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NCT05566457

HGWD Improve the Paclitaxel-related Neurotoxicity in Patients With BC

Status unknown Phase 2 Last updated 4 October 2022
What this trial tests

Phase 2 trial testing Huangqi Guizhi Wuwu decoction (HGWD) infusion packs in Breast Cancer in 92 participants. Status unknown.

Timeline
1 January 2020
Primary endpoint
1 January 2023
1 January 2023

Quick facts

Lead sponsorChinese Academy of Medical Sciences
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment92
Start date1 January 2020
Primary completion1 January 2023
Estimated completion1 January 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Chinese Academy of Medical Sciences — full company profile →

Who can join

Adults 18 to 65, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The current treatments for albumin-bound paclitaxel (nab-PTX) -related peripheral neurotoxicity (PN) mainly included cryotherapy and compression therapy , oral B group vitamin , and duloxetine. However, treatment effectiveness of these three methods is limited. Huangqi Guizhi Wuwu decoction (HGWD) is an herbal formula recorded in "Synopsis of the Golden Chamber" for improving limb pain, tingling, and numbness, which is composed of five crude drugs (Astragali Radix, Cinnamomi Ramulus, Paeoniae Radix Alba, Zingiberis Rhizoma Recens, and Jujubae Fructus)(9). Recently, HGWD has been shown to be effective in the treatment of oxaliplatin- and diabetic-related PNs . But there are no prospective studies to explore the efficacy of HGWD in the treatment of nab-PTX-induced PN in patients with BC. Therefore, we conducted this prospective randomized controlled study to investigate the efficacy and safety of HGWD to prevent nab-PTX-induced PN in patients with BC. The primary aim of this study was to assess the prevention of nab-PTX-induced PN by soaking hands and/or feet with HGWD when compared to placebo.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Prospective, Randomized, Placebo-Controlled Study Assessing the Efficacy of Chinese Herbal Medicine (Huangqi Guizhi Wuwu Decoction) in the Treatment of Albumin-Bound Paclitaxel-Induced Peripheral Neuropathy.
    Chai Y, Zhao F, Ye P, Ma F, et al · · 2023 · cited 5× · PMID 36675434 · DOI 10.3390/jcm12020505

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Other recruiting trials for Breast Cancer

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