Cancer Clinical Trial
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Catharina Hospital Eindhoven | Eindhoven | |
Netherlands | Maxima Medical Center | Eindhoven | |
Netherlands | Atrium MC | Heerlen | |
Netherlands | Maastricht University Hospital | Maastricht | |
Netherlands | University Medical Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival Physical restriction Fatigue Quality of life | 0-8 weeks | ||
Secondary | 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 | 0-8 weeks |
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