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NCT Number: NCT00879775

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

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.

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Key information

Conditions

Cancer Confusion Fatigue Neoplasms Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Health Insurance Corporation Ilsan Hospital, Goyang-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Caffeine

Drug

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

Other names: Caffeine sodium benzoate

normal saline

Drug

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

Other names: 0.9% saline

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

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

    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 fatigue.

  2. Health-related Quality of Life

    Time frame: 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.

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

    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 impact of symptom burden to daily life.

Sponsors and collaborators

Lead sponsor

Korea Research Foundation

Other

Collaborators

  • Korea University Guro Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 10, 2009
Registry last updated
Mar 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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