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NCT05566457
HGWD Improve the Paclitaxel-related Neurotoxicity in Patients With BC
Phase 2 trial testing Huangqi Guizhi Wuwu decoction (HGWD) infusion packs in Breast Cancer in 92 participants. Status unknown.
1 January 2023
Quick facts
| Lead sponsor | Chinese Academy of Medical Sciences |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 92 |
| Start date | 1 January 2020 |
| Primary completion | 1 January 2023 |
| Estimated completion | 1 January 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Huangqi Guizhi Wuwu decoction (HGWD) infusion packs — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05566457
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05566457 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese Academy of Medical Sciences
- Last refreshed: 4 October 2022
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