Application of adenosine-5-triphosphate infusions in palliative home care

ISRCTN ISRCTN97280223
DOI https://doi.org/10.1186/ISRCTN97280223
Submission date
14/09/2006
Registration date
10/11/2006
Last edited
06/11/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Pieter C Dagnelie
Scientific

University Maastricht
Department of Epidemiology
P.O. Box 616
Maastricht
6200 MD
Netherlands

Study information

Study designOpen-labelled, randomised controlled trial with two parallel groups
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific titleApplication of adenosine-5-triphosphate infusions in palliative home care
Study objectives1. 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(s)Medical Ethical Committee of the Academic Hospital Maastricht and Maastricht University, date of approval: 4 July 2001 (ref. number: METC 01-092).
Health condition(s) or problem(s) studiedCancer patients in the end stage of disease
InterventionControl 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Adenosine-5-triphosphate (ATP)
Primary outcome measure1. Quality of life
2. Fatigue
3. Physical restriction
Secondary outcome measures1. Appetite
2. Nutritional intake
3. Anthropometric measurements
4. Muscle strength
5. Caregiver burden
Overall study start date01/01/2002
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants80-100 patients (depending on the drop-out rate)
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2002
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Maastricht
Maastricht
6200 MD
Netherlands

Sponsor information

University Maastricht (The Netherlands)
University/education

P.O. Box 616
Maastricht
6200 MD
Netherlands

Website http://www.unimaas.nl
ROR logo "ROR" https://ror.org/02jz4aj89

Funders

Funder type

University/education

University Maastricht (The Netherlands)

No information available

Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Private sector organisation / Other non-profit organizations
Alternative name(s)
Netherlands Organisation for Health Research and Development
Location
Netherlands
Stichting NFK (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article Study protocol: 08/01/2007 Yes No

Editorial Notes

06/11/2019: Internal review.