frequency of additional app-triggered contacts of the clinic with the patients
timeFrame: during trial, about 24 months
measure: Frequency of critical health conditions (physician-verified) detected earlier by the app.
timeFrame: during trial, about 24 months
measure: Change in quality of life measured per questionnaires
timeFrame: during trial, about 24 months
measure: Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy.
timeFrame: during trial, about 24 months
measure: Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy.
timeFrame: during trial, about 24 months
measure: Rate of therapy interruptions/discontinuations
timeFrame: during trial, about 24 months
measure: Overall survival
timeFrame: during trial, about 24 months
measure: Disease-free/progression-free survival
timeFrame: during trial, about 24 months
measure: Change of Loco-regional tumor control
timeFrame: during trial, about 24 months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Strahlenklinik
state: Bavaria
Study officials:
affiliation: Universitätsklinikum Erlangen, Radiation Oncology
name: Marlen Haderlein, PD
role: STUDY_DIRECTOR
affiliation: Universitätsklinikum Erlangen, Radiation Oncology
name: Luitpold Distel, Prof.
role: STUDY_DIRECTOR
affiliation: Universitätsklinikum Erlangen, Radiation Oncology
name: Allison Lamrani
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Erlangen, Radiation Oncology
name: Charlotte Schmitter, Dr.
role: PRINCIPAL_INVESTIGATOR
References: