Solheim 2018.

Study name	Cancer cachexia: rationale for the MENAC (Multimodal‐Exercise, Nutrition and Anti‐inflammatory medication for Cachexia) trial
Methods	Study design: parallel randomised controlled trial, multicentre Study dates: 5 January 2015 to December 2020 Country: Canada, Germany, Norway, Switzerland, the UK
Participants	Inclusion criteria: diagnosis of lung cancer, pancreatic cancer or cholangiocarcinoma where the diagnosis is based on histological, radiological or multidisciplinary team evaluation; non‐small cell lung cancer (stage III or IV), pancreatic adenocarcinoma (stage III or IV), due to commence first‐ or second‐line anticancer treatment (defined as chemotherapy, chemoradiotherapy, targeted therapy or immunotherapy); staging CT within 4 weeks of commencement of anticancer therapy (in patients where staging CT is without this period, further CT scanning will be undertaken. PET‐CT is also appropriate); completed all other baseline assessments within 1 week prior to first course of anticancer treatment; written informed consent; able to comply with trial interventions (in the opinion of referring clinician), e.g. willing and able to do light exercise and take oral nutritional supplements as well as no major contraindications against ibuprofen; Karnofsky Performance Status > 70 Exclusion criteria: neuro‐endocrine pancreatic cancer; creatinine clearance < 30 mL/minute; receiving parenteral nutrition or enteral nutrition via feeding tube; receiving neo‐adjuvant anticancer therapy; BMI > 30 kg/m2; use of appetite stimulants or anabolic/anticatabolic agents (such as megestrol acetate, progestational agents, marijuana growth hormone, dronabinol or other anabolic agent) within 30 days prior to study baseline; concomitant steroid (prednisolone > 10 mg/day or equivalent) treatment for < 3 months prior to inclusion (inhaled, optical or pulsed oral steroids (up to 10 days use) are permitted); concomitant long‐term (> 1 week) non‐steroidal anti‐inflammatory drugs or aspirin treatment; pregnancy, breast‐feeding or of child‐bearing potential (that is not postmenopausal or permanently sterilised) age and not using adequate contraception (oral, injected, implanted or hormonal methods of contraception, intrauterine device and barrier method); concomitant anticoagulant treatment (e.g. warfarin or heparin) Sample size: 240 participants
Interventions	Experimental group: usual care plus multimodal intervention consisting of nutritional supplements and advice, home‐based self‐assisted exercise programme, and anti‐inflammatory medication (ibuprofen) Comparator group: usual palliative care
Outcomes	Weight loss How measured: CT scan Time point measured: week 0, week 3, week 6 and week 12 Weight gain How measured: CT scan Time point measured: week 0, week 3, week 6 and week 12 Muscle mass How measured: CT scan Time point measured: week 0, week 3, week 6 and week 12 Physical activity level How measured: ActivPAL and 6MWT Time point measured: week 0, week 3, week 6 and week 12 Patient‐reported outcome measure How measured: appetite, physical activity and fatigue using the European Organisation for the Research and treatment of Cancer Quality of Life Questionnaire C30 and Health Status (EQ‐5D‐3L). Time point measured: week 0, week 3, week 6 and week 12
Starting date	5 January 5 2015
Contact information	Trude R Balstad, PhD; trude.r.balstad@ntnu.no Tora S Solheim, MD PhD; tora.l.skeidsvoll@ntnu.no
Notes	Funding: Norwegian University of Science and Technology; St. Olavs Hospital; Oslo University Hospital; Cantonal Hospital of St. Gallen; Ottawa Regional Cancer Centre; Jewish General Hospital; Cross Cancer Institute; The Beatson West of Scotland Cancer Centre; Queen Margaret Hospital, Dunfermline; Cancer Research UK Edinburgh Centre; Malteser Krankenhaus Seliger Gerhardt; Tumor Biology Center Freiburg; Tumor Zentrum Aarau Trial register ID: NCT02330926

6MWT: six‐minute walk test; BMI: body mass index; CT: computed tomography; FAACT: Functional Assessment Anorexia/Cachexia Treatment; HRmax: maximum heart rate; PET‐CT: positron emission tomography‐computed tomography; RM: repetition maximum; RPE: rating of perceived exertion; SF‐36: 36‐item Short Form.