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HGWD Improve the Paclitaxel-related Neurotoxicity in Patients With BC

NCT05566457 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-10-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Huangqi Guizhi Wuwu decoction (HGWD) infusion packs

Patients in the HGWD group (n = 46) soaked and washed Immersion and Washing limbs with HGWD infusion packs, followed by smearing limbs with vitamin E and vitamin B12. The composition of HGWD infusion pack was: 60g Radix Astragali (Huangqi), 15g Ramulus Cinnamomi (Guizhi), 15g Paeonia lactiflora (Baishao), 15g Gentiana (Qinjiao), 6g Scorpio (Quan-Xie), 20g Rhizoma Zingiberis Recens (Shengjiang), 20 Jujubes (Dazao), 30g Geranium wilfordii (Laoguancao), 12g radix sileris (Fangfeng), 30g Spatholobus suberectus (Jixueteng), 15g Ligusticum (Chuanxiong), 15g Poria (Fuling), and 15g Radixcyathulae (Chuanniuxi). HGWD infusion pack was boiled in water and extraction was performed twice to obtain a total of 500 ml drug-containing water. The drug-containing water was maintained at 39 to 40℃ for soaking and washing limbs for 20min twice a day for consecutive 14 days

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Qiao Li, Dr. · Department of Medical Oncology, National Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2023-01-01
Completion
2023-01-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05566457 on ClinicalTrials.gov