Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
NCT ID: NCT02330926
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
221 participants
INTERVENTIONAL
2015-04-30
2023-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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multimodal intervention
standard care plus multimodal intervention consisting of nutritional supplements and advice, home-based self-assisted exercise program, and anti-inflammatory medication (ibuprofen)
standard care
Routine oncology and palliative care
nutritional supplements and advice
n-3 PUFA enriched supplements, dietary advice
home-based self-assisted exercise program
Strength and aerobic
Ibuprofen
400mgx3
standard care
standard palliative care
standard care
Routine oncology and palliative care
Interventions
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standard care
Routine oncology and palliative care
nutritional supplements and advice
n-3 PUFA enriched supplements, dietary advice
home-based self-assisted exercise program
Strength and aerobic
Ibuprofen
400mgx3
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
Oslo University Hospital
OTHER
Cantonal Hospital of St. Gallen
OTHER
Ottawa Regional Cancer Centre
OTHER
Jewish General Hospital
OTHER
Cross Cancer Institute
OTHER
The Beatson West of Scotland Cancer Centre
UNKNOWN
Queen Margaret Hospital, Dunfermline
OTHER
Cancer Research UK Edinburgh Centre
UNKNOWN
Malteser Krankenhaus Seliger Gerhardt
UNKNOWN
Tumor Biology Center Freiburg
UNKNOWN
Tumor Zentrum Aarau
UNKNOWN
Chelsea and Westminster NHS Foundation Trust
OTHER
Cedars-Sinai Medical Center
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
NHS Forth Valley
OTHER_GOV
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Stein Kaasa, MD PhD
Role: STUDY_DIRECTOR
European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, NTNU, Trondheim, Norway
Marie Fallon, MD PhD
Role: STUDY_DIRECTOR
Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
CA4 Brampton Civic Hospital
Brampton, , Canada
Cross Cancer Insitute
Edmonton, , Canada
Jewish General Hospital
Montreal, , Canada
Ottawa Regional Cancer Centre
Ottawa, , Canada
Universitätsklinikum Bonn
Bonn, , Germany
Oslo University Hospital
Oslo, , Norway
St Olavs Hospital
Trondheim, , Norway
Tumor Zentrum
Aarau, , Switzerland
Cantonal Hospital
Sankt Gallen, , Switzerland
NHS Forth Valley
Larbert, Falkirk, United Kingdom
Queen Margaret Hospital
Dunfermline, Fife, United Kingdom
Llandough Hospital
Cardiff, , United Kingdom
Edinburgh Cancer Centre
Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Chelsea and Westminister Hospital NHS
London, , United Kingdom
Guys and St Thomas
London, , United Kingdom
Countries
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References
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Solheim TS, Laird BJA, Balstad TR, Bye A, Stene G, Baracos V, Strasser F, Griffiths G, Maddocks M, Fallon M, Kaasa S, Fearon K. Cancer cachexia: rationale for the MENAC (Multimodal-Exercise, Nutrition and Anti-inflammatory medication for Cachexia) trial. BMJ Support Palliat Care. 2018 Sep;8(3):258-265. doi: 10.1136/bmjspcare-2017-001440. Epub 2018 Feb 9.
Naito T. Challenges in enhancing physical performance in thoracic cancer cachexia. Thorac Cancer. 2021 Oct;12(20):2633-2634. doi: 10.1111/1759-7714.14154. Epub 2021 Sep 15. No abstract available.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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2013-002282-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MENAC-2013-05
Identifier Type: -
Identifier Source: org_study_id
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