Cancer pain
Conditions
Interventions
Two groups:Fentanyl Transdermal patch for 28 days versus Oral morphine
Sponsors
Nil
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. With pain secondary to cancer; 2. Must have a histologically confirmed malignancy that has either recurred after potentially curative therapy or is not amenable to curative therapy at presentation; 3. Must have pain caused by the presence of malignant disease; 4. Must require analgesic according to Step III of the WHO analgesic ladder; 5. Have cancer-related pain with average 24hour pain score > 4; 6. Aged >= 18 years; 7. Estimated life expectancy of at least 3 months; 8. Ability to communicate effectively with the study personnel about the nature of their pain and be able to complete their diary; 9. Ability to read and sign informed consent; 10. Women of childbearing age must take adequate contraception.
Exclusion criteria
Exclusion criteria: A patient will be excluded from the study if he/she has any of the following: 1. A history of opioid allergy; 2. A history of narcotic abuse prior to the diagnosis of cancer; 3. Active skin disease that precludes the use of transdermal patches; 4. Clinically relevant CO2 retention (e.g. COPD); 5. Abnormal laboratory values*: 6. Serum bilirubin level > 34 umol/L (>2.0 mg/ dL); 7. Serum creatine >177 umol/L (> 2.0 mg/dL); 8. Any co-existing neuropathic pain; 9. Receiving regular treatment with an strong opioid for their pain before entering the study; 10. Received radiation therapy or changes in hormonal and/or chemotherapy within 7 days prior to study entry; 11. Participated in an investigational drug trial 30 days prior to the selection; 12. Any co-existing medical condition that is likely to interfere with the study process; 13. Palliative Performance Scale (PPS) of less than 70.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The dose of TTS-fentanyl: The investigator will record the dose of TTS-fentanyl used by the patient and the date of change.;Pain Score Assessment: The severity of pain will be evaluated by average pain score in 24 hours using Numerical Rating Scale (NRS). The patient will complete his/her diary daily.;Overall Satisfaction in Pain Control: The patient will make a global assessment of his/her pain treatment using a 4-point scale (excellent, good, fair, poor) at the start of the study (visit 2), visit 3 and at the end of the study (day 28, visit 4) with investigator.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nausea, Vomiting and Sedation: The severity will be evaluated using a 4-point scale: absent, mild, moderate, severe and recorded in the patient’s diary. The frequency of vomiting and his concomitant medication will be recorded on the diary. It will also be evaluated by investigator at each study visits.;Gastrointestinal disturbances;The investigator will assess the effects on the gastrointestinal track by evaluating the number, the consistency and the passage of stools, the presence of abdominal pain and bloating and the use of laxatives at each visit. Evaluation of the use of the patches.;The patient will be asked to rate the convenience of the patches on a 4-point scale (excellent, good, fair, poor) at visit 3 and 4.;The patient must be instructed to report any early removal of patch (<3days) immediately to the investigator.;An overall evaluation on patient’s preference will also be made at visit 4 or end of the trial.;General condition.;The investigator will record the patients’ general condition using the Palliative Performance Scale at the start of the study (visit 2) and further at all study visits.; | — |
Countries
China
Contacts
Public ContactDr Tsang Ho Sze
Outcome results
None listed