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Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy (MENAC)

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ClinicalTrials.gov Identifier: NCT02330926
Recruitment Status : Recruiting
First Posted : January 5, 2015
Last Update Posted : January 15, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:

Cancer cachexia is a multi-factorial syndrome defined by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment.

There is an urgency for improving management, but there is no consensus on the optimal treatment for cancer cachexia. Several single therapies for cancer cachexia have been examined in clinical trials, with disappointing overall results. As multiple factors are responsible for the development of cachexia, it has been argued that optimal cachexia interventions should target all components: multimodal therapy for a multimodal problem.

The overall aim of this study is to early prevent the development of cachexia rather than treatment late in the disease trajectory. From a patient perspective a short term effect will be to improve physical and psychological function, to reduce symptom burden and to improve survival. In other words live a longer and better life during and after chemotherapy. Direct effects of the cachexia intervention are expected to be reduction of weight and muscle loss, and improved physical activity and quality of life.


Condition or disease Intervention/treatment Phase
Cachexia Neoplasms Other: standard care Other: nutritional supplements and advice Other: home-based self-assisted exercise program Drug: Ibuprofen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomised, Open-label Trial of a Multimodal Intervention (Exercise, Nutrition and Antiinflammatory Medication) Plus Standard Care Versus Standard Care Alone to Prevent/Attenuate Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
Actual Study Start Date : April 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ibuprofen

Arm Intervention/treatment
Experimental: multimodal intervention
standard care plus multimodal intervention consisting of nutritional supplements and advice, home-based self-assisted exercise program, and anti-inflammatory medication (ibuprofen)
Other: standard care
Other: nutritional supplements and advice
Other: home-based self-assisted exercise program
Drug: Ibuprofen
Active Comparator: standard care
standard palliative care
Other: standard care



Primary Outcome Measures :
  1. change in body weight [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. change in muscle mass [ Time Frame: 6 weeks ]
  2. change in physical activity [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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), pancreatic adenocarcinoma (stage III or IV), due to commence first or second line anticancer treatment (defined as chemotherapy, chemo-radiotherapy, targeted therapy or immunotherapy)
  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330926


Contacts
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Contact: Trude R Balstad, PhD trude.r.balstad@ntnu.no
Contact: Tora S Solheim, MD PhD tora.l.skeidsvoll@ntnu.no

Locations
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Canada
CA4 Brampton Civic Hospital Recruiting
Brampton, Canada
Contact: Parneet Cheema, MD PhD       parneet.cheema@williamoslerhs.ca   
Cross Cancer Insitute Recruiting
Edmonton, Canada
Contact: Meri-Jo Thompson       methompson@toh.ca   
Principal Investigator: Quincy Chu, MD         
Jewish General Hospital Active, not recruiting
Montréal, Canada
Ottawa Regional Cancer Centre Recruiting
Ottawa, Canada
Contact: Meri-Jo Thompson       methompson@toh.ca   
Principal Investigator: Thimothy Asmis, MD         
Germany
Universitätsklinikum Bonn Recruiting
Bonn, Germany
Contact: Uta Wolber       Uta.Wolber@ukbonn.de   
Principal Investigator: Lukas Radbruch, MD         
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Asta Bye, PhD       asta.bye@hioa.no   
Principal Investigator: Nina Aass, MD, Prof         
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Trude R Balstad, PhD       trude.r.balstad@ntnu.no   
Contact: Inger Storaker, M.Sc.       inger.storaker@ntnu.no   
Principal Investigator: Tora S Solheim, MD, PhD         
Switzerland
Tumor Zentrum Active, not recruiting
Aarau, Switzerland
Cantonal Hospital Active, not recruiting
St. Gallen, Switzerland
United Kingdom
Llandough Hospital Recruiting
Cardiff, United Kingdom
Contact: Jackie Madden       menac@soton.ac.uk   
Contact: Natalie Hutchings       menac@soton.ac.uk   
Principal Investigator: Anthony Byrne, MD         
Edinburgh Cancer Centre Recruiting
Edinburgh, United Kingdom
Contact: Jackie Madden       menac@ac.soton.uk   
Contact: Natalie Hutchings       menac@ac.soton.uk   
Principal Investigator: Barry Laird, MD, PhD         
Queen Margaret Hospital Recruiting
Fife, United Kingdom
Contact: Jacke Madden       menac@ac.soton.uk   
Contact: Natalie Hutchings       menac@ac.soton.uk   
Principal Investigator: Joanna Bowden         
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom
Contact: Jackie Madden       menac@soton.ac.uk   
Contact: Natalie Hutchings       menac@soton.ac.uk   
Principal Investigator: Janet Graham         
Guys and St Thomas Recruiting
London, United Kingdom
Contact: Jackie Madden       menac@ac.soton.uk   
Contact: Natalie Hutchings       menac@soton.ac.uk   
Principal Investigator: Nick Gough, MD         
Sponsors and Collaborators
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
Investigators
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Study Director: Stein Kaasa, MD PhD European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, NTNU, Trondheim, Norway
Study Director: Marie Fallon, MD PhD Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK

Publications:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02330926     History of Changes
Other Study ID Numbers: MENAC-2013-05
2013-002282-19 ( EudraCT Number )
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Combined modality treatment
Diet therapy
Exercise therapy
Ibuprofen
Dietary supplements

Additional relevant MeSH terms:
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Cachexia
Wasting Syndrome
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action