HGWD Improve the Paclitaxel-related Neurotoxicity in Patients With BC

NCT05566457 | Unknown Phase 2 DMC

• 1 other identifier: LQiao
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• European Organisation for the Research and Treatment of Cancer-Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) questionnaire

  The primary outcome measures was European Organisation for the Research and Treatment of Cancer-Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) questionnaire, which consisted of 20 items that graded the degree of functioning affected by sensory (9 items), motor (8 items) and autonomic CIPN symptoms (3 items). Each item was scored from 1 to 4 (corresponding to answers of none, mild, moderate, and severe) on a Likert scale and subsequently the scores were summed up (total score range, 1-44). Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded). Higher scores represented more symptoms and worse quality of life.

  up to 3 months

Secondary Outcomes (1)

• European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) (version 3)

  up to 3 months

Study Arms (2)

HGWD group

EXPERIMENTAL

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

Drug: Huangqi Guizhi Wuwu decoction (HGWD) infusion packs

control group

PLACEBO COMPARATOR

Patients in the control group and the HGWD group used vitamin E milk and vitamin B12 to smear the limbs three times per day for 14 days.

Drug: Huangqi Guizhi Wuwu decoction (HGWD) infusion packs

Interventions

Huangqi Guizhi Wuwu decoction (HGWD) infusion packs DRUG

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

HGWD group; control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Qiao Li, Dr.

  Department of Medical Oncology, National Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chai Yue, Dr.

CONTACT

+8615910573527; cy972628990@163.com

Qiao Li

CONTACT

87788819; liqiaopumc@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: October 4, 2022
• Study Start: January 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)