{
  "abstract": "Introduction Exertional dyspnoea is highly debilitating. Previous single-dose studies found that prophylactic administration of fentanyl buccal tablet (FBT) improved exertional dyspnoea. In this randomised trial, we compared daily use of prophylactic FBT, oral morphine and placebo on exertional dyspnoea over 14 days.Methods This parallel, double-blind, randomised clinical trial enrolled opioid-tolerant patients with cancer and exertional dyspnoea. After a 5-day observation period, patients were randomised (1:1:1) to receive FBT, morphine or placebo 30 min before daily structured activity for 14 days. Shuttle walk tests (SWTs) were conducted on days 1/5/8/12/15/19. The primary outcome was change in modified Borg Scale dyspnoea intensity during SWTs from day 5 to day 19, analysed using a mixed effects model with treatment, time and treatment×time interaction. SWT distance was a key secondary outcome.Results 67 patients were enrolled and 56 (84%) were randomised. Over the 14-day blinded phase, we observed a significant decrease in the magnitude of dyspnoea intensity change during the SWTs in all three groups, with no significant difference by treatment group (slope change from day 5 to day 19: FBT −2.2 (95% CI −2.9 to –1.6); morphine −1.9 (95% CI −2.7 to –1.2); placebo −2.2 (95% CI −3 to –1.4); time effect p<0.001, treatment×time effect p=0.79). SWT distance increased significantly over time (FBT +93 m; morphine +84 m; placebo +76 m) but did not differ by treatment (p=0.71). Few adverse events were reported.Conclusion All three groups reported less dyspnoea while walking farther; however, no difference was detected between opioids and placebo. These findings should be considered preliminary given the underpowered sample.Trial registration number NCT04188418.",
  "authors": [
    {
      "affiliations": [
        "Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA",
        "Center for Goal Concordant Care Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA",
        "Department of General Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"
      ],
      "name": "David Hui"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, John P and Katherine G McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA"
      ],
      "name": "Soraira Pacheco"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, John P and Katherine G McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA"
      ],
      "name": "Linh Nguyen"
    },
    {
      "affiliations": [
        "Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"
      ],
      "name": "Kristofer Jennings"
    },
    {
      "affiliations": [
        "Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"
      ],
      "name": "Vera de la Cruz"
    },
    {
      "affiliations": [
        "Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"
      ],
      "name": "Penny Stanton"
    },
    {
      "affiliations": [
        "Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"
      ],
      "name": "Raul Laureano"
    },
    {
      "affiliations": [
        "Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"
      ],
      "name": "Amy Ontai"
    },
    {
      "affiliations": [
        "Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USA",
        "Respiratory Services, Valley Regional Hospital, Claremont, New Hampshire, USA"
      ],
      "name": "Donald Mahler"
    },
    {
      "affiliations": [
        "Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"
      ],
      "name": "Eduardo Bruera"
    }
  ],
  "title": "Efficacy of fentanyl buccal tablet and morphine for exertional dyspnoea in patients with cancer: a double-blind, placebo-controlled, randomised clinical trial",
  "uid": "5ae36fce-9826-5865-8f3c-4ead28535c24"
}