RecruitingNAINTERVENTIONAL

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

This study is for people in the UK with head and neck cancer who are having radiotherapy or a mix of radiotherapy and chemotherapy. The main goal is to see if using a special app can help them keep track of what they eat and how much they weigh. Missing meals and losing weight can be a big problem during cancer treatment, so the study wants to find ways to reduce this and help people stay as healthy as possible. Participants will either use the app to help manage their diet or receive standard care. Information about their diet and weight will be collected throughout their treatment and for eight weeks afterwards.

At a glance

Status

Recruiting

Phase

Sponsor

University of Erlangen-Nürnberg Medical School

Enrolment target

148

Start

29 Feb 2024

Estimated completion

30 Jun 2026

Squamous Cell Carcinoma of Head and Neck

What is this study about?

When you're being treated for head and neck cancer, especially with radiotherapy or a combination of radiotherapy and chemotherapy, it can be really tough to eat well. Treatment can cause side effects like a sore throat or difficulty swallowing, which might make you lose your appetite or make eating painful. This can lead to weight loss and poor nutrition, which can affect how you feel and how well your body recovers.

This study is looking into a new way to help people manage their diet and nutrition during this challenging time. It involves using a special app on your smartphone called Emento. The app is designed to remind you to eat enough calories and to ask you a few quick questions twice a week about your health and how you're feeling about food. The idea is that by keeping a close eye on your eating habits, we can catch any problems early and get you the support you need.

The main aim is to see if using this app can help reduce weight loss and prevent you from becoming undernourished during your treatment and for a period afterwards. Researchers will compare people who use the app with those who receive the usual care, to see if the app makes a real difference in helping people maintain a good nutritional status.

Key takeaways

This study explores using a smartphone app to help track and improve nutrition for head and neck cancer patients.
It aims to reduce weight loss and malnutrition during and after radiotherapy.
Participants will either use the Emento app or receive standard care.
The app includes daily reminders and twice-weekly health check-ins.
Serious concerns identified by the app will be reported to your medical team.
The study lasts through treatment and for eight weeks post-radiotherapy.

Who may be eligible?

To take part in this study, you need to be an adult of 18 years or older who has been diagnosed with a type of head and neck cancer called squamous cell carcinoma. You must be planned to have radiotherapy or a combination of radiotherapy and chemotherapy as part of your treatment, either after surgery or as your main treatment.

Crucially, you'll need to own a smartphone and be able to install and use the Emento app on it. This is because the app is a key part of how the study works.

Things that would mean you can't join include if a legal guardian makes decisions for you, or if language difficulties would make it too hard for you to understand and take part in the study properly.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have squamous cell carcinoma of the head and neck.
I am having radiotherapy (with or without chemotherapy).
I am 18 years old or older.
I own and can use a smartphone to access an app.
I do not have a legal guardian making decisions for me.
I am comfortable communicating in English.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll either be asked to use a specific app on your smartphone or you'll receive the usual care you would normally get for your condition. If you're in the group using the app, you'll get daily reminders to help you remember to eat enough calories. Twice a week, you'll also answer three quick questions through the app about your health and how you're eating.

If your answers suggest there might be a problem with your eating or health, the app will ask you more specific questions about any side effects you might be having, like difficulty swallowing or pain. If these concerns are serious, the app will let your radiotherapy clinic know, and you'll be advised to see your doctor at the clinic as soon as possible. The study will track your nutritional status and diet regularly throughout your treatment and for eight weeks after your radiotherapy has finished. There are no specific study visits or medications involved beyond your regular care.

Potential risks and benefits

Taking part in this study could potentially help you manage your nutrition better during a challenging time, possibly reducing weight loss and helping you feel stronger. The main risk is that the app might not be effective for everyone, or it might create a slight extra daily task. However, if the app detects a problem, it will alert your care team, which could lead to earlier support. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Universitätsklinikum Erlangen, Strahlenklinik
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What kind of cancer is this study for?

This study is specifically for a type of head and neck cancer called squamous cell carcinoma.

Do I need a special phone for this study?

Yes, you need a smartphone where you can install and use the Emento app.

What is the main goal of the study?

The goal is to see if using an app can help reduce weight loss and improve nutrition for people undergoing head and neck cancer treatment.

How long will I be involved in the study?

You'll be involved during your treatment and for about eight weeks after your radiotherapy ends.

What happens if the app shows a problem?

The app will ask more questions, and if needed, your radiotherapy clinic will be informed so you can get medical advice.

How to find out more

Studiensekretariat

studiensekretariat.st@uk-erlangen.de +49913185 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.