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Completed

NCT Number: NCT00565188

Application of 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.

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Key information

Conditions

Cancer Neoplasms Palliative Care Quality of Life Survival

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Catharina Hospital Eindhoven, Eindhoven, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adenosine 5'-triphosphate

Drug

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

Primary outcomes

  1. Survival Physical restriction Fatigue Quality of life

    Time frame: 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

    Time frame: 0-8 weeks

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Application of Adenosine 5'-Triphosphate (ATP) Infusions in Palliative Home Care

Important dates

Study start
2002
Study completion
2006
First posted
Nov 29, 2007
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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