The MENAC Trial
Research type
Research Study
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.
IRAS ID
193580
Contact name
Barry Laird
Contact email
Sponsor organisation
Norwegian University of Science and technology
Eudract number
2013-002282-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 30 days
Research summary
Summary of Research
Cancer cachexia is common in pancreatic and lung cancer patients where mean survival is less than one year. Currently there is no standard care for cachexia which has been shown to improve symptoms.The physical symptoms of cachexia are muscle wasting, reduced physical activity, negative energy/protein balance, causing fatigue and general increased inflammation.
The MENAC study will investigate if symptoms can be reversed by using a combination of interventions such as nutritional supplements including omega-3 fatty acids, an exercise programme and an anti-inflammatory drug. All of which will be taken from the start of chemotherapy cancer treatment.A pilot study in a small number of patients (preMENAC Study NCT01419145) has indicated that this combination of treatments may be effective in patients undergoing palliative chemotherapy. Results from the pilot study showed that patients given the combined treatment weighed on average 2.85Kg heavier at 6 weeks compared to the control group. We now want to see if this effect can be replicated in a bigger population to confirm the findings.
240 patients with incurable lung or pancreatic cancer due to begin anti-cancer chemotherapy will be recruited and randomised to receive either; the combined treatment and standard care or standard care alone from the first day of chemotherapy. Patients randomised to treatment will have the combined treatment for 12 weeks in total, and those patients on standard care will be offered the combined treatment after 6 weeks.
Differences between the groups will be measured at 3, 6 and 12 weeks. The main difference looked at will be patient weight, but we will also look at muscle mass, physical function, quality of life and costs
The trial is already recruiting in hospitals in Norway and will recruit from seven UK hospitals. The UK hospitals are expected to recruit 154 patients of the 240 needed.
Summary of Results
Background: Cancer cachexia arises from the interaction between the host and the tumour, triggering an inflammatory response that leads to weight and appetite loss, diminished physical activity, reduced treatment efficacy and survival. Combining interventions to address inflammation, weight loss, and physical activity is proposed as an effective strategy. Building on a promising pilot study, we conducted the MENAC (Multimodal Exercise Nutrition Anti-inflammatory Cachexia) trial to comprehensively evaluate this approach in patients with lung and pancreatic cancer undergoing systemic anti-cancer treatment (SACT).
Methods: MENAC was an investigator-initiated, multicentre, open label, randomised phase 3 trial conducted at 17 sites in 4 countries. Patients with stage III or IV lung or pancreatic cancer receiving SACT with non-curative intent were randomly assigned (1: 1) to a multimodal intervention consisting of nutritional counselling plus fish oil containing oral nutritional supplements, physical exercise [endurance and strength] and non-steroidal anti-inflammatory drugs [NSAIDs]) versus standard care. Randomisation was stratified by country, cancer type and stage.
Primary Objective: To assess differences between arms in change in body weight. Secondary Objectives: To assess differences in muscle mass (measured by CT L3 technique) and physical activity (assessed through step counts using ActivPAL activity meter) between arms.
Assessments were conducted at basline (pre-randomisation) and at endpoint (after 6 weeks).
Trial Registration: ClinicalTrials.gov ID: NCT02330926.
Results: From May 2015 to February 2022, 212 patients were enrolled (105 to multimodal treatment, 107 standard care). Over 6 weeks, weight stabilised in patients assigned to multimodal treatment compared with those assigned to standard care (mean weight change [SD] 0.05 kg [3.8] vs – 0.99 kg [3.2], respectively) with a mean difference in weight change of -1.04kg, 95 % CI -2.02 to -0.06, p=0.04. There was no conclusive difference in muscle mass (mean change [SD] -6.5cm2 [ 10.1] vs -6.3cm2 [11.9], p=0.93) or in mean step counts [SD] (-377.7 [2075] vs -458 [1858], p=0.89). There were 28 and 24 reported SAEs in the intervention and control arm respectively, no SUSARs were reported.
Conclusion: A multimodal cachexia intervention stabilised weight compared to standard care at six weeks. There was no difference in physical activity or muscle mass between trial arms.REC name
West of Scotland REC 1
REC reference
16/WS/0057
Date of REC Opinion
17 May 2016
REC opinion
Further Information Favourable Opinion