A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer

Abstract

BackgroundCancer cachexia is a syndrome of weight loss (including muscle and fat), anorexia, and decreased physical function. It has been suggested that the optimal treatment for cachexia should be a multimodal intervention. The primary aim of this study was to examine the feasibility and safety of a multimodal intervention (n‐3 polyunsaturated fatty acid nutritional supplements, exercise, and anti‐inflammatory medication: celecoxib) for cancer cachexia in patients with incurable lung or pancreatic cancer, undergoing chemotherapy.MethodsPatients receiving two cycles of standard chemotherapy were randomized to either the multimodal cachexia intervention or standard care. Primary outcome measures were feasibility assessed by recruitment, attrition, and compliance with intervention (>50% of components in >50% of patients). Key secondary outcomes were change in weight, muscle mass, physical activity, safety, and survival.ResultsThree hundred and ninety‐nine were screened resulting in 46 patients recruited (11.5%). Twenty five patients were randomized to the treatment and 21 as controls. Forty‐one completed the study (attrition rate 11%). Compliance to the individual components of the intervention was 76% for celecoxib, 60% for exercise, and 48% for nutritional supplements. As expected from the sample size, there was no statistically significant effect on physical activity or muscle mass. There were no intervention‐related Serious Adverse Events and survival was similar between the groups.ConclusionsA multimodal cachexia intervention is feasible and safe in patients with incurable lung or pancreatic cancer; however, compliance to nutritional supplements was suboptimal. A phase III study is now underway to assess fully the effect of the intervention.

Cancer cachexia: rationale for the MENAC (Multimodal—Exercise, Nutrition and Anti-inflammatory medication for Cachexia) trial

“…The advantage of giving ONS compared with capsules is that they provide extra calories, proteins and micronutrients in addition to Ω-3 fatty acids. On the other hand, low compliance with ONS has been reported,7 and therefore alternative forms of administration of Ω-3 fatty acids can be advantageous for the patients to ensure good compliance.…”

“…However, the evidence to support such a multimodal approach is lacking. We have recently completed a feasibility trial of a multimodal cachexia intervention, termed the preMENAC trial 7. This was a randomised, phase II, 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 patients with advanced cancer undergoing chemotherapy (clinicaltrials.gov ID; NCT01419145).…”

Palliative stenting for oesophagogastric cancer: tumour and host factors and prognosis

“…Eighty percent of patients were diagnosed with an oesophageal or junctional cancer, with metastatic disease evident in 40% of cases. Median CRP was 29mg/L (interquartile range 13-74), and median albumin was 31g/L (26)(27)(28)(29)(30)(31)(32)(33)(34)(35)). An elevated CRP (>10mg/L) was present in 78% of patients, and a low albumin (<35g/L) was identified in 75% of patients.…”

“…[29][30][31] In keeping with this, a multi-modality approach incorporating non-steroidal anti-inflammatory drugs and nutritional support has been shown to be feasible in patients with advanced cancer. [32] The presently recruiting MENAC trial aims to investigate the effects of such an intervention on body composition and performance status in patients receiving palliative chemotherapy for advanced pancreatic and lung cancer. [33] It would be of interest to examine such an approach in the context of the palliation of oesophago-gastric cancer; indeed, whether the assessment of systemic inflammatory profiles and performance status would not only guide prognosis but also allow for stratification of palliative therapy options remains of interest and warrants further study.…”

More variety with the Journal of Cachexia, Sarcopenia and Muscle: JCSM Clinical Reports and JCSM Rapid Communications have both gone live

“…For the main JCSM journal, clinical trials,2, 3, 4, 5, 6 disease definition and regulatory issues,7, 8, 9, 10 epidemiological reports of broad interest,11, 12, 13 and significant basic science mechanistic insights14, 15, 16 as well as studies on pathophysiology questions17, 18, 19 will remain the main domain of what we aim to publish, but there are so many more things that deserve to be published and often only by a small margin don't make it into JCSM . We have a rejection rate for original reports that is >80%.…”