HGWD Improve the Paclitaxel-related Neurotoxicity in Patients With BC

Trial Title: HGWD Improve the Paclitaxel-related Neurotoxicity in Patients With BC

NCT ID: NCT05566457

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Neurotoxicity Syndromes

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: This open-label, single-center, prospective, randomized controlled trial was planned to be conducted in the National Cancer Center in China from January 2020 to June 2022.The eligible paticipants were assigned randomly in a 1:1 ratio to a study group (HGWD group) or a control group. PASS software (version 15.0) (Kaysville, Utah, USA) was used to calculate the sample size. Assuming α = 0.05 and 1-β = 0.8, a total of 80 patients were needed for the aim of decreasing the grade 2-3 PN from 60% to 30%. Assuming a lost-to-follow-up rate of 15%, a total of 92 patients were needed.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Huangqi Guizhi Wuwu decoction (HGWD) infusion packs
Description: 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
Arm group label: HGWD group
Arm group label: control group

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.

Detailed description: This open-label, single-center, prospective, randomized controlled trial was planned to be conducted in the National Cancer Center in China from January 2020 to June 2022.The eligible paticipants were assigned randomly in a 1:1 ratio to a study group (HGWD group) or a control group. PASS software (version 15.0) (Kaysville, Utah, USA) was used to calculate the sample size. Assuming α = 0.05 and 1-β = 0.8, a total of 80 patients were needed for the aim of decreasing the grade 2-3 PN from 60% to 30%. Assuming a lost-to-follow-up rate of 15%, a total of 92 patients were needed. 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.

Criteria for eligibility:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Address:
City: Beijing
Zip: 100021
Country: China

Status: Recruiting

Contact:
Last name: Qiao Li

Phone: 8687788120

Phone ext: 8687788120
Email: Liqiaopumc@qq.com

Start date: January 1, 2020

Completion date: January 1, 2023

Lead sponsor:
Agency: Chinese Academy of Medical Sciences
Agency class: Other

Source: ChineseAMS

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05566457