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A multicentre, randomised controlled study of a self-proposed Wenyangtongluo Fang for the treatment of oxaliplatin-associated peripheral neurotoxicity

A multicentre, randomised controlled study of a self-proposed Wenyangtongluo Fang for the treatment of oxaliplatin-associated peripheral neurotoxicity

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086568
Enrollment
Unknown
Registered
2024-07-05
Start date
2024-03-22
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxaliplatin-related peripheral neurotoxicity

Interventions

Group A:Oral alone
Group B:Hand-washing alone
Group C:Oral combined hand-washing
Group D:Oral Mecobalamin Tablets

Sponsors

Shanxi Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ?Patients who have been pathologically or cytologically confirmed as intestinal or gastric cancer; ? The age of the patients is 18-80 years old and gender is not limited; ? Patients with KPS = 60 points and expected survival period of not less than 3 months; ? Those who develop peripheral neurotoxicity after receiving oxaliplatin treatment; ? No major visceral organ dysfunction, no cardiovascular and cerebrovascular complications; ? All skin of the limbs is intact; (vii) Those who are accompanied by coldness and fear of cold, no warmth in the limbs; fatigue, qi deficiency; pale and fat tongue, or teeth marks, sunken and thin pulse, and other signs of yang deficiency. (viii) Voluntarily signing the informed consent form and joining this study.

Exclusion criteria

Exclusion criteria: (i) Previous neuropathy of any grade, such as a family history of hereditary/familial neuropathy, especially peripheral neuropathy; (ii) Prior use of paclitaxel; ? Uncontrolled diabetes mellitus, combined with diabetic foot; ? Those who are receiving carbamazepine, phenytoin sodium, valproate, gabapentin, pregabalin, venlafaxine, desvenlafaxine, milnacipran, duloxetine, tricyclic antidepressants; ? Participation in any other clinical study of Chinese or Western medicine for the prevention or treatment of neuropathy; ?Pregnant or lactating women; (vii) Those with a history of allergy to drug exposure or the presence of dermatological lesions of the hands and feet (e.g., eczema); (viii) Psychiatric patients.

Design outcomes

Primary

MeasureTime frame
EORTCQLQ-CIPN20;

Secondary

MeasureTime frame
EORTC QLQ-C30;KPS;Electromyography;Evaluation of toxicity and side effects;

Countries

China

Contacts

Public ContactLi Xiaoli

Shanxi Provincial Hospital of Traditional Chinese Medicine

fangliaokelixiaoli@163.com+86 131 3300 0182

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026