Clinical trial NCT00565188: Application of ATP Infusions in Palliative Home Care
Official title: Application of Adenosine 5'-Triphosphate (ATP) Infusions in Palliative Home Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Palliative Care
Survival
Quality of Life
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2007-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival Physical restriction Fatigue Quality of life
timeFrame: 0-8 weeks
Secondary outcomes:
measure: 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
timeFrame: 0-8 weeks
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Maxima Medical Center
city: Eindhoven
country: Netherlands
facility: Catharina Hospital Eindhoven
city: Heerlen
country: Netherlands
facility: Atrium MC
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Maastricht University - Department of Epidemiology
name: P.C. Dagnelie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1093/jnci/92.4.321.
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. doi: 10.1200/JCO.2002.20.2.371.
citation: 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.