Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat cancer pain in patients who have not been treated with a strong opioid.

Detailed Description
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This is a multicenter, prospective, open-label (all people know the identity of the intervention) and observational study. Patients selected for the proposed study are patients complaining of cancer pain who visit or are hospitalized at the research centers during the study, who are not being treated with strong continuous opioid (narcotic medication used against the pain), and who require cancer pain control with hydromorphone, at the investigator's discretion. The study will evaluate the changes in pain relief, level of sleep deprivation, and the patients' quality of life before and after administration of hydromorphone.

Official Title
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Clinical Usefulness and Quality of Life of OROS Hydromorphone in Strong Opioid-Naïve Cancer Pain Patients; Multicenter, Prospective, Open-Label and Observational Study

Conditions
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Pain

Intervention / Treatment
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* Drug: Hydromorphone HCI OROS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients who complain of cancer pain and who require administration of hydromorphone HCl - Patients who can follow the requirements of the overall study, including completion of filling out the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, at the investigator's discretion - Signed informed consent Exclusion Criteria: - Patients who received strong continuous narcotic analgesics (eg morphine, fentanyl, oxycodone, hydromorphone) within 4 weeks prior to administration of the study drug - Patients who have a medical history of receiving drugs in the past or currently, or of drug abuse - Patients who did not agree to conduct the approved methods for contraception during the study - Patients who have sustained injuries in physical functions or diseases which may cause abnormalities in absorbing the study drug, excessive accumulation and metabolic or elimination disorder - Patients who are receiving Monoamine Oxidase Inhibitors (MAO) inhibitors or who are within 2 weeks from discontinuation - Patients who need to be excluded based on precautions in the user manual of the study drug, notice and contradictions, at the investigator's discretion

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hydromorphone HCI OROS<br> | Drug: Hydromorphone HCI OROS<br>* type= exact number, unit= mg, number=4, form= tablet, route= oral use. One tablet administered once a day. The dose may be increased if the level of pain increases or if the pain-killing effect is insufficient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of patients with % PID (Pain Intensity Difference) over 30% of patients from the first evaluation date until the third evaluation date, following the administration of hydromorphone HCI to cancer pain patients |  | Baseline and at approximately Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Karnofsky Performance Rating Scale (KPRS) | The KPRS measures the physical functions of cancer patients, and indicates the feasibility of daily life by 10% units from 0% (death) to 100% (normal status in which patients can do activities to the level before disease without limitations). | Baseline, and at approximately Days 29 and 57 | 
| Change in pain relief (%) | How much pain was relieved by the pain therapy or medication for the last 24 hours, using %: 0%= nothing reduced and 100%= completely reduced. | Baseline, and at approximately Days 29 and 57 | 
| Frequency of awakening | Check whether patients experienced awakening during sleep caused by pain for the last 1 week or not, and measure the frequency (1 = once, 2 = twice, 3 = 3 times, 4 = more than 4 times, 5 = not woken, 6 = never slept). | Baseline, and at approximately Days 29 and 57 | 
| Level of sleep inconvenience | Measure the level of sleep inconvenience that patients experienced due to pain for the last 1 week using the Numeric Rating Scale (NRS); 0 = not causing inconvenience, 10 = completely causing inconvenience. | Baseline, and at approximately Days 29 and 57 | 
| Satisfaction with sleep | Indicate the overall satisfaction with sleep by improving sleep disturbance caused by pain for the last 1 week using the Numeric Rating Scale (0 never satisfied on the left end; 10 very satisfied on the right end). | Baseline, and at approximately Days 29 and 57 | 
| Quality of life assessment measured by the EORTC QLQ-C15 PAL | The EORTC (European Organization for Research and Treatment of Cancer) QLQ-C15 (Quality of Life Questionnaire Core 15) is a commonly used questionnaire to assess the quality of life of cancer patients taking paliative medicine. This questionnaire consists of questions measuring physical, role, emotional, cognitive and social functions, and answers are given based on a 4-point scale, from 1 (not at all) to 4 (very much so). | Baseline, and at approximately Days 29 and 57 | 
| Investigator's Global Assessment | The investigator's global assessment is used to assess how effective the study drug was for the patients after administration of the study drug since the last evaluation date. It is measured by the investigator from the investigator's point of view as 1 = not effective, 2 = normal l, 3 = effective, 4 very effective, and 5 = extremely effective. | At approximately Days 29 and 57 | 
| Patient's Global Assessment | The patient's global assessment is used to assess how effective the study drug was for the patients after administration of the study drug since the last evaluation date. It is measured by the patient from the patient's point of view as 1 = not effective, 2 = normal, 3 = effective, 4 = very effective, and 5 = extremely effective. | At approximately Days 29 and 57 | 
| CGI-I (Clinical Global Impression - Improvement) | Evaluate how much patients have improved compared with the conditions of patients at baseline, from 1 (very much improved) to 7 (greatly deteriorated). | At approximately Days 29 and 57 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Cancer pain, Hydromorphone, Hydromorphone OROS, Narcotic analgesics, Opioid-naive