A trial looking at inhalers to relieve breathlessness for people with lung cancer - ADOPT
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at using inhalers to help relieve in people with lung cancer.
More about this trial
There are many reasons why people with lung cancer may be breathless. One reason is that they may also have a condition called chronic obstructive pulmonary disease – COPD.
COPD causes the airways to narrow making it harder for the air to get in and out of the lungs and so causing breathlessness. We know that people who have COPD get some benefit from using inhalers. The researchers think inhalers may help people who have lung cancer and COPD.
The aim of this trial is to find out if using inhalers is better than best supportive care at improving breathlessness in people who have lung cancer and COPD.
Who can enter
You can enter this trial if you
- Have non small cell lung cancer, small cell lung cancer or mesothelioma
- Have chronic obstructive pulmonary disease (COPD) – your doctor can advise you about this
- Have moderate or severe breathlessness
- Are over 35 years old
You cannot enter this trial if you
- Are having treatment or are going to start treatment in the next 4 weeks (if you have had at least 2 cycles of chemotherapy or a taking a biological therapy drug such as erlotinib you may be able to take part - your doctor can advise about this)
- Are taking drugs to open up your airways (bronchodilators),unless they only work for a short period of time– your doctor can advise you about this
- Have started to take steroid tablets in the last week
- Have breathing problems that can be reversed such as a chest infection or fluid on the lung
- Have asthma
- Have had a heart attack in the last 6 weeks or any other heart problem that is a cause for concern
- Have kidney failure
- Have problems with your
prostate - Have difficulty passing urine
- Have or have had tuberculosis (TB)
- Have an eye problem called glaucoma
- Have an overactive
thyroid - Are allergic to milk or other dairy products – lactose allergy
- Are sensitive to the medications used in this trial – your doctor can advise about his
- Are taking any medications that could affect you taking part in this trial – your doctor can advise you about this
- Are pregnant
Trial design
This trial will recruit 72 people who are attending the Royal Marsden Hospital. It is a randomised trial. The people taking part will be put into 1 of 2 groups. Neither you nor your doctor can choose which group you are in.
If you are in group 1 you will have .
If you are in group 2 you will have best supportive care and the use of inhalers to help your breathlessness.
How many inhalers you use will depend on how breathless you are. The researchers will do some tests to find out how bad your breathlessness is.
Everyone in group 2 will have at least 2 inhalers. One you take 4 times a day and the other once a day. You may have a third inhaler, which you take twice a day. The research team will teach you how to use the inhalers.
You use the inhalers for 4 weeks. If they are helping you, the researchers will write to your GP and recommend that you continue to use them.
The research team will ask you to fill in 2 questionnaires at the beginning of the trial and after 4 weeks. The questionnaires will ask how your breathlessness is affecting your quality of life and levels of activity.
Hospital visits
You will see your doctor and have some tests before taking part in this trial. These test include
- A physical examination
- Chest X-ray
- Heart trace –
ECG - Urine test
- Blood tests
- Breathing test –
Lung function tests - A 6 minute walking test
The researchers will also ask you to mark on a line how breathless you feel. This is called a visual analogue scale (VAS). The team will explain this to you.
You see the doctor again at 2 and 4 weeks. As much as possible the team will schedule these visits for the days you usually attend the clinic to see your doctor.
Side effects
The most common side effects of the drugs used in this trial are
- Feeling shaky
- Headache
- Sore mouth and throat
- White patches in the mouth –
thrush - Muscle cramps
- Tightness of the chest
- Hoarse voice
- Fast heart beat
- Rash
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Mary O’Brien
Supported by
The Alan J Lerner Research Fund
The Royal Marsden NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040