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NCT02330926 · ClinicalTrials.gov registry record · Phase 3
Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
A Phase 3 study of Neoplasms and Cachexia, sponsored by Norwegian University of Science and Technology.
- Completed
- Registry status
- Phase 3
- Development phase
- 221
- Enrollment target
- 17
- Study locations
NCT02330926: Completed Phase 3 study of Neoplasms and Cachexia, sponsored by Norwegian University of Science and Technology.
NCT02330926 is a Phase 3 study of Neoplasms and Cachexia that has completed, run by Norwegian University of Science and Technology. The registered enrollment target is 221 participants, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (86% lower). The trial reports 17 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02330926, a Phase 3 study of Neoplasms and Cachexia, has completed, sponsored by Norwegian University of Science and Technology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 221 participants
- Enrollment target
- 17
- Study locations
Study 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.
Primary Outcome
body weight (Kg)
Interventions
- DRUG Ibuprofen
- OTHER standard care
- DIETARY_SUPPLEMENT nutritional supplements and advice
- BEHAVIORAL home-based self-assisted exercise program
Study Locations (17)
Other
- CA4 Brampton Civic Hospital - Brampton
- Cross Cancer Insitute - Edmonton
- Jewish General Hospital - Montreal
- Ottawa Regional Cancer Centre - Ottawa
- Universitätsklinikum Bonn - Bonn
- Oslo University Hospital - Oslo
- St Olavs Hospital - Trondheim
- Tumor Zentrum - Aarau
- Cantonal Hospital - Sankt Gallen
- Llandough Hospital - Cardiff
- Edinburgh Cancer Centre - Edinburgh
- Beatson West of Scotland Cancer Centre - Glasgow
- Chelsea and Westminister Hospital NHS - London
- Guys and St Thomas - London
California
- Cedars-Sinai Medical Center - Los Angeles
Falkirk
- NHS Forth Valley - Larbert
Fife
- Queen Margaret Hospital - Dunfermline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2015-04 |
| Est. Completion | 2023-04 |
| Phase | Phase 3 |
What the finished NCT02330926 record still lists
NCT02330926 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Ibuprofen is the first listed.
NCT02330926 lists 17 locations in 4 states (Other, California, Falkirk).
Frequently Asked Questions
What is clinical trial NCT02330926 about?
NCT02330926 is a clinical study titled "Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy". 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 the...
What is the current status of trial NCT02330926?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 221 participants. The study started on 2015-04. Estimated completion is 2023-04.
What conditions does trial NCT02330926 study?
This clinical trial studies the following conditions: Neoplasms, Cachexia.
What interventions are being tested in trial NCT02330926?
The interventions under investigation include: Ibuprofen (DRUG), standard care (OTHER), nutritional supplements and advice (DIETARY_SUPPLEMENT), home-based self-assisted exercise program (BEHAVIORAL).
Who is sponsoring clinical trial NCT02330926?
This trial is sponsored by Norwegian University of Science and Technology, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02330926 being conducted?
This trial has 17 study locations across California, Falkirk, Fife. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02330926's enrollment target sits among peer trials
221 45th of 158 higher than 114 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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