Study protocol

Application of adenosine 5'-triphosphate (ATP) infusions in palliative home care: design of a randomized clinical trial

Sandra Beijer¹ , Erik van Rossum¹ , Pierre S Hupperets² , Cor Spreeuwenberg³ , Marieke van den Beuken⁴ , Ron A Winkens⁵ , Lisette Ars⁶ , Ben E van den Borne⁷ , Alexander de Graeff⁸ and Pieter C Dagnelie¹

¹Department of Epidemiology, Maastricht University, P.O. Box 616, 6200 MD Maastricht, The Netherlands

²Department of Internal Medicine/Oncology, University Hospital Maastricht, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands

³Department of Health Care Studies, Maastricht University, P.O. Box 616, 6200 MD Maastricht, The Netherlands

⁴Pain Management and Research Centre, University Hospital Maastricht, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands

⁵Department of Integrated Care, University Hospital Maastricht, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands

⁶Community Care Organisation, GroenekruisDomicura Maastricht and area, Mockstraat 1, 6226 CA Maastricht, The Netherlands

⁷Department of Pulmonology, Catharina Hospital Eindhoven, P.O. Box 1350, 5602 ZA Eindhoven, The Netherlands

⁸Department of Internal Medicine/Medical Oncology, University Medical Center Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands

author email corresponding author email

BMC Public Health 2007, 7:4doi:10.1186/1471-2458-7-4

Published:	8 January 2007

Abstract

Background

Palliative care in cancer aims at alleviating the suffering of patients. A previous study in patients with advanced non-small-cell lung cancer showed that adenosine 5'-triphosphate (ATP) infusions had a favourable effect on fatigue, appetite, body weight, muscle strength, functional status and quality of life. The present study was designed 1. To evaluate whether ATP has favourable effects in terminally ill cancer patients, 2. To evaluate whether ATP infusions may reduce family caregiver burden and reduce the use of professional health care services, and 3. To test the feasibility of application of ATP infusions in a home care setting.

Methods/Design

The study can be characterized as an open-labelled randomized controlled trial with two parallel groups. The intervention group received usual palliative care, two visits by an experienced dietician for advice, and regular ATP infusions over a period of 8 weeks. The control group received palliative care as usual and dietetic advice, but no ATP. This paper gives a description of the study design, selection of patients, interventions and outcome measures.

Discussion

From April 2002 through October 2006, a total of 100 patients have been randomized. Follow-up of patients will be completed in December 2006. At the time of writing, five patients are still in follow up. Of the 95 patients who have completed the study, 69 (73%) have completed four weeks of follow-up, and 53 (56%) have completed the full eight-week study period. The first results are expected in 2007.