A Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan

Primary Objective: To determine the feasible dose range of Painkyl® required for Taiwanese population. Secondary Objectives: To evaluate the efficacy of Painkyl® by calculating squared mean of pain intensity difference at 30 minutes after taking Painkyl® (SPID30, an 11-point scale). To evaluate subjects' satisfaction by conducting global evaluation of medication performance (a 5-point categorical scale). To identify percentage of episodes requiring rescue medication during maintenance treatment period. To evaluate the safety data of Painkyl® for breakthrough pain.

Sex

All

Minimum age

20 Years

Inclusion Criteria:

* a. a stable current regimen of oral opioids equivalent to 60-1000 mg/day of oral morphine or 20-120 mg/day of iv morphine or 25-300 mcg/hr of transdermal fentanyl for one week or longer;
* b. regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control;
* c. at least partial relief of breakthrough pain by use of opioid therapy;
* d. 20 years of age or older;
* e. ability to understand and willingness to sign a written informed consent document;
* f. able to self-administer the study medication correctly or has the availability of a responsible adult caregiver available to administer the study medication correctly;
* g. willing and able to complete patient diary with each pain episode

Exclusion Criteria:

* a. rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics;
* b. history of hypersensitivity or intolerance to fentanyl;
* c. cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression;
* d. psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary;
* e. moderate (Grade 3) to severe (Grade 4) mucositis (subjects with less than moderate mucositis are permitted and must be instructed to not apply the Painkyl® film at a site of inflammation);
* f. abnormal oral mucosa which will impede drug absorption;
* g. currently under other treatments that may alter effect of pain control based on investigator's judgment;
* h. recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse;
* i. use of an investigational drug within 4 weeks preceding this study;
* j. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential;

• BACKGROUNDGreco MT, Corli O, Montanari M, Deandrea S, Zagonel V, Apolone G; Writing Protocol Committee; Cancer Pain Outcome Research Study Group (CPOR SG) Investigators. Epidemiology and pattern of care of breakthrough cancer pain in a longitudinal sample of cancer patients: results from the Cancer Pain Outcome Research Study Group. Clin J Pain. 2011 Jan;27(1):9-18. doi: 10.1097/AJP.0b013e3181edc250. PMID 20842024
• BACKGROUNDRhiner MI, von Gunten CF. Cancer breakthrough pain in the presence of cancer-related chronic pain: fact versus perceptions of health-care providers and patients. J Support Oncol. 2010 Nov-Dec;8(6):232-8. doi: 10.1016/j.suponc.2010.10.006. PMID 21265388
• BACKGROUNDMercadante S. The use of rapid onset opioids for breakthrough cancer pain: the challenge of its dosing. Crit Rev Oncol Hematol. 2011 Dec;80(3):460-5. doi: 10.1016/j.critrevonc.2010.12.002. Epub 2011 Jan 6. PMID 21215653
• BACKGROUNDRauck R, North J, Gever LN, Tagarro I, Finn AL. Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: a randomized, double-blind, placebo-controlled study. Ann Oncol. 2010 Jun;21(6):1308-1314. doi: 10.1093/annonc/mdp541. Epub 2009 Nov 25. PMID 19940014
• DERIVEDChiou TJ, Chao TC, Chao TY, Huang JS, Chang YF, Wang CH. A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan. Cancer Rep (Hoboken). 2019 Oct;2(5):e1179. doi: 10.1002/cnr2.1179. Epub 2019 Apr 23. PMID 32721110