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

Korea Research Foundation

Status and phase: Completed; Phase 2

Conditions: Cancer; Pain

Treatments: Drug: Caffeine; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00879775

E00058

SuYeon2009-08 (Other Identifier)

GR0857-006 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups, including a placebo group

Caffeine

Experimental group

Description:

Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour

Treatment:

Drug: Caffeine

Placebo

Placebo Comparator group

Description:

Intravenous injections of 100ml of normal saline over 1 hour

Treatment:

Drug: Normal saline