Application of ATP Infusions in Palliative Home Care

October 24, 2016 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Eindhoven, Netherlands, 5602 ZA
        • Catharina Hospital Eindhoven
      • Eindhoven, Netherlands, 5600 PD
        • Maxima Medical Center
      • Heerlen, Netherlands, 6419 PC
        • Atrium MC
      • Maastricht, Netherlands, 6202 AZ
        • Maastricht University Hospital
      • Utrecht, Netherlands, 3508 GA
        • University Medical Center Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I
Drug: Adenosine 5'-triphosphate
Weekly ATP infusions (in total 8 infusions) during 8 - 12 hours in a maximum dose of 50 mcg/kg.min
No Intervention: C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival Physical restriction Fatigue Quality of life
Time Frame: 0-8 weeks
0-8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
0-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: P.C. Dagnelie, PhD, Maastricht University - Department of Epidemiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

November 28, 2007

First Submitted That Met QC Criteria

November 28, 2007

First Posted (Estimate)

November 29, 2007

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 01-092.3
  • ZonMW 1135.0010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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