Trial Outcomes & Findings for Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain (NCT NCT00879775)
NCT ID: NCT00879775
Last Updated: 2011-03-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
two days
Results posted on
2011-03-29
Participant Flow
42 participants were screened. 1 did not meet criteria.
Participant milestones
| Measure |
Caffeine
Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
|
Placebo
Intravenous injections of 100ml of normal saline over 1 hour
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Caffeine
Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
|
Placebo
Intravenous injections of 100ml of normal saline over 1 hour
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain
Baseline characteristics by cohort
| Measure |
Caffeine
n=20 Participants
Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
|
Placebo
n=21 Participants
Intravenous injections of 100ml of normal saline over 1 hour
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63.40 years
STANDARD_DEVIATION 11.76 • n=99 Participants
|
67.83 years
STANDARD_DEVIATION 9.76 • n=107 Participants
|
65.67 years
STANDARD_DEVIATION 10.88 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Region of Enrollment
Korea, Republic of
|
20 participants
n=99 Participants
|
21 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Symptom score
Pain
|
3.25 scores
STANDARD_DEVIATION 1.06 • n=99 Participants
|
3.52 scores
STANDARD_DEVIATION 1.12 • n=107 Participants
|
3.39 scores
STANDARD_DEVIATION 1.09 • n=206 Participants
|
|
Symptom score
Drowsiness
|
4.05 scores
STANDARD_DEVIATION 1.57 • n=99 Participants
|
4.24 scores
STANDARD_DEVIATION 1.54 • n=107 Participants
|
4.15 scores
STANDARD_DEVIATION 1.54 • n=206 Participants
|
|
Symptom score
Nausea
|
2.20 scores
STANDARD_DEVIATION 1.19 • n=99 Participants
|
2.33 scores
STANDARD_DEVIATION 1.23 • n=107 Participants
|
2.27 scores
STANDARD_DEVIATION 1.21 • n=206 Participants
|
|
Symptom score
Sleep
|
4.20 scores
STANDARD_DEVIATION 1.96 • n=99 Participants
|
3.90 scores
STANDARD_DEVIATION 1.86 • n=107 Participants
|
4.05 scores
STANDARD_DEVIATION 1.90 • n=206 Participants
|
|
Symptom score
Sadness
|
4.55 scores
STANDARD_DEVIATION 1.39 • n=99 Participants
|
4.23 scores
STANDARD_DEVIATION 1.51 • n=107 Participants
|
4.39 scores
STANDARD_DEVIATION 1.45 • n=206 Participants
|
|
Symptom score
Fatigue
|
4.50 scores
STANDARD_DEVIATION 1.60 • n=99 Participants
|
4.47 scores
STANDARD_DEVIATION 1.56 • n=107 Participants
|
4.49 scores
STANDARD_DEVIATION 1.57 • n=206 Participants
|
|
Symptom score
Confusion
|
1.95 scores
STANDARD_DEVIATION 1.57 • n=99 Participants
|
2.52 scores
STANDARD_DEVIATION 1.50 • n=107 Participants
|
2.24 scores
STANDARD_DEVIATION 1.55 • n=206 Participants
|
|
Health-related quality of life
|
4.30 scores
STANDARD_DEVIATION 1.34 • n=99 Participants
|
4.19 scores
STANDARD_DEVIATION 1.12 • n=107 Participants
|
4.24 scores
STANDARD_DEVIATION 1.22 • n=206 Participants
|
|
Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean)
Daily living
|
5.00 scores
STANDARD_DEVIATION 2.12 • n=99 Participants
|
5.90 scores
STANDARD_DEVIATION 1.86 • n=107 Participants
|
5.46 scores
STANDARD_DEVIATION 2.03 • n=206 Participants
|
|
Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean)
Mode
|
5.90 scores
STANDARD_DEVIATION 1.51 • n=99 Participants
|
6.09 scores
STANDARD_DEVIATION 1.33 • n=107 Participants
|
6.00 scores
STANDARD_DEVIATION 1.41 • n=206 Participants
|
|
Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean)
Work
|
6.25 scores
STANDARD_DEVIATION 2.14 • n=99 Participants
|
6.90 scores
STANDARD_DEVIATION 1.64 • n=107 Participants
|
6.59 scores
STANDARD_DEVIATION 1.91 • n=206 Participants
|
|
Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean)
Interpersonal relationship
|
4.80 scores
STANDARD_DEVIATION 2.01 • n=99 Participants
|
5.09 scores
STANDARD_DEVIATION 1.54 • n=107 Participants
|
4.95 scores
STANDARD_DEVIATION 1.77 • n=206 Participants
|
|
Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean)
Gait ability
|
4.45 scores
STANDARD_DEVIATION 2.50 • n=99 Participants
|
5.61 scores
STANDARD_DEVIATION 1.93 • n=107 Participants
|
5.05 scores
STANDARD_DEVIATION 2.28 • n=206 Participants
|
|
Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean)
Life enjoyment
|
6.70 scores
STANDARD_DEVIATION 1.97 • n=99 Participants
|
7.66 scores
STANDARD_DEVIATION 1.55 • n=107 Participants
|
7.20 scores
STANDARD_DEVIATION 1.82 • n=206 Participants
|
PRIMARY outcome
Timeframe: two daysPopulation: intention to treat
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.
Outcome measures
| Measure |
Caffeine
n=18 Symptoms
Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
|
Placebo
n=20 Symptoms
Intravenous injections of 100ml of normal saline over 1 hour
|
|---|---|---|
|
Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids
Pain
|
2.22 scores
Standard Deviation 1.22
|
3.10 scores
Standard Deviation 1.17
|
|
Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids
Drowsiness
|
2.83 scores
Standard Deviation 1.92
|
3.05 scores
Standard Deviation 1.57
|
|
Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids
Confusion
|
1.89 scores
Standard Deviation 1.68
|
2.20 scores
Standard Deviation 1.36
|
|
Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids
Nausea
|
2.28 scores
Standard Deviation 1.41
|
1.80 scores
Standard Deviation 0.77
|
PRIMARY outcome
Timeframe: two daysScores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of sleep disturbance.
Outcome measures
| Measure |
Caffeine
n=18 Symptoms
Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
|
Placebo
n=20 Symptoms
Intravenous injections of 100ml of normal saline over 1 hour
|
|---|---|---|
|
Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids
|
3.53 scores
Standard Deviation 1.81
|
3.80 scores
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: two daysPopulation: intention to treat
Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of fatigue.
Outcome measures
| Measure |
Caffeine
n=18 Symptoms
Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
|
Placebo
n=20 Symptoms
Intravenous injections of 100ml of normal saline over 1 hour
|
|---|---|---|
|
Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10
|
3.61 scores
Standard Deviation 1.88
|
3.55 scores
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: two daysPopulation: intention to treat
Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a better health-related quality of life.
Outcome measures
| Measure |
Caffeine
n=18 Symptoms
Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
|
Placebo
n=20 Symptoms
Intravenous injections of 100ml of normal saline over 1 hour
|
|---|---|---|
|
Health-related Quality of Life
|
4.83 scores
Standard Deviation 1.30
|
4.45 scores
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: two daysPopulation: intention to treat
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.
Outcome measures
| Measure |
Caffeine
n=18 Symptoms
Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
|
Placebo
n=20 Symptoms
Intravenous injections of 100ml of normal saline over 1 hour
|
|---|---|---|
|
Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)
Daily living
|
5.17 scores
Standard Deviation 2.07
|
5.95 scores
Standard Deviation 1.82
|
|
Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)
Mood
|
5.61 scores
Standard Deviation 1.69
|
5.60 scores
Standard Deviation 1.54
|
|
Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)
Work
|
5.56 scores
Standard Deviation 1.85
|
6.75 scores
Standard Deviation 1.55
|
|
Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)
Interpersonal relationship
|
4.61 scores
Standard Deviation 1.79
|
4.65 scores
Standard Deviation 1.69
|
|
Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)
Gait ability
|
4.39 scores
Standard Deviation 2.36
|
5.50 scores
Standard Deviation 2.12
|
Adverse Events
Caffeine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Caffeine
n=18 participants at risk
Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
|
Placebo
n=20 participants at risk
Intravenous injections of 100ml of normal saline over 1 hour
|
|---|---|---|
|
Vascular disorders
Blood pressure elevation
|
0.00%
0/18
|
10.0%
2/20 • Number of events 2
|
Additional Information
Sang-Yeon Suh, M.D.,Ph.D
Department of Family Medicine, Dongguk University Ilsan Hospital, Republic of Korea
Phone: 0082-031-961-7490
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place