JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

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NCT-Nummer:
NCT06367257

Studienbeginn:
Mai 2024

Letztes Update:
16.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Erlangen-Nürnberg Medical School

Collaborator:
-

Studienleiter

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

Marlen Haderlein, PD
Study Director
Universitätsklinikum Erlangen, Radiation Oncology

Kontakt

Studiensekretariat
Kontakt:
Phone: +49913185
Phone (ext.): 33968
E-Mail: studiensekretariat.ST@uk-erlangen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Universitätsklinikum Erlangen, Strahlenklinik
91054 Erlangen
(Bayern)
Germany» Google-Maps
Ansprechpartner:
Marlen Haderlein, PD
Phone: +49913185
Phone (ext.): 33968
E-Mail: marlen.haderlein@uk-erlangen.de

Studiensekretariat
Phone: +49913185
Phone (ext.): 33968
E-Mail: studiensekretariat.ST@uk-erlangen.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Change in rates of weight loss with additional app-based Patient Care (Time Frame - during trial, about 24 months)

Secondary outcome:

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)

Studien-Arme

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

Geprüfte Regime

App Usage:
Conducting patient surveys with app
Standard of Care:
supportive care during and after radio(chemo)therapy according to hospial standards

Quelle: ClinicalTrials.gov

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