Phase 2 N=41 Randomized Quadruple-blind Supportive Care

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

Cancer · Pain

Bottom Line

View on ClinicalTrials.gov: NCT00879775 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2011

Primary outcome: Primary: Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids — 2.22; 3.10; 2.83; 3.05 scores

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Caffeine (Drug); Normal saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Korea Research Foundation
Primary completion: Jul 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids	2.22; 3.10; 2.83; 3.05; 1.89; 2.20	—
PRIMARY Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids	3.53; 3.80	—
SECONDARY Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10	3.61; 3.55	—
SECONDARY Health-related Quality of Life	4.83; 4.45	—
SECONDARY Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)	5.17; 5.95; 5.61; 5.60; 5.56; 6.75	—

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.

Eligibility 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00879775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.