The MENAC Trial - A randomised, open-label trial of a multimodal intervention (multimodal = exercise, nutrition and anti-inflammatory medication) versus standard care in cancer patients with cachexia
Automatically Closed · 2017 until 2020
Strasser Florian, Domeisen Benedetti Franzisca, Attoun-Knobel Suzanne, Behnke Nadine
Cachexia is a common detrimental consequence of cancer limiting therapy, quality of life and survival. There is no standard treatment available and its complex multifactorial pathophysiology requires multimodal treatment. Based on promising phase II results (n=60) the MENAC, an international Phase III trial is planned. Advanced lung cancer or pancreatic cancer patients not eligible for curative therapy with a Karnofsky Performance Score ≥ 70 are eligible at start of anti-cancer treatment. The treatment encompasses nutritional supplements (eicosapentaenoic acid) and counselling, home-based self-assisted exercise program and anti-inflammatory medication (ibuprofen).The primary objective of the study is to establish whether a multimodal intervention is effective in treating cachexia. The primary objective is to establish whether a multimodal intervention is effective in maintaining body weight in patients undergoing palliative chemotherapy. Secondary endpoints include muscle mass, (CT-derived) are physical function assessed using 6 minute walk test, nutritional status: patient-generated subjective global assessment (PG-SGA), AveS and 24 hour recall, appetite, fatigue (EORTC QLQ-C30), tolerance of and response to anti-cancer therapy and survival. The satisfaction of patients with multimodal treatment will be measured (FACIT-TS-PS).
Based on current data from the Pre-MENAC pilot suggesting ~25% attrition to obtain 180 patients will require recruitment of 240 patients in order to detect an SD of 0.5 on CT-derived muscle mass at week 6 using a two-sample t-test with power 0.9 and alpha 0.05. The estimated inclusion at KSSG is 25 to 35 patients per year.
The MENAC is a delayed intervention trial with duration of 6 weeks (intervention)/ 12 weeks in total. Patients will be randomised to enter either the treatment arm or the control arm and will remain in this for 6 weeks. After 6 weeks, the control group receive the same treatment as the intervention group. The trial is performed by the European Association for Palliative Care Research Network as an international collaborative effort and is considered to be the industry independent landmark trial in a field where local expertise is present.