Evidence map›Paper›PMID 27401508›Full record

Trial reportJournal of pain and symptom management2016

Impact of Prophylactic Fentanyl Pectin Nasal Spray on Exercise-Induced Episodic Dyspnea in Cancer Patients: A Double-Blind, Randomized Controlled Trial.

David Hui, Kelly Kilgore, Minjeong Park, Janet Williams, Diane Liu, Eduardo Bruera

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of pain and symptom management, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
3.8field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 47 citations in OpenAlex.

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  11. Article
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  13. Associations between baseline symptom burden as assessed by patient-reported outcomes and overall survival of patients with metastatic cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Article
  14. Review
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  17. Fentanyl treatment for end-of-life dyspnoea relief in advanced cancer patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

David HuiDepartment of Palliative Care and Rehabilitation Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA. Electronic address: dhui@mdanderson.org.
Kelly KilgoreDepartment of Palliative Care and Rehabilitation Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA.
Minjeong ParkDepartment of Biostatistics, M. D. Anderson Cancer Center, Houston, Texas, USA.
Janet WilliamsDepartment of Palliative Care and Rehabilitation Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA.
Diane LiuDepartment of Biostatistics, M. D. Anderson Cancer Center, Houston, Texas, USA.
Eduardo BrueraDepartment of Palliative Care and Rehabilitation Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA.
The University of Texas MD Anderson Cancer Center · US

Funding

Parenteral Hydration in Advanced Cancer Patients: A Randomized Controlled TrialR01CA122292 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI BRUERA, EDUARDO · 2006 to 2009
$2.2M
Methylphenidate for Fatigue in Advanced Cancer PatientsR01NR010162 · NINR · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI BRUERA, EDUARDO · 2006 to 2009
$1.3M
Morphine versus Methadone as First Line Strong Opioid for Cancer PainR01CA124481 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI BRUERA, EDUARDO · 2007 to 2009
$1.2M
Adjuvant Lorazepam for Agitated Delirium in the Palliative Care UnitR21CA186000 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI HUI, DAVID · 2015 to 2016
$399k
NCI NIH HHS R01 CA122292NCI NIH HHS R01 CA124481NCI NIH HHS R21 CA186000NINR NIH HHS R01 NR010162
6 · The paper itself

Abstract

contextEpisodic breathlessness is common and debilitating in cancer patients.

objectivesIn this pilot study, we examined the effect of prophylactic fentanyl pectin nasal spray (FPNS) on exercise-induced dyspnea, physiologic function, and adverse events.

methodsIn this parallel, double-blind randomized placebo-controlled trial, opioid-tolerant patients performed three six-minute walk tests (6MWTs) to induce dyspnea. They were randomized to receive either FPNS (15%-25% of total daily opioid dose each time) or placebo 20 minutes before the second and third 6MWTs. We compared dyspnea Numeric Rating Scale (NRS, 0-10, primary outcome), walk distance, vital signs, neurocognitive function, and adverse events between the first and second 6MWTs (T2-T1) and between the first and third 6MWTs (T3-T1).

resultsTwenty-four patients enrolled, with 96% completion. FPNS was associated with significant within-arm reduction in dyspnea NRS at rest (T2-T1: -0.9 [95% CI -1.7, -0.1]; T3-T1: -1.3 [95% CI -2.0, -0.5]) and at the end of a 6MWT (T2-T1: -2.0 [95% CI -3.5, -0.6]; T3-T1: -2.3 [95% CI -4.0, -0.7]), and longer walk distance (T2-T1 +23.8 m [95% CI +1.3, +46.2 m]; T3-T1: +23.3 m [95% CI -1.7, +48.2]). In the placebo arm, we observed no significant change in walk distance nor dyspnea NRS at rest, but significant reduction in dyspnea NRS at six minutes (T2-T1: -1.7 [95% CI -3.3, -0.1]; T3-T1: -2.5 [95% CI -4.2, -0.9]). Vital signs, neurocognitive function, and adverse effects did not differ significantly.

conclusionFPNS was safe, reduced dyspnea at rest, and increased walk distance in before-after comparison. The placebo effect was substantial, which needs to be factored in future study designs.

trial registrationClinicalTrials.govNCT01832402.

Indexed as

ExerciseAdministration, IntranasalAnalgesics, OpioidDouble-Blind MethodDyspneaFemaleFentanylHumansMaleMiddle AgedNasal SpraysNeoplasmsPectinsPilot ProjectsSeverity of Illness IndexTreatment OutcomeAnalgesics, OpioidFentanylNasal SpraysPectinsDyspneaexercisenasal spraysneoplasmsopioidsrandomized controlled trial

Identifiers

PMID27401508
PMCPMC5075501
OpenAlexW2469931881

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.