Clinical trial NCT00879775: Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain
Official title: Efficacy of Caffeine as an Adjuvant to Opioid Therapy in Cancer Pain: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Pain
Keywords: Pain
Cancer patients
Caffeine
Adjuvant analgesics
Sedation
Confusion
Quality of life
Fatigue
Lead sponsor: Korea Research Foundation
Sponsor class: OTHER
Collaborators: name: Korea University Guro Hospital
First posted: 2009-04-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

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)

Primary outcomes:
measure: Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids
timeFrame: two days
measure: Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids
timeFrame: two days
Secondary outcomes:
measure: Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10
timeFrame: two days
measure: Health-related Quality of Life
timeFrame: two days
measure: Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)
timeFrame: two days
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: DongGuk University
name: Sang-Yeon Suh, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0885-3924(01)00249-4.
citation: Manfredi PL, Gonzales GR. Symptomatic uses of caffeine in patients with cancer. J Palliat Care. 2003 Spring;19(1):63-5. No abstract available.
citation: Bruera E, Watanabe S. Psychostimulants as adjuvant analgesics. J Pain Symptom Manage. 1994 Aug;9(6):412-5. doi: 10.1016/0885-3924(94)90179-1.