Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain
Efficacy of Caffeine as an Adjuvant to Opioid Therapy in Cancer Pain: a Randomized, Double-blind, Placebo-controlled Trial
3 other identifiers
interventional
41
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 cancer
Started Apr 2009
Shorter than P25 for phase_2 cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 9, 2009
CompletedFirst Posted
Study publicly available on registry
April 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
March 29, 2011
CompletedMarch 29, 2011
September 1, 2009
3 months
April 9, 2009
January 11, 2011
March 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids
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.
two days
Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids
Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of sleep disturbance.
two days
Secondary Outcomes (3)
Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10
two days
Health-related Quality of Life
two days
Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)
two days
Study Arms (2)
Caffeine
EXPERIMENTALIntravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
Placebo
PLACEBO COMPARATORIntravenous injections of 100ml of normal saline over 1 hour
Interventions
Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days.
Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korea Research Foundationlead
- Korea University Guro Hospitalcollaborator
Study Sites (2)
National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Korea University Guro Hospital
Seoul, South Korea
Related Publications (3)
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. doi: 10.1016/s0885-3924(01)00249-4.
PMID: 11369156BACKGROUNDManfredi PL, Gonzales GR. Symptomatic uses of caffeine in patients with cancer. J Palliat Care. 2003 Spring;19(1):63-5. No abstract available.
PMID: 12710118BACKGROUNDBruera E, Watanabe S. Psychostimulants as adjuvant analgesics. J Pain Symptom Manage. 1994 Aug;9(6):412-5. doi: 10.1016/0885-3924(94)90179-1.
PMID: 7963794BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sang-Yeon Suh, M.D.,Ph.D
- Organization
- Department of Family Medicine, Dongguk University Ilsan Hospital, Republic of Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Sang-Yeon Suh, M.D.,Ph.D
DongGuk University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 9, 2009
First Posted
April 10, 2009
Study Start
April 1, 2009
Primary Completion
July 1, 2009
Study Completion
September 1, 2009
Last Updated
March 29, 2011
Results First Posted
March 29, 2011
Record last verified: 2009-09