NCT02330926

Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy

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 Advanced Cancer Patients Undergoing Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cachexia
• Neoplasms

Interventions

Type	Name	Description
OTHER	standard care	Routine oncology and palliative care
DIETARY_SUPPLEMENT	nutritional supplements and advice	n-3 PUFA enriched supplements, dietary advice
BEHAVIORAL	home-based self-assisted exercise program	Strength and aerobic
DRUG	Ibuprofen	400mgx3

Timeline

• Start date: 2015-04-01
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2015-01-05
• Last updated: 2025-08-29

Locations

17 sites across 6 countries: United States, Canada, Germany, Norway, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study