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Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain

Primary Purpose

Cancer, Pain

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Caffeine

Normal saline

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Pain, Cancer patients, Caffeine, Adjuvant analgesics, Sedation, Confusion, Quality of life, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

National Health Insurance Corporation Ilsan Hospital
Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Caffeine

Placebo

Arm Description

Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour

Intravenous injections of 100ml of normal saline over 1 hour

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT00879775

First Posted

April 9, 2009

Last Updated

March 3, 2011

Sponsor

Korea Research Foundation

Collaborators

Korea University Guro Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00879775

Brief Title

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

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Korea Research Foundation

Collaborators

Korea University Guro Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Pain

Keywords

Pain, Cancer patients, Caffeine, Adjuvant analgesics, Sedation, Confusion, Quality of life, Fatigue

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Caffeine

Arm Type

Experimental

Arm Description

Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intravenous injections of 100ml of normal saline over 1 hour

Intervention Type

Drug

Intervention Name(s)

Caffeine

Other Intervention Name(s)

Caffeine sodium benzoate

Intervention Description

Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days.

Intervention Type

Drug

Intervention Name(s)

Normal saline

Other Intervention Name(s)

0.9% saline

Intervention Description

Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days

Primary Outcome Measure Information:

Title

Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids

Description

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

Title

Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids

Description

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

Secondary Outcome Measure Information:

Title

Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10

Description

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

Title

Health-related Quality of Life

Description

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

Title

Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang-Yeon Suh, M.D.,Ph.D

Organizational Affiliation

DongGuk University

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Health Insurance Corporation Ilsan Hospital

City

Goyang-si

State/Province

Gyeonggi-do

Country

Korea, Republic of

Facility Name

Korea University Guro Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

11369156

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.

Results Reference

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PubMed Identifier

12710118

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.

Results Reference

background

PubMed Identifier

7963794

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.

Results Reference

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Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain

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