CancerPhase 3NCT00565188
Application of ATP Infusions in Palliative Home Care
A Phase 3 study testing Adenosine 5'-triphosphate in people with Cancer and Palliative Care, run by Maastricht University Medical Center at 5 sites in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Palliative Care, Survival
- What is being tested?
- Adenosine 5'-triphosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesNetherlands
- Study dates
- Mar 2002to Oct 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Maxima Medical Center
Eindhoven, 5600 PD
Catharina Hospital Eindhoven
Eindhoven, 5602 ZA
Atrium MC
Heerlen, 6419 PC
Maastricht University Hospital
Maastricht, 6202 AZ
University Medical Center Utrecht
Utrecht, 3508 GA
About this study
Official title: 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.
- Conditions
- Cancer, Palliative Care, Survival, Quality of Life
- Being tested
- Adenosine 5'-triphosphate
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenosine 5'-triphosphateDrug
Weekly ATP infusions (in total 8 infusions) during 8 - 12 hours in a maximum dose of 50 mcg/kg.min
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Drug: Adenosine 5'-triphosphate |
| C | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Physical restriction Fatigue Quality of life
Measured: 0-8 weeks
Secondary outcomes (1)
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
Measured: 0-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startMar 2002
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- P.C. Dagnelie, PhD, Principal investigator, Maastricht University - Department of Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565188
- Sponsor's protocol ID
- MEC 01-092.3
- Other IDs
- ZonMW 1135.0010
- Status last verified
- Nov 2007
- First submitted
- 28 Nov 2007
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Agteresch HJ, Dagnelie PC, van der Gaast A, Stijnen T, Wilson JH. Randomized clinical trial of adenosine 5'-triphosphate in patients with advanced non-small-cell lung cancer. J Natl Cancer Inst. 2000 Feb 16;92(4):321-8. doi: 10.1093/jnci/92.4.321.
PubMed 10675381Agteresch HJ, Rietveld T, Kerkhofs LG, van den Berg JW, Wilson JH, Dagnelie PC. Beneficial effects of adenosine triphosphate on nutritional status in advanced lung cancer patients: a randomized clinical trial. J Clin Oncol. 2002 Jan 15;20(2):371-8. doi: 10.1200/JCO.2002.20.2.371.
PubMed 11786563Agteresch HJ, Burgers SA, van der Gaast A, Wilson JH, Dagnelie PC. Randomized clinical trial of adenosine 5'-triphosphate on tumor growth and survival in advanced lung cancer patients. Anticancer Drugs. 2003 Sep;14(8):639-44. doi: 10.1097/00001813-200309000-00009.
PubMed 14501386
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Adenosine 5'-Triphosphate (ATP) Infusions in Palliative Home Care
- ClinicalTrials.gov ID
- NCT00565188
- Acronym / sponsor ID
- MEC 01-092.3
- Conditions
- Cancer, Palliative Care, Survival, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Mar 2002
- Study completion
- Oct 2006 (actual)
- First posted
- 29 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: Adenosine 5'-triphosphate |
| C | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- symptomatic angina pectoris
- symptomatic heart failure
- any form of atrioventricular (AV) block (assessed by electrocardiogram)
- life expectancy < 4 weeks
- concurrent palliative chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adenosine 5'-triphosphateWeekly ATP infusions (in total 8 infusions) during 8 - 12 hours in a maximum dose of 50 mcg/kg.min | Drug | I |
Primary outcome
Survival Physical restriction Fatigue Quality of life
Time frame: 0-8 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Background: PubMed 10675381Agteresch HJ, Dagnelie PC, van der Gaast A, Stijnen T, Wilson JH. Randomized clinical trial of adenosine 5'-triphosphate in patients with advanced non-small-cell lung cancer. J Natl Cancer Inst. 2000 Feb 16;92(4):321-8. doi: 10.1093/jnci/92.4.321.
- Background: PubMed 11786563Agteresch HJ, Rietveld T, Kerkhofs LG, van den Berg JW, Wilson JH, Dagnelie PC. Beneficial effects of adenosine triphosphate on nutritional status in advanced lung cancer patients: a randomized clinical trial. J Clin Oncol. 2002 Jan 15;20(2):371-8. doi: 10.1200/JCO.2002.20.2.371.
- Background: PubMed 14501386Agteresch HJ, Burgers SA, van der Gaast A, Wilson JH, Dagnelie PC. Randomized clinical trial of adenosine 5'-triphosphate on tumor growth and survival in advanced lung cancer patients. Anticancer Drugs. 2003 Sep;14(8):639-44. doi: 10.1097/00001813-200309000-00009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P.C. Dagnelie, PhD principal investigator
Maastricht University - Department of Epidemiology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adenosine 5'-triphosphate in people with Cancer and Palliative Care, run by Maastricht University Medical Center at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Physical restriction Fatigue Quality of life (time frame: 0-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00565188, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.