Application of ATP Infusions in Palliative Home Care - Full Text View

Sponsors and Collaborators:	Maastricht University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00565188

Purpose

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, quality of life, and survival. Based on these promising results, the present study was designed 1. To evaluate whether the beneficial effects of ATP administration observed in patients with advanced lung cancer would also be present in pre-terminal cancer patients of different tumour types, and 2. To test the feasibility of application of ATP infusions in a home care setting.

Condition	Intervention	Phase
Cancer Palliative Care Survival Quality of Life	Drug: Adenosine 5'-triphosphate	Phase III

MedlinePlus related topics: Cancer Palliative Care

Drug Information available for: Adenosine Adenosine triphosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Application of Adenosine 5'-Triphosphate (ATP) Infusions in Palliative Home Care

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

Survival Physical restriction Fatigue Quality of life [ Time Frame: 0-8 weeks ]

Secondary Outcome Measures:

Appetite Nutritional intake Body height Body weight Triceps skin fold thickness Mid-upper arm circumference Strength of elbow flexor and knee extensor muscles Handgrip strength Process evaluation [ Time Frame: 0-8 weeks ]

Enrollment:	100
Study Start Date:	March 2002
Study Completion Date:	October 2006

Arms	Assigned Interventions
I: Experimental	Drug: Adenosine 5'-triphosphate Weekly ATP infusions (in total 8 infusions) during 8 - 12 hours in a maximum dose of 50 mcg/kg.min
C: No Intervention

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

cytologically or histologically confirmed cancer
medical treatment options restricted to supportive care
a life expectancy < 6 months
World Health Organization (WHO) performance status 1 or 2
suffering from at least one of the following complaints: fatigue, weight loss > 5% over the last 6 months, or anorexia

Exclusion Criteria:

symptomatic angina pectoris
symptomatic heart failure
any form of atrioventricular (AV) block (assessed by electrocardiogram)
life expectancy < 4 weeks
concurrent palliative chemotherapy
cognitive dysfunction, and other diseases hampering adequate follow up

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565188

Locations

Netherlands
Maastricht University Hospital
Maastricht, Netherlands, 6202 AZ
Catharina Hospital Eindhoven
Eindhoven, Netherlands, 5602 ZA
University Medical Center Utrecht
Utrecht, Netherlands, 3508 GA
Maxima Medical Center
Eindhoven, Netherlands, 5600 PD
Atrium MC
Heerlen, Netherlands, 6419 PC

Sponsors and Collaborators

Maastricht University Medical Center

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

Principal Investigator:

P.C. Dagnelie, PhD

Maastricht University - Department of Epidemiology

More Information

Publications:

Agteresch HJ, Dagnelie PC, van der Gaast A, Stijnen T, Wilson JH. Randomized clinical trial of adenosine 5'-triphosphate in patients with advanced non-small-cell lung cancer. J Natl Cancer Inst. 2000 Feb 16;92(4):321-8.

Agteresch HJ, Rietveld T, Kerkhofs LG, van den Berg JW, Wilson JH, Dagnelie PC. Beneficial effects of adenosine triphosphate on nutritional status in advanced lung cancer patients: a randomized clinical trial. J Clin Oncol. 2002 Jan 15;20(2):371-8.

Agteresch HJ, Burgers SA, van der Gaast A, Wilson JH, Dagnelie PC. Randomized clinical trial of adenosine 5'-triphosphate on tumor growth and survival in advanced lung cancer patients. Anticancer Drugs. 2003 Sep;14(8):639-44.

Study ID Numbers:	MEC 01-092.3, ZonMW 1135.0010
Study First Received:	November 28, 2007
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00565188
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Quality of Life
Adenosine

Additional relevant MeSH terms:

Vasodilator Agents
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009