Condition category
Cancer
Date applied
14/09/2006
Date assigned
10/11/2006
Last edited
19/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pieter C Dagnelie

ORCID ID

Contact details

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

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

http://www.unimaas.nl

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

  1. 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.

Additional files

Editorial Notes