Shin, S.H., Lee, H.S., Kim, Y.S., Choi, Y.J., Kim, S.G., Kwon, H.C., . . . Chung, J.S. (2014). Clinical usefulness of hydromorphone-OROS in improving sleep disturbances in Korean cancer patients: A multicenter, prospective, open-label study. Cancer Research and Treatment, 46, 331.

To evaluate the efficacy of ​hydromorphone-OROS (HM-OROS) in the treatment of sleep disturbances associated with cancer-related pain

Patients took an equianalgesic dose of HM-OROS for two weeks. The dose of HM-OROS was individualized and based on the total dose of previous opioids that were administered on the last day of the screening phase.

• N = 82  
• MEDIAN AGE = 56.1 years (SD = 11.2 years)
• MALES: 67.9 %, FEMALES: 32.1%
• KEY DISEASE CHARACTERISTICS: Patients with cancer; ≥ 20 years of age; cancer pain ≥ 4 on a numeric rating scale (NRS); sleep disturbance ≥ 4 NRS; using oral opioids for cancer-related pain management
• OTHER KEY SAMPLE CHARACTERISTICS: 81.1% stage IV cancer; colorectal 11%; lung 9.5%; pancreas 9%; stomach 8%; breast 7%; 75% prior chemotherapy, radiation, or surgery

• SITE: Multi-site
• SETTING TYPE: Outpatient facility at a university
• LOCATION: Korea

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care

Multicenter, prospective, open-label study with a pre- and post-test

• Sleep disturbance NRS
• Number of times awake after sleep onset
• Pain score
• Need for analgesia for pain prior to bedtime to facilitate sleep
• Korean Brief Pain Inventory (K-BPI)

• The NRS pain score was reduced from 5.3 to 4.1 (p < 0.01).
• The NRS sleep disturbance score was reduced from 5.9 to 4.1 (p < 0.01).
• 26.8% of participants reported a 50% improvement in sleep disturbance, 58.5% reported a 30% improvement in sleep disturbance, and 85% reported an improvement of 10%.
• The K-BPI showed that pain, mood, walking ability, normal work, and sleep improved. The mean sleep score changed from 5.9 to 4.2 (p < 0.01).

HM-OROS improved sleep disturbances in patients with moderate to severe cancer-related pain.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: There was a very high initial number of participants that was reduced by 82 (50%). The initial sample described included 190 participants.

HN-OROS may be an effective drug to treat cancer-related pain and improve sleep disturbance.