Evidence map›Paper›PMID 31338640›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2020

Impact of a topical lotion, CG428, on permanent chemotherapy-induced alopecia in breast cancer survivors: a pilot randomized double-blind controlled clinical trial (VOLUME RCT).

Danbee Kang, Im-Ryung Kim, Yeon Hee Park, Young Hyuck Im, Di Zhao, Eliseo Guallar, Jin Seok Ahn, Juhee Cho

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04678544 (A Randomized Controlled Trial to Evaluate Effectiveness of Cooling Cap to Prevent Permanent Chemotherapy-induced Alopecia Among Breast Cancer Patients), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 32% 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.

NCT04678544 nacompletednot on this map

A Randomized Controlled Trial to Evaluate Effectiveness of Cooling Cap to Prevent Permanent Chemotherapy-induced Alopecia Among Breast Cancer Patients

TypeinterventionalSponsorSamsung Medical CenterRan2020 to 2022Enrolled170ConditionsNeoplasm, BreastArmsScalp cooling system 2
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. The validity of over-the-counter skin, hair, and nail recommendations for adult patients with cancer: A systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Pooled it
  2. Review
  3. Permanent chemotherapy-induced alopecia: awareness and attitudes among health care providers.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    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

8 authors at 3 institutions in 2 countries.

Danbee KangDepartment of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea.
Im-Ryung KimCancer Education Center, Samsung Comprehensive Cancer Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.
Yeon Hee ParkDivision of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.
Young Hyuck ImDivision of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.
Di ZhaoDepartments of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 2024 E. Monument St, Baltimore, MD, USA.
Eliseo GuallarDepartment of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea.
Jin Seok AhnDivision of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea. jinseok.ahn@samsung.com.
Juhee ChoDepartment of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea. jcho@skku.edu.
Samsung Medical Center · KRSungkyunkwan University · KRJohns Hopkins University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study aimed to evaluate the impact of a topical lotion (CG428) on hair thickness and density in breast cancer survivors with permanent chemotherapy-induced alopecia (PCIA).

methodsThe study was a double-blind, randomized controlled trial which conducted from February 2016 to December 2016 at the Samsung Comprehensive Cancer Center in Seoul, South Korea. Breast cancer patients with PCIA were randomized on average of 3.5 years after chemotherapy. Topical lotion (Batch DT023) is a botanical drug under development containing a novel patented blend of 4 botanical ingredients: citrus, cocoa, guarana, and onion. Participants were asked to self-apply the study product or placebo twice per day for 6 months. Changes in hair density and thickness were assessed using a noninvasive bioengineering device, and patient-reported outcomes were evaluated at 3 and 6 months after randomization.

resultsA total of 35 patients were randomized to intervention (N = 18) or placebo (N = 17). Patients in the intervention group were older than those in the placebo group (52.1 vs. 41.6 years; P < 0.001). The mean hair density (SD) at baseline was 97.6 (6.4) and 126.8 (30.3) hairs/cm DISCUSSION: In this pilot randomized clinical trial, we observed safety, tolerability, and a trend toward the efficacy of CG428 vs. placebo, especially regarding hair density and self-reported improvement.

Indexed as

Breast NeoplasmsCancer SurvivorsAdministration, TopicalAdultAlopeciaAntineoplastic AgentsCacaoCitrusDouble-Blind MethodFemaleHairHumansMiddle AgedOnionsPaulliniaPilot ProjectsAntineoplastic AgentsCG428Plant ExtractsPlant PreparationsBotanicalBreast neoplasmChemotherapyHair densityHair thicknessPermanent chemotherapy-induced alopeciaTopical lotion

Identifiers

PMID31338640
OpenAlexW2963556754

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.