Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
1. Does Adenosine-5-Triphosphate (ATP) administration to terminal cancer patients improve the quality of life, in terms of functional status and health complaints such as fatigue, exhaustion and weight loss?
2. Does ATP infusion relieve family caregiver burden and reduce use of professional health care services?
3. Is application of ATP infusions in a home care setting feasible for terminal cancer patients?
Ethics approval
Medical Ethical Committee of the Academic Hospital Maastricht and Maastricht University, date of approval: 4 July 2001 (ref. number: METC 01-092).
Study design
Open-labelled, randomised controlled trial with two parallel groups
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Cancer patients in the end stage of disease
Intervention
Control group:
Usual care and additional home visits by a dietician
Intervention group:
Usual care, additional home visits by a dietician and ATP infusions (eight to 12 hour infusion every week during the study period of eight weeks)
Intervention type
Drug
Phase
Not Specified
Drug names
Adenosine-5-triphosphate (ATP)
Primary outcome measures
1. Quality of life
2. Fatigue
3. Physical restriction
Secondary outcome measures
1. Appetite
2. Nutritional intake
3. Anthropometric measurements
4. Muscle strength
5. Caregiver burden
Overall trial start date
01/01/2002
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Cancer patients for whom no systemic treatment is available, or medical treatment options are restricted to palliative/supportive care
2. Life expectancy of less than six months
3. The diagnosis cancer must have been confirmed histologically or cytologically
4. World Health Organisation (WHO) performance status classification in cancer one or two
5. Presence of at least one of the following complaints:
a. fatigue
b. weight loss over 5% over last six months
c. anorexia
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
80-100 patients (depending on the drop-out rate)
Participant exclusion criteria
1. Symptomatic angina pectoris
2. Symptomatic heart failure
3. Any form of AtrioVentricular (AV)-block (assessed by Electrocardiogram [ECG])
4. Cognitive dysfunction or other disease obstructing an adequate follow up
5. Life expectancy of less than four weeks
6. Concurrent palliative chemotherapy
Recruitment start date
01/01/2002
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Maastricht
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
University Maastricht (The Netherlands)
Sponsor details
P.O. Box 616
Maastricht
6200 MD
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University Maastricht (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Funder name
Stichting NFK (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Study protocol: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17210069
Publication citations
-
Study protocol
Beijer S, van Rossum E, Hupperets PS, Spreeuwenberg C, van den Beuken M, Winkens RA, Ars L, van den Borne BE, de Graeff A, Dagnelie PC, Application of adenosine 5'-triphosphate (ATP) infusions in palliative home care: design of a randomized clinical trial., BMC Public Health, 2007, 7, 4, doi: 10.1186/1471-2458-7-4.