Application of ATP Infusions in Palliative Home Care

NCT ID: NCT00565188

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Palliative Care Survival Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I

Group Type EXPERIMENTAL

Adenosine 5'-triphosphate

Intervention Type DRUG

Weekly ATP infusions (in total 8 infusions) during 8 - 12 hours in a maximum dose of 50 mcg/kg.min

C

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adenosine 5'-triphosphate

Weekly ATP infusions (in total 8 infusions) during 8 - 12 hours in a maximum dose of 50 mcg/kg.min

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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P.C. Dagnelie, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University - Department of Epidemiology

Locations

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Maxima Medical Center

Eindhoven, , Netherlands

Site Status

Catharina Hospital Eindhoven

Eindhoven, , Netherlands

Site Status

Atrium MC

Heerlen, , Netherlands

Site Status

Maastricht University Hospital

Maastricht, , Netherlands

Site Status

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 10675381 (View on PubMed)

Agteresch 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.

Reference Type BACKGROUND
PMID: 11786563 (View on PubMed)

Agteresch 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.

Reference Type BACKGROUND
PMID: 14501386 (View on PubMed)

Other Identifiers

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ZonMW 1135.0010

Identifier Type: -

Identifier Source: secondary_id

MEC 01-092.3

Identifier Type: -

Identifier Source: org_study_id

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