Evidence map›Paper›PMID 31977883›Full record

ArticleMedicine2020

Clinical study for external Chinese herbal medicine LC09 treating hand-foot skin reaction associated with the antitumor targeted drugs: Protocol for a prospective, randomized, controlled, double-blind, and monocentric clinical trial.

Gui Wang, Liqun Jia, Yuying Pei, Ran Yu, Yu Gao, Chao Deng, Yanni Lou

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 34% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. 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

7 authors at 2 institutions in 1 country.

Gui WangDepartment of Oncology of Integrative Chinese and Western Medicine, China-Japan Friendship Hospital.
Liqun JiaDepartment of Oncology of Integrative Chinese and Western Medicine, China-Japan Friendship Hospital.
Yuying PeiBeijing University of Chinese Medicine, Beijing, China.
Ran YuDepartment of Oncology of Integrative Chinese and Western Medicine, China-Japan Friendship Hospital.
Yu GaoDepartment of Oncology of Integrative Chinese and Western Medicine, China-Japan Friendship Hospital.
Chao DengDepartment of Oncology of Integrative Chinese and Western Medicine, China-Japan Friendship Hospital.
Yanni LouDepartment of Oncology of Integrative Chinese and Western Medicine, China-Japan Friendship Hospital.
China-Japan Friendship Hospital · CNBeijing University of Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMolecular targeted anticancer drugs such as multikinase inhibitors have shown obvious therapeutic advantages in a variety of tumors. The occurrence of hand-foot skin reaction (HFSR) is positively correlated with therapeutic effect, but it is also the most common cause of dose limiting toxicity for this treatment. This can lead to interruption or decrement of the treatment, a reduction in quality of life for patients, as well as potentially leading to secondary infections. As a result, the curative effect of targeted anticancer drugs will be negatively impacted. Currently, there is no certain and effective therapy. External use of Chinese herb medicine LC09 in the early treatment of HFSR has shown positive outcomes, but it is necessary to carry out further clinical research to confirm.

objectivesThe purpose of this study was to investigate the efficacy and safety of topical soaks of Chinese herbal medicine LC09 for HFSR induced by molecular targeted anticancer drugs.

methodsThe trial is a prospective, randomized, controlled, double-blind, monocentric, and interventional study. A total of 66 patients with HFSR will be recruited and randomly assigned to receive either LC09 Granules or placebo. The primary outcomes are the assessment of HFSR grade and pain score. The secondary outcomes are the evaluation of the quality of life, incidence of targeted drug dosage reduction, and incidence of targeted drug withdrawal. DISCUSSION: This prospective, randomized clinical trial will provide valuable data regarding the efficacy and safety of topical soak treatments with LC09 granules for HFSR. Positive results would provide evidence-based complementary therapeutic approach future treatments of HFSR.

trial registrationChinese Clinical Trial Registry, http://www.chictr.org.cn, ChiCTR1900023679. Registered on 7 June 2019.

Indexed as

Antineoplastic AgentsBathsDouble-Blind MethodDrugs, Chinese HerbalFootHandHumansProspective StudiesRandomized Controlled Trials as TopicSkin DiseasesTreatment OutcomeAntineoplastic AgentsDrugs, Chinese Herbal

Identifiers

PMID31977883
PMCPMC7004671
OpenAlexW3001398830

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.