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2017 ASCO Annual Meeting!

Session: Patient and Survivor Care

Type: Poster Session

Time: Saturday June 3, 1:15 PM to 4:45 PM

Location: Hall A

Effect of prophylactic fentanyl buccal tablet (FBT) on exertional dyspnea in patients with cancer: A pilot double-blind, placebo-controlled, randomized trial.

Symptom Management/Supportive Care/Palliative Care

Patient and Survivor Care

2017 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Session (Board #74)

J Clin Oncol 35, 2017 (suppl; abstr 10085)

Author(s): David Hui, Kelly L. Kilgore, Susan Frisbee-Hume, Minjeong Park, Diane D Liu, Eduardo Bruera; The University of Texas MD Anderson Cancer Center, Houston, TX

Abstract Disclosures


Background: Exertional dyspnea is one of the most common, debilitating and difficult-to-treat symptoms in cancer patients. Few clinical trials have been conducted. We tested the hypothesis that FBT, a rapid onset opioid, given prophylactically prior to exertion can improve exertional dyspnea. Methods: In this double-blind parallel (1:1) RCT, we asked cancer patients who were opioid-tolerant and had exertional dyspnea to complete a 6 minute walk test (6MWT) at baseline, and then randomly assigned them to either FBT proportional to 20-50% of daily dose or placebo 30 minutes before a second 6MWT. The primary outcome was a validated 11-point dyspnea NRS assessing dyspnea “now” (where 0 = none and 10 = worst possible) every minute during each 6MWT. Secondary outcomes included walk distance, vital signs and neurocognitive testing, adverse effects, and global impression. Ten evaluable patients in the FBT provided 80% power to detect an effect size as small as 1.0 using a two-sided paired t-test with a significance level of 5% to compare the change of dyspnea between the first and second walk tests. We compared the outcomes between the first and second 6MWTs using paired t-test. Results: Among 22 patients enrolled, 20 (91%) completed the study (9 FBT, 11 placebo). FBT was associated with a significant within-arm reduction in dyspnea NRS between 0 and 6 minutes (mean change -2.4, 95% confidence interval [CI] -3.5, -1.3) and respiratory rate (mean change -2.6, 95% CI -4.7, -0.4). Placebo was also associated with a non-statistically significant decrease in dyspnea (mean change -1.1). Between arm comparison of dyspnea scores in the second 6MWT favored FBT, albeit not statistically significant (estimate -0.25, P = 0.068). Global impression revealed more patients in the FBT group than placebo group reporting their dyspnea was at least “somewhat better” in the second 6MWT (4/9 vs. 0/11, P = 0.03). The other secondary outcomes did not differ significantly between arms. Conclusions: These data support our hypothesis that proportionally dosed FBT was associated with improvement in exertional dyspnea, and highlights the need for larger confirmatory trials. Clinical trial information: NCT01856114

Other Abstracts in this Sub-Category:


1. Managing cancer and living meaningfully (CALM): A randomized controlled trial of a psychological intervention for patients with advanced cancer.

Meeting: 2017 ASCO Annual Meeting Abstract No: LBA10001 First Author: Gary Rodin
Category: Patient and Survivor Care - Symptom Management/Supportive Care/Palliative Care


2. SCORAD III: Randomized noninferiority phase III trial of single-dose radiotherapy (RT) compared to multifraction RT in patients (pts) with metastatic spinal canal compression (SCC).

Meeting: 2017 ASCO Annual Meeting Abstract No: LBA10004 First Author: Peter Hoskin
Category: Patient and Survivor Care - Symptom Management/Supportive Care/Palliative Care


3. Effect of inpatient palliative care during hematopoietic stem cell transplantation (HCT) hospitalization on psychological distress at six months post-HCT.

Meeting: 2017 ASCO Annual Meeting Abstract No: 10005 First Author: Areej El-Jawahri
Category: Patient and Survivor Care - Symptom Management/Supportive Care/Palliative Care