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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022897-14 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Edinburgh | OTHER |
| Oslo University Hospital | OTHER |
| NHS Greater Glasgow and Clyde | OTHER |
| Copenhagen University Hospital at Herlev |
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A multicentre, open, randomized phase II study comparing a multimodal intervention (oral nutritional supplements, celecoxib and physical exercise) for cachexia versus standard cancer care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal intervention | Experimental |
| |
| Standard Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal intervention | Other | Nutritional supplements aimed at optimal energy balance and protein intake (2 cartons of ProSure per day), nutritional advice, home-based self-assisted exercise program and anti-inflammatory treatment (300 mg celecoxib) for 6 weeks. The aerobic exercise program is performed as self-administered daily walking sessions, aiming for a minimum of two sessions 30 minutes on a weekly basis. Other aerobic activities could be used instead of walking. The resistance exercise program should be performed 3 times weekly and lasts about 20 minutes. The program is targeting major muscle groups in the upper body and legs with use of weights. The intensity of the exercise and performance of the exercises are adapted to the individual patient's disease burden and physical performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of recruitment and retention | The aim of this study is to investigate the feasibility of the multimodal intervention for cancer cachexia by assessing; enrolment rate, compliance with study intervention, contamination-rate in the control group with respect to any of the interventions. | 12 weeks |
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Main eligibility criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stein Kaasa, MD, PhD | National Taiwan Normal University | Principal Investigator |
| Ken Fearon, MD, PhD | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital Ullevål | Oslo | Norway | ||||
| St Olavs Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28614627 | Result | Solheim TS, Laird BJA, Balstad TR, Stene GB, Bye A, Johns N, Pettersen CH, Fallon M, Fayers P, Fearon K, Kaasa S. A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer. J Cachexia Sarcopenia Muscle. 2017 Oct;8(5):778-788. doi: 10.1002/jcsm.12201. Epub 2017 Jun 14. | |
| 33585533 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OTHER |
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|
| Standard care | Other | Standard cancer care |
|
| Trondheim |
| Norway |
| University of Edinburgh | Edinburgh | United Kingdom |
| Balstad TR, Brunelli C, Pettersen CH, Schonberg SA, Skorpen F, Fallon M, Kaasa S, Bye A, Laird BJA, Stene GB, Solheim TS. Power Comparisons and Clinical Meaning of Outcome Measures in Assessing Treatment Effect in Cancer Cachexia: Secondary Analysis From a Randomized Pilot Multimodal Intervention Trial. Front Nutr. 2021 Jan 14;7:602775. doi: 10.3389/fnut.2020.602775. eCollection 2020. |
| 31816924 | Derived | Stene GB, Balstad TR, Leer ASM, Bye A, Kaasa S, Fallon M, Laird B, Maddocks M, Solheim TS. Deterioration in Muscle Mass and Physical Function Differs According to Weight Loss History in Cancer Cachexia. Cancers (Basel). 2019 Dec 3;11(12):1925. doi: 10.3390/cancers11121925. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |