The positive effect of our feasibility trial provides grounds that cachexia (wasting) does not need to be an inevitable consequence of advanced cancer
The MENAC trial: a randomised, open-label trial of a Multimodal Intervention (Exercise, Nutrition and Anti-inflammatory Medication) plus standard care vs standard care alone to prevent cachexia in advanced cancer patients undergoing Chemotherapy
Patients with cancer frequently experience weight loss, which can cause decreased physical function, shortened survival and an overall reduced quality of life. It can follow as a consequence of cancer cachexia. Cancer cachexia is a wasting syndrome that develops by a combination of reduced food intake and the body’s altered ability to utilise nutrients arising from interactions between cancer-induced inflammation, hormonal changes, increased muscle protein breakdown and reduced ability to build and maintain muscle and fat mass.
Despite increased understanding of the mechanisms of cachexia, there are no standardised practices for management. Ensuring food intake to avoid negative energy and protein balance is thought to be central in the treatment of cancer cachexia, and combining counselling with oral nutritional supplements has previously shown positive effect on body weight and quality of life. Physical exercise is essential for maintaining muscle mass and can improve muscle strength during cancer treatment.
Previous research suggests that anti-inflammatory drugs such as ibuprofen and omega-3 fatty acids from fish oil may have a positive effect on muscle mass and body weight. The MENAC trial looks at Multimodal-Exercise, Nutrition and Anti-inflammatory medication for Cachexia. Our trial will evaluate the implementation and effect of nutritional counselling and supplements containing omega-3 fatty acids, exercise and anti-inflammatory drugs. A pilot study showed that the trial was safe and feasible, and the multifaceted intervention resulted in a maintenance of body weight.
The central hypothesis of this trial is that a multifaceted intervention, delivered during palliative chemotherapy in patients with advanced lung or pancreatic cancer, prevents the development or attenuates the effect of cancer cachexia. Direct effects from the cachexia intervention are expected to be a reduction in weight and muscle loss, an improvement in physical activity and muscle strength, and improvement in survival and quality of life.
The main objective is to test the differences between the treatments on change in body weight at six weeks after randomisation. We will test differences between the treatments on change in muscle mass and physical activity at six weeks after randomisation. We will also test differences between treatments on several exploratory outcomes at six weeks after randomisation: tolerance to anti-cancer treatment, nutritional status, appetite and food intake, performance status, physical function, quality of life and overall survival.
The MENAC trial is a randomised trial, taking place in a number of centres and clinics. It compares a multifaceted intervention, added to standard cancer care, with standard care alone, in patients with advanced lung and pancreatic cancer who are being treated with palliative chemotherapy.
Study baseline will be before chemotherapy starts, and study endpoint will be after six weeks. Assessments will also be performed after three weeks (midpoint) and at a 12 week follow-up. Currently, cancer clinics in Canada, Switzerland and Norway are including patients in the trial. In the UK, there are seven planned cancer clinics open for inclusion.
Participating patients will receive individual nutritional counselling in combination with oral nutritional supplements and will be instructed to complete a home-based exercise programme consisting of both aerobic and resistance exercises. Participating patients will be prescribed anti-inflammatory treatment with 1200mg of ibuprofen daily. The control group will receive standard cancer care for the six-week intervention period.
The positive effect of our feasibility trial (pre-MENAC) provides grounds that cachexia does not need to be an inevitable consequence of advanced cancer. Specific impact objectives include establishing a rehabilitation programme for cachexia, which can be implemented into clinical practice, and increasing public awareness of the importance of nutrition and physical exercise, during the cancer disease trajectory.
The MENAC trial has already generated great interest both within the clinical cachexia community and among clinical oncologists.
