A phase 3 trial looking at a combination of ways for preventing or reducing cachexia during chemotherapy for pancreatic or lung cancer (MENAC)
Full title: A randomised, open-label trial of a Multimodal Intervention (Exercise, Nutrition and Anti-inflammatory Medication) plus standard care versus standard care alone to prevent /attenuate cachexia in advanced cancer patients undergoing chemotherapy.
Why is this trial being carried out?
Cancer cachexia is a condition causing weight loss, loss of appetite and extreme tiredness (fatigue). It is common in people with pancreatic cancer and lung cancer. Cachexia can’t be cured but there are ways to manage it to improve symptoms.
The MENAC trial is a phase 3 trial for people with advanced lung cancer and advanced pancreatic cancer, who are starting chemotherapy. Pancreatic cancer that has spread from the pancreas to other parts of the body is called advanced or metastatic cancer. The aim of the trial is to prevent or reduce cachexia before it develops to an advanced stage.
Results from an earlier study showed that giving participants counselling advice, a supplement drink, ibuprofen and exercise and diet advice, helped to reduce the symptoms of cachexia. These interventions were all done before the people started chemotherapy.
Researchers now want to see if these results can be achieved in a larger sample of people with cachexia. The aim is to improve their daily quality of life both during and after chemotherapy.
The MENAC study will see if the symptoms of cachexia can be reduced by providing these combined interventions before starting chemotherapy:
- nutritional supplements and advice
- a home-based exercise programme
- an anti-inflammatory drug (called ibuprofen).
This is a randomised trial, where participants will be offered the treatment either immediately, or after six weeks. This will be in addition to their usual cancer treatment, such as chemotherapy. If you find the treatment helpful, you can continue having it after the trial ends.
The differences between the treatments will be measured at six and 12 weeks.
Who is the trial suitable for?
- have pancreatic cancer, lung cancer, or bile duct cancer (cholangiocarcinoma), and are due to start treatments, including chemotherapy or chemo-radiotherapy
- are able to do light exercise and take nutritional supplements, such as vitamins and minerals
- are not allergic to ibuprofen - the trial team will discuss this with you.
It may not suitable for you if you:
- have a pancreatic neuroendocrine tumour (PNETs)
- have a test that shows that your kidneys are not working normally
- are receiving nutrition into your bloodstream through a feeding tube (parenteral)
- are having therapy before surgery, such as chemotherapy, radiation or hormone therapy – the trial team will discuss this with you
- are taking medicines or hormone drugs to increase your appetite 30 days before the trial starts
- are taking steroids up to three months before starting the trial
- are taking aspirin or non-steroidal anti-inflammatory medications that are often used to relieve pain and long-term inflammation
- are using blood-thinning treatment (anti-coagulants), such as warfarin or heparin
- are pregnant or breast-feeding, or are not using contraception.
There may be other reasons for not being able to take part in a trial. It is important to speak to your consultant about whether this trial might be suitable for you.
Recruitment start date: April 2015
Recruitment end date: August 2019
Updated May 2018
Review date August 2021
The MENAC trial is being carried out at:
- Edinburgh Cancer Centre, Scotland
- Beatson West of Scotland Cancer Centre, Scotland
- Queen Margaret Hospital, Scotland
- Guy's and St Thomas Hospital, London
- University Hospital Llandough
Marie Fallon, University of Edinburgh, Scotland
You can contact the trial centre’s using this email address: email@example.com
How to join a trial
Please speak to your consultant about whether this trial is suitable for you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.
How to find out more
Find out more about the MENAC trial.
For references used to develop this information please email us.