Evidence map›Paper›PMID 28045958›Full record

Trial reportPloS one2017

Topical Recombinant Human Epidermal Growth Factor for Oral Mucositis Induced by Intensive Chemotherapy with Hematopoietic Stem Cell Transplantation: Final Analysis of a Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial.

Ji-Won Kim, Myeong Gyu Kim, Hyun Jung Lee, Youngil Koh, Ji-Hyun Kwon, Inho Kim, Seonyang Park, Byoung Kook Kim, Jung Mi Oh, Kyung Im Kim and 1 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
2.0field-weighted citation impact, top 13% 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

9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. A systematic review of salivary gland hypofunction and/or xerostomia induced by non-surgical cancer therapies: prevention strategies.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Pooled it
  2. Systematic review of growth factors and cytokines for the management of oral mucositis in cancer patients and clinical practice guidelines.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Pooled it
  3. Pooled it
  4. Recombinant Molecules as a New Frontier in Mucositis Therapy.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. 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

11 authors at 6 institutions in 1 country.

Ji-Won KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Myeong Gyu KimCollege of Pharmacy, Seoul National University, Seoul, Republic of Korea.
Hyun Jung LeeDepartment of Internal Medicine, Dongguk University Ilsan Medical Center, Goyang, Republic of Korea.
Youngil KohDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Ji-Hyun KwonDepartment of Internal Medicine, Chungbuk National University Hospital, Cheongju, Republic of Korea.
Inho KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Seonyang ParkDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Byoung Kook KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Jung Mi OhCollege of Pharmacy, Seoul National University, Seoul, Republic of Korea.
Kyung Im KimCollege of Pharmacy, Korea University, Sejong, Republic of Korea.
Sung-Soo YoonDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Seoul National University · KRSeoul National University Hospital · KRChungbuk National University Hospital · KRDongguk University Ilsan Hospital · KRKorea University · KRSeoul National University Bundang Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this study was to evaluate the efficacy and safety of recombinant human epidermal growth factor (rhEGF) oral spray for oral mucositis (OM) induced by intensive chemotherapy with hematopoietic stem cell transplantation. In this phase 2 study, patients were randomized to either rhEGF (50 microg/mL) or placebo in a 1:1 ratio. The primary endpoint was incidence of National Cancer Institute (NCI) grade ≥2 OM. A total of 138 patients were enrolled in this study. In the intention-to-treat analysis, rhEGF did not reduce the incidence of NCI grade ≥2 OM (p = 0.717) nor reduce its duration (p = 0.725). Secondary endpoints including the day of onset and duration of NCI grade ≥2 OM, the incidence of NCI grade ≥3 OM and its duration, and patient-reported quality of life were also similar between the two groups. In the per-protocol analysis, however, the duration of opioid analgesic use was shorter in the rhEGF group (p = 0.036), and recipients in the rhEGF group required a lower cumulative dose of opioid analgesics than those in the placebo group (p = 0.046), among patients with NCI grade ≥2 OM. Adverse events were mild and transient. This study found no evidence to suggest that rhEGF oral spray reduces the incidence of OM. However, further studies are needed to investigate the effect of rhEGF on OM-induced pain reduction after intensive chemotherapy.

Indexed as

Hematopoietic Stem Cell TransplantationAdministration, TopicalAdolescentAdultAgedAnalgesics, OpioidAntineoplastic AgentsDouble-Blind MethodEpidermal Growth FactorFemaleHematologic NeoplasmsHumansIncidenceMaleMiddle AgedQuality of LifeAnalgesics, OpioidAntineoplastic AgentsEpidermal Growth FactorRecombinant Proteins

Identifiers

PMID28045958
PMCPMC5207736
OpenAlexW2570038188

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.