Letzte Aktualisierung: 05.04.2023
Pankreaskarzinom (Bauchspeicheldrüsenkrebs)
MENAC
Studieninformationen
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.
Ziele
Primäres Prüfziel
Body weight – difference between intervention and control group at study endpoint (T2)
Sekundäre Prüfziele für die Behandlungsarme:
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
Design
Phase
Zentren
Datenerhebung
Interventionsgruppen
Verblindung
Erkrankung
Diagnose
Diagnosenbeschreibung
Diagnosis of advanced lung cancer, pancreatic cancer or cholangiocarcinoma.
Mutation
Stadium
Patienten
Alter
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
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)
Therapie
Intervention
Nutritional supplements and advice
Home-based self-assisted exercise program
Anti-inflammatory medication (ibuprofen)
Substanz
Sonstiges
Prüfplancode | MENAC-2013-05 |
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EudraCT | 2013-002282-19 |
Clinicaltrials.gov | NCT02330926 |
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ISRCTN | - |
DRKS | - |
Zuständige Gesamtstudie
Norwegian University of Science and Technology
Leiter der klinischen Prüfung (LKP)Prof. Dr. med. Kaasa Stein
Studiengruppen/-zentrale
Kontakt Klinische Studien
CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490
CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036
CIO Köln: Uniklinik Köln, +49 (0) 221 478-0
CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)