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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002282-19 | EudraCT Number |
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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| Oslo University Hospital | OTHER |
| Cantonal Hospital of St. Gallen | OTHER |
| Ottawa Regional Cancer Centre |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multimodal intervention | Experimental | standard care plus multimodal intervention consisting of nutritional supplements and advice, home-based self-assisted exercise program, and anti-inflammatory medication (ibuprofen) |
|
| standard care | Active Comparator | standard palliative care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard care | Other | Routine oncology and palliative care |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in body weight | body weight (Kg) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in muscle mass | CT L3 cross sectional area | 6 weeks |
| change in physical activity | ActivPAL step count | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | CA 90048 | United States | ||
| CA4 Brampton Civic Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29440149 | Background | 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. | |
| 34528401 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2022 | May 19, 2022 |
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| 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 |
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| nutritional supplements and advice | Dietary Supplement | n-3 PUFA enriched supplements, dietary advice |
|
| home-based self-assisted exercise program | Behavioral | Strength and aerobic |
|
| Ibuprofen | Drug | 400mgx3 |
|
| 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 |
| 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. |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D002100 | Cachexia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D019587 | Dietary Supplements |
| D003376 | Counseling |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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