Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain - Full Text View

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:

MedlinePlus related topics: Caffeine Cancer Fatigue

Drug Information available for: Sodium benzoate Potassium benzoate

U.S. FDA Resources

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

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:

Mercadante S, Serretta R, Casuccio A. Effects of caffeine as an adjuvant to morphine in advanced cancer patients. A randomized, double-blind, placebo-controlled, crossover study. J Pain Symptom Manage. 2001 May;21(5):369-72.

Manfredi PL, Gonzales GR. Symptomatic uses of caffeine in patients with cancer. J Palliat Care. 2003 Spring;19(1):63-5. Review. No abstract available.

Bruera E, Watanabe S. Psychostimulants as adjuvant analgesics. J Pain Symptom Manage. 1994 Aug;9(6):412-5. Review.

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:

Adjuvants, Immunologic
Caffeine
Caffeine, sodium benzoate drug combination
Sodium Benzoate
Benzoates
Analgesics, Opioid
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Stimulants
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 May 16, 2013