Evidence map›Paper›PMID 27628064›Full record

Trial reportInternational journal of clinical oncology2017

Phase II trial of subcutaneous methylnaltrexone in the treatment of severe opioid-induced constipation (OIC) in cancer patients: an exploratory study.

Masanori Mori, Yongli Ji, Santosh Kumar, Takamaru Ashikaga, Steven Ades

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01004393 (Phase II Trial of Subcutaneous Methylnaltrexone in the Treatment of Severe Opioid-induced Constipation in Cancer Patients), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT01004393 phase2completednot on this map

Phase II Trial of Subcutaneous Methylnaltrexone in the Treatment of Severe Opioid-induced Constipation in Cancer Patients

TypeinterventionalSponsorUniversity of VermontRan2009 to 2013Enrolled12ConditionsNeoplasms, Constipation, Opioid-Related DisordersArmsMethylnaltrexone bromide
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
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

5 authors.

Masanori MoriPalliative Care Team, Seirei Mikatahara General Hospital, 3453, Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka, 433-8558, Japan. masanori.mori@sis.seirei.or.jp.
Yongli JiDivision of Hematology/Oncology, Massachusetts General Hospital, Center for Cancer Care at Exeter Hospital, 5 Alumni Drive, Exeter, NH, 03833, USA.
Santosh KumarWilmot Cancer Center, University of Rochester Medical Center, 601 Elmwood Avenue, Rochester, NY, 14642, USA.
Takamaru AshikagaDepartment of Medical Biostatistics, University of Vermont College of Medicine, 27 Hills Building, 105 Carrigan Drive, Burlington, VT, 05405, USA.
Steven AdesDivision of Hematology and Oncology, University of Vermont Cancer Center, Given E-214-UVM363, 89 Beaumont Avenue, Burlington, VT, 05405, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMethylnaltrexone is a peripherally acting mu-opioid receptor antagonist that has been shown to relieve severe opioid-induced constipation (OIC) in patients with advanced disease receiving palliative care. Its efficacy remains unknown in cancer patients who are not terminally ill. The primary aim of this study was to evaluate the efficacy of methylnaltrexone over 48 h in cancer patients who were not terminally ill.

methodsIn this single-dose phase II trial, cancer patients with a prognosis of ≥3 months and OIC with <3 laxations during the preceding week were eligible. The primary endpoint was a rescue-free laxation ≤4 h after a single dose of methylnaltrexone. Friedman's two-way analysis of variance was conducted for the number of laxations, pain and withdrawal scales, and laxation- and constipation-related symptoms. Univariate/bivariate Cox proportional hazard models for laxation times were employed.

resultsTwelve patients received methylnaltrexone. Eleven patients had an ECOG performance status of 1 or 2. Four (33.3 %) and 5 (41.7 %) patients had rescue-free laxation within 4 and 24 h, respectively, and 10 (83.3 %) had laxation within 48 h (p = 0.006). Difficulty passing a stool improved significantly over 48 h (p = 0.029). The bivariate Cox models revealed that a shorter time to laxation was associated with a higher baseline morphine equivalent daily dose (hazard ratio, 1.02 per 1 mg; p = 0.018) and a smaller number of laxations in the preceding week (hazard ratio, 0.13 per one laxation; p = 0.035). Patients tolerated methylnaltrexone well without opioid withdrawal.

conclusionsMethylnaltrexone may relieve severe OIC in cancer patients who are not terminally ill. A larger prospective study is justified in this population. (NCT01004393, https://clinicaltrials.gov/show/NCT01004393 ).

Indexed as

AdultAgedAged, 80 and overAnalgesics, OpioidConstipationFemaleHumansInjections, SubcutaneousMaleMiddle AgedNaltrexoneNarcotic AntagonistsNeoplasmsNeoplasm StagingPrognosisQuaternary Ammonium CompoundsAnalgesics, OpioidmethylnaltrexoneNaltrexoneNarcotic AntagonistsQuaternary Ammonium CompoundsCancerMethylnaltrexoneOpioid-induced constipationPhase II trial

Identifiers

PMID27628064

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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.