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Efficacy of Caffeine as an Adjuvant to Opioid Therapy in Cancer Pain: a Randomized, Double-blind, Placebo-controlled Trial


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer, Pain

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Trial Information

Efficacy of Caffeine as an Adjuvant to Opioid Therapy in Cancer Pain: a Randomized, Double-blind, Placebo-controlled Trial


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome 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.

Outcome Time Frame:

two days

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

DongGuk University

Authority:

Korea: Food and Drug Administration

Study ID:

E00058

NCT ID:

NCT00879775

Start Date:

April 2009

Completion Date:

September 2009

Related Keywords:

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

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