Clinical Trial: Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Advance
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.
Detailed Summary:
Sponsor: Norwegian University of Science and Technology
Current Primary Outcome: body weight change [ Time Frame: 6 weeks ]
Original Primary Outcome: body weight change [ Time Frame: 12 weeks ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Norwegian University of Science and Technology
Dates:
Date Received: December 31, 2014
Date Started: April 2015
Date Completion: August 2019
Last Updated: January 4, 2017
Last Verified: January 2017
