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

Sandra Beijer,Erik Van Rossum,Cor Spreeuwenberg,Pierre S Hupperets,Marieke Van Den Beuken,Ron A Winkens,Ben E Van Den Borne,Pieter C Dagnelie,Alexander De Graeff,Lisette Ars

doi:10.1186/1471-2458-7-4

Abstract

BackgroundPalliative 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/DesignThe 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.DiscussionFrom 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.

Highlights

Palliative care in cancer aims at alleviating the suffering of patients
A previous randomized clinical trial in 58 patients with advanced non-small-cell lung cancer (NSCLC) showed that 10 intravenous 30-hour adenosine 5'-triphosphate (ATP) infusions every 2 to 4 weeks in a clinical setting had a favourable effect on fatigue, appetite, body weight, muscle strength, functional status and quality of life [5]
Considering the relatively mild character of ATP therapy, application of ATP infusions in palliative home care might be a promising and relatively simple treatment to improve the quality of life and functional status of patients with advanced cancer

Summary

Discussion

From April 2002 through October 2006, a total of 100 patients have been randomized: 10 patients in 2002, 5 in 2003, 22 in 2004, 40 in 2005, and 23 in 2006. The study was closed on October 31 2006. 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. We hope this study will demonstrate that ATP infusions leads to a reduction of frequently reported complaints in terminally ill cancer patients, for which no effective treatment is yet available. We hope to show that ATP-infusions can be administered safely in a home care

Background

Methods/Design

Findings

Courtens AM