Application of adenosine-5-triphosphate infusions in palliative home care
| ISRCTN | ISRCTN97280223 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97280223 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University Maastricht (The Netherlands) |
| Funders | University Maastricht (The Netherlands), Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands), Stichting NFK (The Netherlands) |
- 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
Scientific
University Maastricht
Department of Epidemiology
P.O. Box 616
Maastricht
6200 MD
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-labelled, randomised controlled trial with two parallel groups |
| Secondary study design | Randomised controlled trial |
| Scientific title | Application of adenosine-5-triphosphate infusions in palliative home care |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | Adenosine-5-triphosphate (ATP) |
| Primary outcome measure(s) |
1. Quality of life |
| Key secondary outcome measure(s) |
1. Appetite |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Maastricht
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
