logo
    Efficacy and Safety of Fentanyl Inhalant for the Treatment of Breakthrough Cancer Pain: A Multicenter, Randomized, Double- blind, Placebo-controlled Trial
    Research Square (Research Square) (2024)
    Rongbo LinBinbin SongNa LiRong BiaoxueJinghui BaiYong LiuWei WangAnwen LiuSuxia LuoBo LiuYani WuYujie LiXiaohui YuXueying LiuXiangrong DaiXiaoyi LiDongying LiuJian WangYan Huang
    0
    Citation
    21
    Reference
    10
    Related Paper
    Abstract:
    Abstract BackgroundBreakthrough cancer pain (BTcP) has a negative impact on patients’ quality of life, general activities, and is related to worse clinical outcomes. Fentanyl inhalant is a hand-held combination drug-device delivery system providing rapid, multi-dose (25μg/dose) administration of fentanyl via inhalation of a thermally generated aerosol. This multicenter, randomized, placebo-controlled, multiple-crossover, double-blind study evaluated the efficacy, safety, and tolerability of fentanyl inhalant in treating BTcP in opioid-tolerant patients. Methods Each patient was treated and observed for 6 episodes of BTcP (4 with fentanyl inhalant, 2 with placebo). During each episode of targeted BTcP, patients were allowed up to six inhalations. Primary outcome was the time-weighted sum of PID (pain intensity difference) scores at 30 minutes (SPID30). Results A total of 335 BTcP episodes in 59 patients were treated. The mean SPID30 was -97.4 ± 48.43 for fentanyl inhalant-treated episodes, and -64.6 ± 40.25 for placebo-treated episodes (p<0.001). Significant differences in PID for episodes treated with fentanyl inhalant versus placebo was seen as early as 4 minutes and maintained for up to 60 minutes. The percentage of episodes reported PI (pain intensity) scores ≤ 3, a ≥ 33% or ≥ 50% reduction in PI scores at 30 minutes, PR30 (pain relief scores at 30 minutes) and SPID60 favored fentanyl inhalant over placebo. Only 4.4% of BTcP episodes required rescue medication in fentanyl inhalant group. Most AEs were of mild or moderate severity and typical of opioid drugs. Conclusion Fentanyl inhalant was efficacious, safe, and well tolerated in the management of BTcP. Trial registration ClinicalTrials.gov: NCT05531422
    Keywords:
    Breakthrough Pain
    Intoxicative inhalant
    Topics:
    Pain Management and Opioid Use
    Pain Management and Placebo Effect
    Pediatric Pain Management Techniques
    PDF
    EE176 Cost-Utility Analysis of Fentanyl Sublingual Formulation in the Treatment of Breakthrough Pain in Adults With Cancer, Already on Opioid Maintenance Therapy for Chronic Cancer Pain in Italy
    Value in Health (2022)
    Martina PaolettiAndrea MarcellusiF.S. Mennini
    Breakthrough Pain
    Citations (0)
    Intra- and Interindividual Variabilities in the Pharmacokinetics of Fentanyl Buccal Soluble Film in Healthy Subjects
    Clinical Drug Investigation (2011)
    Andrew DaviesA. L. FinnIgnacio Tagarro
    Breakthrough Pain
    Citations (11)
    Transdermal fentanyl for cancer pain
    Cochrane database of systematic reviews (2012)
    Gina HadleySheena DerryR Andrew MoorePhilip J Wiffen
    This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To determine the analgesic efficacy of transdermal fentanyl for relief of cancer pain. To assess the adverse effects associated with the clinical use of transdermal fentanyl for relief of cancer pain.
    Transdermal patch
    Citations (21)
    [Combinatorial Use of Rapid-Onset Opioid and Short-Acting Opioid Is Effective against Breakthrough Cancer Pain].
    PubMed (2018)
    Yasunori ShikadaYasunori EmiTakuro KometaniToshiaki OchiaiMisa Fujii
    Breakthrough cancer pain is divided into "predictable breakthrough pain" and "unpredictable breakthrough pain". Uncontrolled breakthrough pain in cancer negatively affects the quality of life of the patients. The short-acting opioid(SAO) requires considerable time to produce analgesia, and is not adequate as a rescue drug. The rapid-onset opioid(ROO)immediately produces analgesia, but its appropriate usage is difficult. For instance, the frequency and interval of ROO usage is limited, making the optimization of dosage cumbersome. Therefore, ROO has not yet gained popularity. Here, we report that a combinatorial use of ROO and SAO is effective against breakthrough cancer pain, with SAO and ROO being suitable for "predictable breakthrough pain", and "unpredictable breakthrough pain", respectively. The effectiveness and safety of this combination were assessed for many patients with breakthrough cancer pain.
    Breakthrough Pain
    Citations (0)
    Sublingual Methadone for the Management of Cancer-Related Breakthrough Pain: A Pilot Study
    Journal of Palliative Medicine (2007)
    Neil A. HagenKim FisherCarla Stiles
    Background: Breakthrough pain is a highly prevalent and difficult to manage cancer pain problem. Current strategies are frequently ineffective, in part because of a mismatch between the sudden onset and brief duration of breakthrough pain and the slower onset and more prolonged duration of oral immediate-release opioids. Novel analgesic interventions are needed to provide a closer match between the temporal profile of the pain and the pharmacodynamics of the pain medication, and novel models of study of breakthrough pain are needed to evaluate them. Methods: This is an open-label feasibility study of a model to evaluate sublingual methadone for cancer-related breakthrough pain. The model has three phases: screening, upward titration, and optimal dose evaluation. Results: Seven patients with breakthrough pain because of cancer entered the upward titration phase of the trial, and 61 episodes of breakthrough pain were evaluated with sublingual methadone at escalating doses ranging from 2–18 mg. Toxicity was generally mild and similar to patients’ prior breakthrough medication. Four patients entered the optimal dose evaluation phase, and 39 discrete episodes of breakthrough pain were available for evaluation. Significant relief of pain occurred with a median onset of 5 minutes, and no serious adverse events were encountered. Conclusions: This model of assessment of breakthrough pain, whereby each episode of pain is treated as a separate data set and multiple discrete episodes of breakthrough pain are assessed every 5 minutes in each patient, appears to be feasible within the cancer pain population. Preliminary results suggest a very rapid onset of relief of breakthrough pain with sublingual methadone when administered at the optimal dose, consistent with a highly favorable early pharmacodynamic profile of methadone administered via this route. Further study is warranted.
    Breakthrough Pain
    Pain Assessment
    Citations (46)
    Intra- and Interindividual Variabilities in the Pharmacokinetics of Fentanyl Buccal Soluble Film in Healthy Subjects
    Clinical Drug Investigation (2011)
    Andrew DaviesA. L. FinnIgnacio Tagarro
    Breakthrough Pain
    Citations (13)
    Transdermal fentanyl analgesia for patients with advanced cancer of the observation
    Contemporary Medicine (2008)
    Guoyuan Wu
    Objective Observation of transdermal fentanyl analgesic efficacy in patients with advanced cancer.Methods 86 patients with advanced cancer pain were observed for a period of 2 years.Results Transdermal fentanyl analgesia in patients with advanced cancer of the overall efficiency of about 88.40%,significantly efficiency of 52.30%.Conclusion Transdermal fentanyl for pain relief is effective in the treatment of advanced cancer.
    Transdermal patch
    Citations (0)