Application of ATP Infusions in Palliative Home Care

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565188
• Other study ID #: MEC 01-092.3
• Secondary ID: ZonMW 1135.0010
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2007
• Last updated: October 24, 2016
• Start date: March 2002
• Est. completion date: October 2006

Study information

• Verified date: November 2007
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2006
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Palliative Care
• Quality of Life
• Survival

Intervention

Drug:
• Adenosine 5'-triphosphate
Weekly ATP infusions (in total 8 infusions) during 8 - 12 hours in a maximum dose of 50 mcg/kg.min

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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

Outcome

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