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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Caffeine as an Adjuvant to Opioid Therapy in Cancer Pain: a Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Cancer, Pain

Intervention / Treatment
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* Drug: Caffeine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caffeine<br>Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour | Drug: Caffeine<br>* Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days.<br>* Other names: Caffeine sodium benzoate;|
| Placebo Comparator: Placebo<br>Intravenous injections of 100ml of normal saline over 1 hour | Drug: Normal saline<br>* Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days<br>* Other names: 0.9% saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10 | Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of fatigue. | two days | 
| Health-related Quality of Life | Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a better health-related quality of life. | two days | 
| Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) | 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. | two days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Cancer patients, Caffeine, Adjuvant analgesics, Sedation, Confusion, Quality of life, Fatigue