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

November 28, 2007
November 28, 2007
March 2002
Not Provided
Survival Physical restriction Fatigue Quality of life [ Time Frame: 0-8 weeks ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Application of ATP Infusions in Palliative Home Care
Application of Adenosine 5'-Triphosphate (ATP) Infusions in Palliative Home Care

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Palliative Care
  • Survival
  • Quality of Life
Drug: Adenosine 5'-triphosphate
Weekly ATP infusions (in total 8 infusions) during 8 - 12 hours in a maximum dose of 50 mcg/kg.min
  • Experimental: I
    Intervention: Drug: Adenosine 5'-triphosphate
  • No Intervention: C

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00565188
MEC 01-092.3, ZonMW 1135.0010
Yes
Not Provided
Maastricht University
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: P.C. Dagnelie, PhD Maastricht University - Department of Epidemiology
Maastricht University Medical Center
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP