HGWD Improve the Paclitaxel-related Neurotoxicity in Patients With BC

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chinese Academy of Medical Sciences

Criteria

The inclusion criteria comprised:

ˑ histologically confirmed untreated BC; ˑ female; ˑage from 18 to 65 years old; ( ˑ Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; ˑat least receiving 4 cycles of nab-PTX (260mg/m2); ˑ grade 2 or greater nab-PTX induced-PN evaluated by European Organisation for the Research and Treatment of Cancer-Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20)(12, 13); ˑ estimated survival time > 6 months. The exclusion criteria were： ˑ a history of diabetes or neurological disorders; ˑmental disorder; ˑabnormal hepatic functions (total bilirubin upper limit of normal (ULN), alanine transaminase/aspartate transaminase ≥ 2.5 × ULN ), renal functions(creatinine ≥ 1.5 × ULN), and hematological functions (absolute neutrophil count ≤ 1.5 × 109/L, platelet count ≤ 80 × 109/L, hemoglobin < 90 g/L); ˑFailure to complete chemotherapy due to treatment-related adverse events; ˑ a family history of a genetic neuropathy; ˑhad received previous treatment with neurotoxic chemotherapy, including oxaliplatin, cisplatin, vinca alkaloid and etc.; ˑ a history of allergy to Chinese medicine.