last updated at 18.08.2019

MENAC

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.

Status: Aktiv

ISRCTN EudraCT Clinicaltrials.gov DRKS
2013-002282-19 NCT02330926

Diagnose

  • Anorexia nervosa
  • Gallenblasenkarzinom
  • Lungencarcinom
  • Pankreaskarzinom (Bauchspeicheldrüsenkrebs)
  • Various cancer types

Studienziel / Fragestellung

Primäres Prüfziel
  • Body weight – difference between intervention and control group at study endpoint (T2)

Sekundäre Prüfziele
  • All endpoints will be assessed at T2 between the two groups
    Muscle Mass: difference using CT L3 technique
    Physical activity: difference in step count assessed by ActivPAL

Patientenmerkmale

Alter

-

Ausschlusskriterien

     

  • Neuro-endocrine pancreatic cancer
  • Creatinine clearance <30ml/min
  • Receiving parenteral nutrition or enteral nutrition via feeding tube
  • receiving neo-adjuvant anti-cancer therapy
  • BMI >30 kg/m2
  • Use of appetite stimulants or anabolic/anti-catabolic agents (such as megestrol acetate, progestational agents, marijuana growth hormone, dronabinol, or other anabolic agent) within 30 days prior to study baseline
  • Concomitant steroid (>10mg/d prednisolone or equivalent) treatment for less than three months prior to inclusion (inhaled, optical or pulsed oral steroids (up to 10 days use) are permitted)
  • Concomitant long term (>1 week) nonsteroidal anti-inflammatory drugs (NSAID) 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 anti-coagulant treatment (e.g. warfarin or heparin)
  •  

Einschlusskriterien

     

  • Diagnosis of lung cancer, pancreatic cancer or cholangiocarcinoma where the diagnosis is based on histological, radiological or multidisciplinary team (MDT) evaluation
  • non-small cell lung cancer (stage III or IV), small cell lung cancer (extensive stage) or pancreatic adenocarcinoma (stage III or IV) or non-operable cholangiocarcinoma, due to commence first or second line anticancer treatment (defined as chemotherapy or chemo-radiotherapy or targeted therapy
  • staging CT within 4 weeks of commencement of anti-cancer therapy (in patients where staging CT is out-with this period, further CT scanning will be undertaken. PETCT's are also appropriate)
  • completed all other baseline assessments within one week prior to first course of anti-cancer 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
  •  

Studiendesign

  • Multizentrisch
  • Open Label
  • Phase IV
  • Zweiarmig

Intervention

Nutritional supplements and advice
Home-based self-assisted exercise program
Anti-inflammatory medication (ibuprofen)

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

Sponsor

  • Norwegian University of Science and Technology

Prüfzentrum 1

 

  • Klinik für Palliativmedizin
  • Universitätsklinik Bonn

Studienbüro

  • Klinik für Palliativmedizin
  • Universitätsklinik Bonn

Prüfer (Hauptprüfer im Zentrum)

Prof. Dr. med. Lukas Radbruch

Stellvertretender Prüfer

  • Dr. med. Henning Cuhls

Studienkontakt im Prüfzentrum

  • Prof. Dr. med. Lukas Radbruch

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