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A multicenter, randomized, controlled clinical study of warm acupuncture in the treatment of oxaliplatin-induced peripheral neuropathy

A multicenter, randomized, controlled clinical study of warm acupuncture in the treatment of oxaliplatin-induced peripheral neuropathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082506
Enrollment
Unknown
Registered
2024-03-30
Start date
2024-03-31
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

oxaliplatin-induced peripheral neuropathy

Interventions

Warm Acupuncture Group:The patient took a prone position to fully expose the acupuncture and moxibustion position. Doctors Use 75% alcohol to locally disinfect the acupuncture site, with acupoints inc
Usual Care Group:Advise participants to avoid contact with cold and hot water
Wear gloves and outer socks to protect hands and feet and avoid direct contact with metal objects
Prohibition of drinking alcohol
Avoid hiking exercises.

Sponsors

Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) All cases were confirmed by histopathological evidence as intestinal malignant tumors; (2) Age 18-85 years old; (3) Chemotherapy with mFOLFOX6 or XELOX regimen, and 3 months after completion =of chemotherapy; (4) Patients with peripheral neuropathy after chemotherapy, NCI CTCAE version 4.0 neurotoxicity classification = grade 2; (5) Those who do not have serious damage to the heart, liver, kidney or hematopoietic system, or who have abnormalities but meet the enrollment requirements after symptomatic treatment (such as whitening, platelet promotion, liver protection, etc.); (6) Patients with a Karl Fischer score of 60 or more are expected to survive = 6 months; (7) No intellectual or mental disorders, normal language skills, and the ability to judge their own feelings and general conditions; (8) Voluntarily participate in the trial and give informed consent.

Exclusion criteria

Exclusion criteria: (1) Peripheral neuropathy caused by other reasons, such as diabetes, infection, radiotherapy, poisoning, etc., or the patient originally suffered from peripheral paresthesia and nervous system abnormalities. and those who are receiving other drugs with neurotoxicity; (2) Patients with severe heart, liver and kidney insufficiency; (3) Pregnant and lactating women; (4) Those who are accompanied by mental and mental disorders and cannot cooperate; (5) Severe skin diseases or broken skin of the limbs; (6) Received acupuncture treatment for any indication within the past month.

Design outcomes

Primary

MeasureTime frame
NCI-CTCAE4.0 Neurotoxicity Grading;EORTC QLQ-C30 Quality of Life Rating Scale;

Secondary

MeasureTime frame
EORTC QLQ-CIPN20 Tablet;

Countries

China

Contacts

Public ContactHuo Jiege

Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine

hjg16688@163.com+86 153 1201 9156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 31, 2026