Trial reportMedicine2018
Proportional dose of rapid-onset opioid in breakthrough cancer pain management: An open-label, multicenter study.
Trial report in Medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 21 citations in OpenAlex.
- A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan.Cancer reports (Hoboken, N.J.) · 2019Trial
- A Prospective, Single-Cohort, Open, Multi-center, Observational Study of Sublingual Fentanyl for Breakthrough Cancer Pain: Effectiveness, Safety, and Tolerability in Korean Cancer Patients.Cancer research and treatment · 2025Observational
- Effectiveness of fentanyl buccal soluble film in cancer patients with inadequate breakthrough pain control.BMC palliative care · 2024Article
- Two-year Opioid Prescription Trends in Local Sanitary Agency Naples 3 South, Campania Region, Italy. Descriptive Analyses and AI-based Translational Perspectives.Translational medicine @ UniSa · 2024Article
- Breakthrough pain and rapid-onset opioids in patients with cancer pain: a narrative review.Journal of Yeungnam medical science · 2024Article
- Once again... breakthrough cancer pain: an updated overview.Journal of anesthesia, analgesia and critical care · 2023Review
- Efficacy of adenosylmethionine combined with Si Mo Tang in treatment of neonatal jaundice.American journal of translational research · 2022Article
- Rapid-Onset Opioids for Management of Breakthrough Cancer Pain: Considerations for Daily Practice.Frontiers in pain research (Lausanne, Switzerland) · 2022Review
- Review
- Effects of age and gender in patients receiving doses of opioids for breakthrough pain proportional to background opioid doses.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020Article
- Careful Breakthrough Cancer Pain Treatment through Rapid-Onset Transmucosal Fentanyl Improves the Quality of Life in Cancer Patients: Results from the BEST Multicenter Study.Journal of clinical medicine · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe management of breakthrough pain (BTP) in cancer patients is a challenge. It is clinically useful to evaluate the effectiveness of rapid-onset opioid at a starting dose in proportional to the background opioid regimen. This open-label, multicenter, noncomparative study aimed to assess the efficacy and safety of proportional doses of fentanyl buccal soluble film (FBSF) in patients with breakthrough cancer pain.
methodsThirty patients aged 20 to 70, experiencing 1 to 3 BTP per day, receiving regimens equivalent to 60 to 360 mg/day of oral morphine or 25 to 150 μg/h of transdermal fentanyl ≥1 week, were prospectively recruited. FBSF was administered proportionally based on their current opioid regimen for baseline pain. The percentage of patients requiring dose titration was evaluated. For each BTP episode, changes in pain intensity at 30 minutes (PID30) after dosing, patient's satisfaction, the percentage of episodes requiring rescue medication, and adverse events (AEs) were recorded.
resultsThe percentage of patients who required dose titration was 21.4% (6/28) and 12.0% (3/25) in the full analysis set and per-protocol populations, respectively. The average PID30 was 3.9, and a pain score ≤3 was achieved in 95.1% of the events. Eight out of 367 (2.2%) BTP episodes needed rescue medication. The majority of subjects (75.8%) rated their experience of pain management as good to excellent. A total of 6 drug-related AEs were reported by 3 (10.7%) patients in the safety population.
conclusionsFBSF dose in proportional to the regimen of opioid for baseline pain management is efficacious and well tolerated for the treatment of cancer patients with BTP.
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