Cancer, Pain
Conditions
Keywords
Pain, Cancer patients, Caffeine, Adjuvant analgesics, Sedation, Confusion, Quality of life, Fatigue
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.
Interventions
DRUGCaffeine
Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days.
DRUGNormal saline
Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days
Sponsors
Korea University Guro Hospital
Korea Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids | two days | 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. |
| Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids | two days | Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of sleep disturbance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10 | two days | Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of fatigue. |
| Health-related Quality of Life | two days | Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a better health-related quality of life. |
| Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) | two days | 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. |
Countries
South Korea
Participant flow
Recruitment details
42 participants were screened. 1 did not meet criteria.
Participants by arm
| Arm | Count |
|---|---|
| Caffeine Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour | 20 |
| Placebo Intravenous injections of 100ml of normal saline over 1 hour | 21 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Caffeine | Total | Placebo |
|---|---|---|---|
| Age Continuous | 63.40 years STANDARD_DEVIATION 11.76 | 65.67 years STANDARD_DEVIATION 10.88 | 67.83 years STANDARD_DEVIATION 9.76 |
| Health-related quality of life | 4.30 scores STANDARD_DEVIATION 1.34 | 4.24 scores STANDARD_DEVIATION 1.22 | 4.19 scores STANDARD_DEVIATION 1.12 |
| Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean) Daily living | 5.00 scores STANDARD_DEVIATION 2.12 | 5.46 scores STANDARD_DEVIATION 2.03 | 5.90 scores STANDARD_DEVIATION 1.86 |
| Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean) Gait ability | 4.45 scores STANDARD_DEVIATION 2.5 | 5.05 scores STANDARD_DEVIATION 2.28 | 5.61 scores STANDARD_DEVIATION 1.93 |
| Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean) Interpersonal relationship | 4.80 scores STANDARD_DEVIATION 2.01 | 4.95 scores STANDARD_DEVIATION 1.77 | 5.09 scores STANDARD_DEVIATION 1.54 |
| Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean) Life enjoyment | 6.70 scores STANDARD_DEVIATION 1.97 | 7.20 scores STANDARD_DEVIATION 1.82 | 7.66 scores STANDARD_DEVIATION 1.55 |
| Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean) Mode | 5.90 scores STANDARD_DEVIATION 1.51 | 6.00 scores STANDARD_DEVIATION 1.41 | 6.09 scores STANDARD_DEVIATION 1.33 |
| Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean) Work | 6.25 scores STANDARD_DEVIATION 2.14 | 6.59 scores STANDARD_DEVIATION 1.91 | 6.90 scores STANDARD_DEVIATION 1.64 |
| Region of Enrollment Korea, Republic of | 20 participants | 41 participants | 21 participants |
| Sex: Female, Male Female | 9 Participants | 21 Participants | 12 Participants |
| Sex: Female, Male Male | 11 Participants | 20 Participants | 9 Participants |
| Symptom score Confusion | 1.95 scores STANDARD_DEVIATION 1.57 | 2.24 scores STANDARD_DEVIATION 1.55 | 2.52 scores STANDARD_DEVIATION 1.5 |
| Symptom score Drowsiness | 4.05 scores STANDARD_DEVIATION 1.57 | 4.15 scores STANDARD_DEVIATION 1.54 | 4.24 scores STANDARD_DEVIATION 1.54 |
| Symptom score Fatigue | 4.50 scores STANDARD_DEVIATION 1.6 | 4.49 scores STANDARD_DEVIATION 1.57 | 4.47 scores STANDARD_DEVIATION 1.56 |
| Symptom score Nausea | 2.20 scores STANDARD_DEVIATION 1.19 | 2.27 scores STANDARD_DEVIATION 1.21 | 2.33 scores STANDARD_DEVIATION 1.23 |
| Symptom score Pain | 3.25 scores STANDARD_DEVIATION 1.06 | 3.39 scores STANDARD_DEVIATION 1.09 | 3.52 scores STANDARD_DEVIATION 1.12 |
| Symptom score Sadness | 4.55 scores STANDARD_DEVIATION 1.39 | 4.39 scores STANDARD_DEVIATION 1.45 | 4.23 scores STANDARD_DEVIATION 1.51 |
| Symptom score Sleep | 4.20 scores STANDARD_DEVIATION 1.96 | 4.05 scores STANDARD_DEVIATION 1.9 | 3.90 scores STANDARD_DEVIATION 1.86 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 2 / 20 |
| serious Total, serious adverse events | 0 / 18 | 0 / 20 |
Outcome results
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.
Time frame: two days
Population: intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caffeine | 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 |
| Caffeine | 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 |
| Caffeine | 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 |
| Caffeine | 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 |
| Placebo | Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids | Nausea | 1.80 scores | Standard Deviation 0.77 |
| Placebo | Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids | Pain | 3.10 scores | Standard Deviation 1.17 |
| Placebo | Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids | Confusion | 2.20 scores | Standard Deviation 1.36 |
| Placebo | Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids | Drowsiness | 3.05 scores | Standard Deviation 1.57 |
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.
Time frame: two days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caffeine | Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids | 3.53 scores | Standard Deviation 1.81 |
| Placebo | Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids | 3.80 scores | Standard Deviation 1.79 |
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.
Time frame: two days
Population: intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caffeine | Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10 | 3.61 scores | Standard Deviation 1.88 |
| Placebo | Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10 | 3.55 scores | Standard Deviation 1.5 |
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.
Time frame: two days
Population: intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caffeine | Health-related Quality of Life | 4.83 scores | Standard Deviation 1.3 |
| Placebo | Health-related Quality of Life | 4.45 scores | Standard Deviation 0.89 |
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.
Time frame: two days
Population: intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caffeine | Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) | Mood | 5.61 scores | Standard Deviation 1.69 |
| Caffeine | Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) | Interpersonal relationship | 4.61 scores | Standard Deviation 1.79 |
| Caffeine | Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) | Work | 5.56 scores | Standard Deviation 1.85 |
| Caffeine | Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) | Gait ability | 4.39 scores | Standard Deviation 2.36 |
| Caffeine | Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) | Daily living | 5.17 scores | Standard Deviation 2.07 |
| Placebo | Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) | Gait ability | 5.50 scores | Standard Deviation 2.12 |
| Placebo | Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) | Daily living | 5.95 scores | Standard Deviation 1.82 |
| Placebo | Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) | Mood | 5.60 scores | Standard Deviation 1.54 |
| Placebo | Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) | Work | 6.75 scores | Standard Deviation 1.55 |
| Placebo | Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean) | Interpersonal relationship | 4.65 scores | Standard Deviation 1.69 |