Evidence map›Paper›PMID 31831051›Full record

ArticleTrials2019

The effect and mechanism of YH0618 granule on chemotherapy- induced hair loss in patients with breast cancer: study protocol for a randomized, double-blind, multi-center clinical trial.

Jie-Shu You, Li Guo, Mei Huang, Xin-Lei Shi, Man-di Lin, Zhen Guo, Ya-Li Cao, You-Zhi Sun, Qian Xu, Wei-Ling Qu and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
0.5field-weighted citation impact, top 30% 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, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Innovations for cost-effective and eco-friendly solutions to combat chemotherapy-induced alopecia: a narrative systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Pooled it
  2. Pooled it
  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

12 authors at 6 institutions in 2 countries.

Jie-Shu YouSchool of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.
Li GuoGalactophore Department, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong Province, China.
Mei HuangGalactophore Department, The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou, Guangzhou, Guangdong Province, China.
Xin-Lei ShiGalactophore Department, The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou, Guangzhou, Guangdong Province, China.
Man-di LinGalactophore Department, The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou, Guangzhou, Guangdong Province, China.
Zhen GuoGalactophore Department, The Third Hospital of Nanchang, Nanchang, Jiangxi Province, China.
Ya-Li CaoGalactophore Department, The Third Hospital of Nanchang, Nanchang, Jiangxi Province, China.
You-Zhi SunBasic Medical College, Jiangxi University of Chinese Medicine, Nanchang, Jiangxi Province, China.
Qian XuSchool of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.
Wei-Ling QuSchool of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.
Huan-Lan LiuSchool of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.
Jian-Ping ChenSchool of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong. abchen@hku.hk.
First Affiliated Hospital of Guangzhou University of Chinese Medicine · CNGuangzhou University of Chinese Medicine · CNThird Hospital of Nanchang · CNUniversity of Hong Kong · HKGuangdong Provincial Hospital of Traditional Chinese Medicine · CNJiangxi University of Traditional Chinese Medicine · CN

Funding

China Postdoctoral Science Foundation 2018M633037
6 · The paper itself

Abstract

backgroundHair loss is one of the most common side effects of chemotherapy, and can cause persistent negative emotions, further affecting therapeutic effects and reducing the quality of life. However, there are no clinically safe and effective methods to solve the problem at present. Our previous clinical and animal studies showed that a medicinal and edible decoction, YH0618, could significantly promote hair growth in cancer patients after chemotherapy, without interfering with the anti-tumor effects of chemotherapy. Besides, the theory of Chinese Medicine believes that the "Essence of the kidney is reflected on the hair". Therefore, this study will further explore the efficacy of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer by a randomized, double-blind, multi-center clinical trial and elucidate the potential mechanism from the aspect of kidney deficiency or renal dysfunction. METHODS/

designEligible breast cancer patients who will start chemotherapy will be randomly divided into group A (YH0618 granule) and group B (placebo). The chemotherapeutic agents contain taxanes or/and anthracyclines, and the chemotherapy regimen will be for at least six cycles with a cycle every 3 weeks. Subjects assigned to group A will receive YH0618 granules twice a day (6 g each time), 6 days a week, mixed with 300 ml warm water from the first to the fourth chemotherapy cycle. Subjects in group B will receive the placebo granule in the same manner. The primary outcome is the time point of occurrence of hair loss reaching grade II as assessed by the WHO Toxicity Grading Scale, and objective indices of hair quality and hair-follicle growth recorded by a hair and scalp detector before the fifth chemotherapy cycle. Secondary outcomes include changes of facial color and thumbnail color, grading of thumbnails ridging, assessment of quality life, level of fatigue, routine blood test results, hepatic and renal function, and certain medical indicators which can reflect kidney deficiency in Chinese Medicine. DISCUSSION: This research is of great significance for the treatment of cancer and improving the quality of life of cancer patients. The study may provide the most direct evidence for meeting clinical needs and lay a solid scientific foundation for later product development.

trial registrationChinese Clinical Trial Registry, ID: ChiCTR1800020107. Registered on 14 December 2018.

Indexed as

AdolescentAdultAgedAlopeciaAnthracyclinesAntineoplastic AgentsBreast NeoplasmsDouble-Blind MethodDrugs, Chinese HerbalFemaleGlycine maxGlycyrrhizaHumansMiddle AgedMulticenter Studies as TopicQuality of LifeAnthracyclinesAntineoplastic AgentsDrugs, Chinese HerbalTaxoidsAnthracyclinesChemotherapy-induced hair lossKidney deficiency and renal dysfunctionMedicinal and edible compound prescriptionQuality of lifeTaxanesYH0618 granule

Identifiers

PMID31831051
PMCPMC6909490
OpenAlexW2995980758

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.