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| ID | Type | Description | Link |
|---|---|---|---|
| GR0857-006 | Other Identifier | Korea University Guro Hospital | |
| SuYeon2009-08 | Other Identifier | National Health Insurance Corporation Ilsan Hospital |
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| Name | Class |
|---|---|
| Korea University Guro Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeine | Experimental | Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour |
|
| Placebo | Placebo Comparator | Intravenous injections of 100ml of normal saline over 1 hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine | Drug | Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Yeon Suh, M.D.,Ph.D | DongGuk University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Health Insurance Corporation Ilsan Hospital | Goyang-si | Gyeonggi-do | South Korea | |||
| Korea University Guro Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11369156 | Background | 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. | |
| 12710118 | Background | Manfredi PL, Gonzales GR. Symptomatic uses of caffeine in patients with cancer. J Palliat Care. 2003 Spring;19(1):63-5. No abstract available. |
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42 participants were screened. 1 did not meet criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Caffeine | Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour |
| FG001 | Placebo | Intravenous injections of 100ml of normal saline over 1 hour |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caffeine | Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour |
| BG001 | Placebo | Intravenous injections of 100ml of normal saline over 1 hour |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | intention to treat | Posted | Mean | Standard Deviation | scores | two days | Symptoms | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caffeine | Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood pressure elevation | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sang-Yeon Suh, M.D.,Ph.D | Department of Family Medicine, Dongguk University Ilsan Hospital, Republic of Korea | 0082-031-961-7490 | fmmodel@gmail.com |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010146 | Pain |
| D003221 | Confusion |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| C025741 | caffeine, sodium benzoate drug combination |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Normal saline | Drug | Intravenous injections of 100ml of normal saline over 1 hour, once a day, for 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.
| 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 |
| Seoul |
| South Korea |
| 7963794 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Symptom score | Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of symptoms. | Mean | Standard Deviation | scores |
|
| 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. | Mean | Standard Deviation | scores |
|
| 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. | Mean | Standard Deviation | scores |
|
|
|
| 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. | intention to treat | Posted | Mean | Standard Deviation | scores | two days | Symptoms | Participants |
|
|
|
| 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. | intention to treat | Posted | Mean | Standard Deviation | scores | two days | Symptoms | Participants |
|
|
|
| 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. | intention to treat | Posted | Mean | Standard Deviation | scores | two days | Symptoms | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | scores | two days | Symptoms | Participants |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Placebo | Intravenous injections of 100ml of normal saline over 1 hour | 0 | 20 | 2 | 20 |
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| D009422 | Nervous System Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Work |
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| Interpersonal relationship |
|
| Gait ability |
|