A Study on the Clinical Efficacy of Fumigation and Washing With Modified Astragalus and Cinnamon Twig Decoction With Five Herbs in the Treatment of Post-Chemotherapy Peripheral Neuropathy

NCT07891403 | Completed Phase 2 DMC

• 1 other identifier: EmeishanHTCM
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to integrate the knowledge system of Traditional Chinese Medicine (TCM) pattern differentiation with TCM knowledge, combining TCM principles with modern Western pharmacology to fundamentally understand the pathogenesis of chemotherapy-induced peripheral neuropathy (CIPN). It employs herbal fumigation and washing therapy for CIPN, offering novel treatment approaches to better guide and assist clinical practice.

Conditions

Post-Chemotherapy Peripheral Neuropathy

Outcome Measures

Primary Outcomes (4)

• Patient Experience

  Numbness, pain, and abnormal sensations in the hands and feet

  On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.

• CIPN Grading Criteria

  On a scale of 0 to 4: Level 0: Asymptomatic; Level 1: Absence of tendon reflexes or numbness (including a prickling sensation), but with no impact on function Level 2: Sensory loss or numbness (including a prickling sensation), affecting function but not daily living activities Level 3: Sensory loss or numbness (including a prickling sensation), affecting daily living activities Level 4: Long-term sensory loss, affecting function

  On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.

• Quality of Life Questionnaire QLQ-C30

  (Original Total Score - Number of Questions) / (Number of Questions × 3) × 100，0-19 points: Level 0 (asymptomatic); 20-39 points: Level 1 (mild); 40-69 points: Level 2 (moderate);70-100 points: Levels 3-4 (severe)

  On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.

• Hospital Anxiety and Depression Scale

  Add up the scores for the 7 questions：0-7 points Normal range, 8-10 points Mild, 11-14 points Moderate, 15-21 points Severe

  On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.

Study Arms (2)

Traditional Chinese Medicine Fumigation and Bathing Group

EXPERIMENTAL

Take Methylcobalamin tablets + herbal steam bath

Drug: Traditional Chinese Medicine Steam Bath

Clear Water Fumigation and Washing Group

PLACEBO COMPARATOR

Take methylcobalamin tablets + warm water steam bath

Drug: Traditional Chinese Medicine Steam Bath

Interventions

Traditional Chinese Medicine Steam Bath DRUG

Wrap the Modified Astragalus and Cinnamon Twig Decoction with Five Ingredients in gauze, soak it in 2,000 ml of clean water for 10 minutes, then pour it into the heating chamber of the steam therapy machine. Set the preheating temperature to 90°C. set the fumigation time to 30 minutes, and begin fumigation once the preheating temperature is reached. Start with both upper limbs, followed by both lower limbs. Perform once daily; one course of treatment consists of 14 days, and a total of two courses of treatment are recommended.

Clear Water Fumigation and Washing Group; Traditional Chinese Medicine Fumigation and Bathing Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Refer to the Chinese Society of Clinical Oncology (CSCO) Clinical Diagnosis and Treatment Guidelines for Common Malignant Tumors, with malignant tumors confirmed by histology or cytology.
• Patients receiving chemotherapy drugs such as oxaliplatin, paclitaxel, and capecitabine
• Karnofsky Performance Status (KPS) ≥ 70 points, Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤ 2 points, survival period ≥ 3 months
• Individuals aged 18 to 80

You may not qualify if:

• Patients with severe cardiac, renal, hepatic, or hematopoietic system impairment;
• Patients with a history of neuropathy, such as diabetic neuropathy or mechanical nerve injury;
• Patients with drug allergies;
• Patients with skin lesions, a tendency to bleed, or infections;
• Patients with intellectual or psychiatric disabilities who are unable to communicate effectively.

Sponsors & Collaborators

• Emeishan Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

EmeishanHTCM

Emeishan City, Sichuan, 614200, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Director

Model Details: This study was a parallel-group controlled trial in which participants were randomly assigned to the treatment group and the control group.

Study Record Dates

• First Submitted: October 11, 2026
• First Posted: October 23, 2026
• Study Start: May 29, 2025
• Primary Completion: September 20, 2026
• Study Completion: September 30, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

CN (1)