A trial looking at swallowing exercises for people with a head and neck cancer (SIP SMART 2)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Cancer of unknown primary (CUP)

Cancer spread to the bone

Head and neck cancers

Mouth (oral) cancer

Nasal and paranasal sinus cancer

Secondary cancers

Status:

Closed

Phase:

Pilot

This trial is looking at whether a programme of exercises before treatment can help people with their eating, drinking and swallowing after treatment.

More about this trial

Doctors can treat people with a head and neck cancer with:

surgery
radiotherapy
chemoradiotherapy
or a combination of the above

We know that these treatments can have a major effect on your swallowing.

The standard care to help with this is to see the speech and language therapist (SLT) after your treatment. They give everyone a general set of swallowing exercises.

Researchers think that having a swallowing package tailored for you and starting it before treatment might be better. This is SIP SMART and it involves:

an assessment of your swallowing
swallowing exercises tailored for you
advice and education from the SLT

To find this out half the people in this trial have the standard care. The other half get SIP SMART as well as standard care.

The aims of this trial are to find out whether:

SIP SMART is better than standard care to maintain swallowing after treatment
It is possible and how acceptable it is to do

Who can enter

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this trial if all of the following apply. You:

have newly diagnosed cancer of the mouth, oropharynx, nasopharynx, hypopharynx or cancer of the jaw bone. You can also join if you have an unknown primary cancer and you are to have radiotherapy to both sides of the neck.
have cancer that has spread to the nearby tissue or has spread to another part of the body
are to have surgery, radiotherapy, chemoradiotherapy or a combination of these with the aim to cure
are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply. You:

have had a head and neck cancer before
have another primary cancer within the head and neck area. This could be salivary gland cancer, laryngeal cancer or cancer affecting the ear.
have a brain tumour
have already started treatment including treatment to relieve symptoms (palliative)
are only to have one type of treatment that is not a standard treatment such as photodynamic therapy or brachytherapy
are having chemotherapy by itself
are to have all of your voice box removed (a total laryngectomy)
are to have a tube in your neck (tracheostomy) to breathe through for the long term
are in bed or a chair all the time and need complete care (performance status 4)
have a long term problem with speech and comprehension caused by disease or damage to the brain such as a stroke
have any other medical condition or mental health problem that could affect you taking part

Trial design

This is a pilot trial. The team need between 72 and 90 people to join.

It is a cluster randomised trial. Which group you are in depends on which hospital you are having treatment at. The 2 groups are:

SIP SMART and standard treatment
standard treatment

The speech and language therapist (SLT) with the research nurse sees you before the start of your treatment. They will ask a few questions and get some information from your medical notes.

SIP SMART
For those in this group you have:

an x-ray taken of when you swallow
an extra visit to the SLT
tailored swallowing exercises to do before starting treatment with advice and education on maintaining your swallowing

The extra visit is for the x-ray swallow and for SLT to explain your specific swallowing exercises.

Standard care
In this group you see the SLT according to the standard care at your hospital..

Quality of life
You fill in questionnaires:

before you start treatment
then after treatment at
1 month
3 months
6 months

The questions ask about:

your swallowing
your general health and wellbeing
side effects of treatment

These are quality of life questionnaires.

At the same time you also fill in a questionnaire about how often you have seen a health professional who isn’t part of your hospital care team. Examples of these professionals are your GP or a community nurse.

You might be able to fill these questions in online.