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Application of ATP Infusions in Palliative Home Care

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00565188
First received: November 28, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Application of Adenosine 5'-Triphosphate (ATP) Infusions in Palliative Home Care

Resource links provided by NLM:

U.S. FDA Resources

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

  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
Catharina Hospital Eindhoven
Eindhoven, Netherlands, 5602 ZA
Maxima Medical Center
Eindhoven, Netherlands, 5600 PD
Atrium MC
Heerlen, Netherlands, 6419 PC
Maastricht University Hospital
Maastricht, Netherlands, 6202 AZ
University Medical Center Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
Maastricht University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: P.C. Dagnelie, PhD Maastricht University - Department of Epidemiology
  More Information

Publications:

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

Additional relevant MeSH terms:
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 16, 2013