NCT00565188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 cancer

Timeline
Completed

Started Mar 2002

Typical duration for phase_3 cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
Last Updated

October 25, 2016

Status Verified

November 1, 2007

First QC Date

November 28, 2007

Last Update Submit

October 24, 2016

Conditions

CancerPalliative CareSurvivalQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Survival Physical restriction Fatigue Quality of life

    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

    0-8 weeks

Study Arms (2)

I

EXPERIMENTAL
Drug: Adenosine 5'-triphosphate

C

NO INTERVENTION

Interventions

Adenosine 5'-triphosphateDRUG

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

I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Maxima Medical Center

Eindhoven, 5600 PD, Netherlands

Location

Catharina Hospital Eindhoven

Eindhoven, 5602 ZA, Netherlands

Location

Atrium MC

Heerlen, 6419 PC, Netherlands

Location

Maastricht University Hospital

Maastricht, 6202 AZ, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3508 GA, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 10675381BACKGROUND

  • 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.

    PMID: 11786563BACKGROUND

  • 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.

    PMID: 14501386BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Adenosine Triphosphate

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • P.C. Dagnelie, PhD

    Maastricht University - Department of Epidemiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 29, 2007

Study Start

March 1, 2002

Study Completion

October 1, 2006

Last Updated

October 25, 2016

Record last verified: 2007-11

Locations

NL(5)