Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain

This study has been completed.
Sponsor:
Collaborator:
Korea University Guro Hospital
Information provided by:
Korea Research Foundation
ClinicalTrials.gov Identifier:
NCT00879775
First received: April 9, 2009
Last updated: March 3, 2011
Last verified: September 2009
  Purpose

Pain is a most common symptom and it has a high impact on quality of life in cancer patients. Many cancer patients have received opioid therapy, but also many of them have suffered from side effects of opioids. Drowsiness and confusion are common side effects of opioids. Caffeine is a well known psychostimulant,and it is widely used as an analgesics. Thus, the investigators aimed to prove the efficacy of intravenous caffeine administration as an adjuvant analgesics to opioids. At the same time, the investigators tried to find that the side effects of opioids could be ameliorated by caffeine.


Condition Intervention Phase
Cancer
Pain
Drug: Caffeine
Drug: Normal saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy of Caffeine as an Adjuvant to Opioid Therapy in Cancer Pain: a Randomized, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Korea Research Foundation:

Primary Outcome Measures:
  • Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids [ Time Frame: two days ] [ Designated as safety issue: No ]
    Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; higher scores represent higher levels of pain, and possible side effects (drowsiness, confusion, nausea) of opioids.

  • Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids [ Time Frame: two days ] [ Designated as safety issue: No ]
    Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of sleep disturbance.


Secondary Outcome Measures:
  • Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10 [ Time Frame: two days ] [ Designated as safety issue: No ]
    Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of fatigue.

  • Health-related Quality of Life [ Time Frame: two days ] [ Designated as safety issue: No ]
    Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a better health-related quality of life.

  • Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) [ Time Frame: two days ] [ Designated as safety issue: No ]
    Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of impact of symptom burden to daily life.


Enrollment: 41
Study Start Date: April 2009
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caffeine
Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
Drug: Caffeine
Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days.
Other Name: Caffeine sodium benzoate
Placebo Comparator: Placebo
Intravenous injections of 100ml of normal saline over 1 hour
Drug: Normal saline
Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days
Other Name: 0.9% saline

Detailed Description:

Previous studies on cancer pain lacked assessment of quality of life. And most of previous studies on cancer pain did not give attention to symptoms accompanied with pain. We include such variables as outcome measures, and aimed to evaluate the efficacy and the safety of intravenous caffeine in advanced cancer inpatients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced (Stage IV) cancer inpatients
  • Adults aged over 18 years
  • Patients who have received opioid therapy and whose pain scales are under 6 (by numeric rating scale)
  • Patients who do not take caffeine beverage 48 hours before study period
  • Volunteers who provided written informed consent

Exclusion Criteria:

  • Sensitivity (palpitation,headache,irritability,insomnia) to caffeine
  • Uncontrolled hypertension and/or heart disease
  • Liver failure (alanine aminotransferase >= 100 IU/L)
  • Kidney failure (serum creatinine >= 2.0 mg/dL)
  • Patients taken theophylline
  • Gastroesophageal reflux disease
  • Chronic glaucoma
  • Cognitive impairment
  • Progressive pain over 7 (by numeric rating scale)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879775

Locations
Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea Research Foundation
Korea University Guro Hospital
Investigators
Principal Investigator: Sang-Yeon Suh, M.D.,Ph.D DongGuk University
  More Information

Publications:
Responsible Party: Sang-Yeon Suh, Dongguk University Ilsan Hospitial
ClinicalTrials.gov Identifier: NCT00879775     History of Changes
Other Study ID Numbers: E00058, GR0857-006, SuYeon2009-08
Study First Received: April 9, 2009
Results First Received: January 11, 2011
Last Updated: March 3, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea Research Foundation:
Pain
Cancer patients
Caffeine
Adjuvant analgesics
Sedation
Confusion
Quality of life
Fatigue

Additional relevant MeSH terms:
Caffeine
Caffeine, sodium benzoate drug combination
Sodium Benzoate
Benzoates
Analgesics, Opioid
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Antifungal Agents
Anti-Infective Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Depressants
Antimutagenic Agents
Protective Agents
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on July 29, 2014