Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy

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

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

Sponsors & Collaborators

• St. Olavs Hospital

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Cantonal Hospital of St. Gallen

  collaborator OTHER

• Ottawa Regional Cancer Centre

  collaborator OTHER

• Jewish General Hospital

  collaborator OTHER

• Cross Cancer Institute

  collaborator OTHER

• The Beatson West of Scotland Cancer Centre

  collaborator UNKNOWN

• Queen Margaret Hospital, Dunfermline

  collaborator OTHER

• Cancer Research UK Edinburgh Centre

  collaborator UNKNOWN

• Malteser Krankenhaus Seliger Gerhardt

  collaborator UNKNOWN

• Tumor Biology Center Freiburg

  collaborator UNKNOWN

• Tumor Zentrum Aarau

  collaborator UNKNOWN

• Chelsea and Westminster NHS Foundation Trust

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• NHS Forth Valley

  collaborator OTHER_GOV

• Norwegian University of Science and Technology

  lead OTHER

Principal Investigators

• Stein Kaasa, MD PhD · European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, NTNU, Trondheim, Norway

• Marie Fallon, MD PhD · Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2023-04-30

Completion

2023-04-30

FDA Drug

Yes

Countries

• United States
• Canada
• Germany
• Norway
• Switzerland
• United Kingdom

Study Locations