CancerPhase 2NCT00879775
Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain
A Phase 2 study testing Caffeine and Normal saline in people with Cancer and Pain, run by Korea Research Foundation at 2 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Caffeine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Apr 2009to Sep 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Chronic glaucoma
- Cognitive impairment
- Progressive pain over 7 (by numeric rating scale)
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do
Korea University Guro Hospital
Seoul
About this study
Official title: Efficacy of Caffeine as an Adjuvant to Opioid Therapy in Cancer Pain: a Randomized, Double-blind, Placebo-controlled Trial
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.
Read the 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.
- Being tested
- Caffeine, Normal saline
- Keywords
- Pain, Cancer patients, Caffeine, Adjuvant analgesics, Sedation, Confusion, Quality of life, Fatigue
- Medical subject headings
- Neoplasms, Pain, Confusion, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Also called Caffeine sodium benzoate
Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days.
Normal salineDrug
Also called 0.9% saline
Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour Receives: Drug: Caffeine |
| Placebo | Placebo comparator | Intravenous injections of 100ml of normal saline over 1 hour Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: two days
Secondary outcomes (3)
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.
Measured: two days
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.
Measured: 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.
Measured: two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Guro Hospital
- Investigators
- Sang-Yeon Suh, M.D.,Ph.D, Principal investigator, DongGuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879775
- Sponsor's protocol ID
- E00058
- Other IDs
- GR0857-006, SuYeon2009-08
- Status last verified
- Sep 2009
- First submitted
- 9 Apr 2009
- Last updated
- 29 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 11369156Manfredi PL, Gonzales GR. Symptomatic uses of caffeine in patients with cancer. J Palliat Care. 2003 Spring;19(1):63-5. No abstract available.
PubMed 12710118Bruera 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.
PubMed 7963794
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Caffeine as an Adjuvant to Opioid Therapy in Cancer Pain: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00879775
- Acronym / sponsor ID
- E00058
- Keywords
- Pain, Cancer patients, Caffeine, Adjuvant analgesics, Sedation, Confusion, Quality of life, Fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Korea Research FoundationUniversity, hospital or other
- Collaborators
- Korea University Guro Hospital
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 10 Apr 2009 (estimated)
- Results
- Posted 29 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Drug: CaffeineIntravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour |
| Placebo | Placebo comparator | Drug: Normal salineIntravenous injections of 100ml of normal saline over 1 hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaffeineAlso: Caffeine sodium benzoateIntravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days. | Drug | Caffeine |
| Normal salineAlso: 0.9% salineIntravenous injections of 100ml of normal saline over 1 hour, once a day, for two days | Drug | Placebo |
Primary outcome
Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids
Time frame: 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
Time frame: 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.
3 secondary outcomes
Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10
Time frame: two days
Health-related Quality of Life
Time frame: two days
Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)
Time frame: two days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11369156Mercadante 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.
- Background: PubMed 12710118Manfredi PL, Gonzales GR. Symptomatic uses of caffeine in patients with cancer. J Palliat Care. 2003 Spring;19(1):63-5. No abstract available.
- Background: PubMed 7963794Bruera 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Yeon Suh, M.D.,Ph.D principal investigator
DongGuk University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caffeine and Normal saline in people with Cancer and Pain, run by Korea Research Foundation at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids (time frame: two days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00879775, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2011.