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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879775
• Other study ID #: E00058
• Secondary ID: GR0857-006SuYeon
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2009
• Last updated: March 3, 2011
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Korea Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

Drug:
• Caffeine
Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days.
• Normal saline
Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days

Locations

Country	Name	City	State
Korea, Republic of	National Health Insurance Corporation Ilsan Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea Research Foundation	Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Bruera E, Watanabe S. Psychostimulants as adjuvant analgesics. J Pain Symptom Manage. 1994 Aug;9(6):412-5. Review. — View Citation

Manfredi PL, Gonzales GR. Symptomatic uses of caffeine in patients with cancer. J Palliat Care. 2003 Spring;19(1):63-5. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No