Application of ATP Infusions in Palliative Home Care

Phase 3

Completed

• Conditions: Cancer; Palliative Care; Survival; Quality of Life
• Interventions: Drug: Adenosine 5'-triphosphate

• Registration Number: NCT00565188
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study Completion: 2006-10
• Status Verified: 2007-11
• Study First Submitted: 2007-11-28
• Study First Submitted QC: 2007-11-28
• Study First Posted: 2007-11-29
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	Adenosine 5'-triphosphate	-

Primary Outcome Measures

Name	Time	Method
Survival Physical restriction Fatigue Quality of life	0-8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Maxima Medical Center; 🇳🇱 Eindhoven, Netherlands

Atrium MC; 🇳🇱 Heerlen, Netherlands

Maastricht University Hospital; 🇳🇱 Maastricht, Netherlands

Catharina Hospital Eindhoven; 🇳🇱 Eindhoven, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands