Evidence map›Paper›PMID 31401605›Full record

ArticleBMJ open2019

Effectiveness of omega-3 fatty acid administration on completion rate of adjuvant chemotherapy for biliary tract cancer: study protocol for a single-centre, open-label, single-arm, historically controlled study.

Kimihiko Ueno, Tetsuo Ajiki, Daisuke Tsugawa, Masayuki Akita, Yu Hashimoto, Masahide Awazu, Hideyo Mukubo, Shohei Komatsu, Kaori Kuramitsu, Sachio Terai and 4 more

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 33% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
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  3. Article
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

14 authors at 1 institution in 1 country.

Kimihiko UenoHepato-Biliary-Pancreatic Surgery, Kobe University, Kobe, Japan kueno.rhmn@gmail.com.
Tetsuo Ajiki
Daisuke TsugawaHepato-Biliary-Pancreatic Surgery, Kobe University, Kobe, Japan.
Masayuki AkitaHepato-Biliary-Pancreatic Surgery, Kobe University, Kobe, Japan.
Yu HashimotoHepato-Biliary-Pancreatic Surgery, Kobe University, Kobe, Japan.
Masahide Awazu
Hideyo MukuboHepato-Biliary-Pancreatic Surgery, Kobe University, Kobe, Japan.
Shohei Komatsu
Kaori Kuramitsu
Sachio Terai
Motofumi TanakaHepato-Biliary-Pancreatic Surgery, Kobe University, Kobe, Japan.
Hirichika ToyamaHepato-Biliary-Pancreatic Surgery, Kobe University, Kobe, Japan.
Masahiro Kido
Takumi FukumotoHepato-Biliary-Pancreatic Surgery, Kobe University, Kobe, Japan.
Kobe University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMultimodal treatment prolongs the survival of patients with biliary tract cancer (BTC). However, the chemotherapy choices for this disease are few, and completing each chemotherapy session is important. Adjuvant chemotherapy has been attempted for BTC, but has only had a 75% completion rate. Body weight loss and cholangitis are reasons for the interruption of chemotherapy. Previous reports suggested that nutritional intervention with omega-3 fatty acids maintained body weight and improved the completion rate for chemotherapy. Moreover, omega-3 fatty acids have an anti-inflammatory effect. Therefore, we theorised that omega-3 fatty acids would improve the completion rate of adjuvant chemotherapy in patients with BTC. The aim of this study is thus to evaluate the effectiveness of omega-3 fatty acids for patients planning adjuvant chemotherapy for BTC. METHOD AND ANALYSIS: This study is a single-centre, open-label, single-arm, historically controlled study with a planned enrolment of 55 participants. Protocol treatment consists of four courses of S-1 adjuvant chemotherapy and an oral omega-3 fatty acid pharmaceutic adjuvant (LOTRIGA 2 g (Takeda Pharmaceutical Co.)), which includes 2 g of omega-3 fatty acids from day 1 until day 168 of the treatment period. The primary endpoint is the completion rate of four total courses of S-1. Secondary endpoints are postoperative cholangitis, time to recurrence or distant metastasis, changes in nutritional index, changes in the lymphocyte blast transformation test induced by phytohaemagglutinin, and concanavalin A and diamine oxidase serum activity during adjuvant chemotherapy. All adverse events will be evaluated. ETHICS AND DISSEMINATION: This protocol was approved by the Institutional Review Board of Kobe University Hospital. The findings from this study will be presented at national and international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: UMIN000031247.

Indexed as

Chemotherapy, AdjuvantAdministration, OralBiliary Tract NeoplasmsCombined Modality TherapyDisease-Free SurvivalFatty Acids, Omega-3Historically Controlled StudyHumansResearch DesignTreatment OutcomeFatty Acids, Omega-3adjuvantbiliary tract cancerchemotherapyomega-3 fatty acidS-1

Identifiers

PMID31401605
PMCPMC6701576
OpenAlexW2968755205

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Registered trials

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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.