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Sponsors and Collaborators: |
Maastricht University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development |
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Information provided by: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT00565188 |
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 |
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Cancer Palliative Care Survival Quality of Life |
Drug: Adenosine 5'-triphosphate |
Phase III |
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 |
Enrollment: | 100 |
Study Start Date: | March 2002 |
Study Completion Date: | October 2006 |
Arms | Assigned Interventions |
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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
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C: No Intervention |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | P.C. Dagnelie, PhD | Maastricht University - Department of Epidemiology |
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) |
Quality of Life Adenosine |
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 |