Symptoms and General Pathology

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Fatigue

Cancer Pain

Pain

Confusion

Neurologic Manifestations

Quality of Life

Central Nervous System Stimulants

All Drugs and Chemicals

Analgesics

Central Nervous System Depressants

Anti-Infective Agents

Other Dietary Supplements

Caffeine

Analgesics, Opioid

Sodium Benzoate

Caffeine, sodium benzoate drug combination

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Neurotransmitter Agents

Clotrimazole

Miconazole

Antifungal Agents

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

Intravenous injections of 100ml of normal saline over 1 hour

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

Normal saline

Sang-Yeon Suh, M.D.,Ph.D

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.

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.

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

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.

Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of sleep disturbance.

Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of fatigue.

Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a better health-related quality of life.

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.

Korea University Guro Hospital

Korea Research Foundation

Sang-Yeon Suh

Placebo

Total

Age Continuous

Sex: Female, Male

Korea, Republic of

Region of Enrollment

Drowsiness

Nausea

Sleep

Sadness

Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of symptoms.

Symptom score

Health-related quality of life

Daily living

Mode

Work

Interpersonal relationship

Gait ability

Life enjoyment

Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean)

Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids

Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10

Health-related Quality of Life

Mood

Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)

Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain	NCT00879775	Cancer Pain	Caffeine Normal saline	18 Years -	Korea Research Foundation
Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain	NCT00879775	Cancer Pain	Caffeine Normal saline	18 Years -	Korea Research Foundation

Spots Global Cancer Trial Database for adjuvant analgesics