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

Research output: Contribution to journalArticle

Abstract

Purpose: This 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). Methods: The 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. Results: A 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/cm2 in the intervention and placebo group, respectively (P = 0.005). The corresponding values for hair thickness were 49.9 (12.7) and 48.1 (8.4) μm, respectively. After 6 months, hair density had increased by 34.7 and 24.9% compared with baseline in the intervention and control groups, respectively (P = 0.37). Corresponding values for hair thickness were 19.8 and 35.6%, respectively (P = 0.23). Similar findings were observed after age adjustment. 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.

Original languageEnglish (US)
JournalSupportive Care in Cancer
DOIs
StatePublished - Jan 1 2019

Fingerprint

Alopecia
Controlled Clinical Trials
Hair
Survivors
Breast Neoplasms
Drug Therapy
Placebos
Paullinia
Randomized Controlled Trials
Bioengineering
Republic of Korea
Onions
Citrus
Random Allocation
Safety
Equipment and Supplies
Control Groups
Pharmaceutical Preparations

Keywords

  • Botanical
  • Breast neoplasm
  • Chemotherapy
  • Hair density
  • Hair thickness
  • Permanent chemotherapy-induced alopecia
  • Topical lotion

ASJC Scopus subject areas

  • Oncology

Cite this

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

In: Supportive Care in Cancer, 01.01.2019.

Research output: Contribution to journalArticle

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abstract = "Purpose: This 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). Methods: The 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. Results: A 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/cm2 in the intervention and placebo group, respectively (P = 0.005). The corresponding values for hair thickness were 49.9 (12.7) and 48.1 (8.4) μm, respectively. After 6 months, hair density had increased by 34.7 and 24.9{\%} compared with baseline in the intervention and control groups, respectively (P = 0.37). Corresponding values for hair thickness were 19.8 and 35.6{\%}, respectively (P = 0.23). Similar findings were observed after age adjustment. 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.",
keywords = "Botanical, Breast neoplasm, Chemotherapy, Hair density, Hair thickness, Permanent chemotherapy-induced alopecia, Topical lotion",
author = "Danbee Kang and Kim, {Im Ryung} and Park, {Yeon Hee} and Im, {Young Hyuck} and Di Zhao and Eliseo Guallar and Ahn, {Jin Seok} and Juhee Cho",
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T2 - a pilot randomized double-blind controlled clinical trial (VOLUME RCT)

AU - Kang, Danbee

AU - Kim, Im Ryung

AU - Park, Yeon Hee

AU - Im, Young Hyuck

AU - Zhao, Di

AU - Guallar, Eliseo

AU - Ahn, Jin Seok

AU - Cho, Juhee

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N2 - Purpose: This 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). Methods: The 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. Results: A 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/cm2 in the intervention and placebo group, respectively (P = 0.005). The corresponding values for hair thickness were 49.9 (12.7) and 48.1 (8.4) μm, respectively. After 6 months, hair density had increased by 34.7 and 24.9% compared with baseline in the intervention and control groups, respectively (P = 0.37). Corresponding values for hair thickness were 19.8 and 35.6%, respectively (P = 0.23). Similar findings were observed after age adjustment. 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.

AB - Purpose: This 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). Methods: The 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. Results: A 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/cm2 in the intervention and placebo group, respectively (P = 0.005). The corresponding values for hair thickness were 49.9 (12.7) and 48.1 (8.4) μm, respectively. After 6 months, hair density had increased by 34.7 and 24.9% compared with baseline in the intervention and control groups, respectively (P = 0.37). Corresponding values for hair thickness were 19.8 and 35.6%, respectively (P = 0.23). Similar findings were observed after age adjustment. 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.

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