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A multicenter, randomized, double-blind, placebo-controlled phase III clinical study on the prevention of peripheral neurotoxicity of oxaliplatin by yiqiwenjing recipe

A multicenter, randomized, double-blind, placebo-controlled phase III clinical study on the prevention of peripheral neurotoxicity of oxaliplatin by yiqiwenjing recipe

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003507
Enrollment
Unknown
Registered
2020-07-22
Start date
2020-09-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Peripheral neurotoxicity of oxaliplatin

Interventions

Sponsors

Jiangsu Province Hospital on Integration Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) All the selected cases were in accordance with the diagnostic criteria of adenocarcinoma of colon in the Chinese standard for diagnosis and treatment of common malignant tumors issued by the Ministry of health, and were confirmed by pathology; 2) All patients were treated with adjuvant chemotherapy after radical resection of colon cancer. The chemotherapy regimen was FOLFOX4, mFOLFOX6 or XELOX. Oxaliplatin was used 85mg/m2 once every two weeks (8-12 times); 3) The predicted survival time was more than 6 months; 4) Aged >= 18 years; 5) No severe damage to the center of gravity, liver, kidney or hematopoietic system.

Exclusion criteria

Exclusion criteria: 1) At present, there are any grade of peripheral neuropathy; 2) Having previously received chemotherapy drugs with neurotoxicity, such as oxaliplatin, cisplatin, taxanes or vinblastine alkaloids; 3) We are receiving carbamazepine, phenytoin sodium, valproate sodium, gabapentin, pregabalin, venlafaxine, norvenlafaxine, minapram, duloxetine, tricyclic antidepressants and other drugs that may have therapeutic or preventive effects on neuropathy; 4) Participate in any other clinical study; 5) There is a family history of hereditary/familial neuropathy. 6) Patients who can't take medicine orally; 7) Patients with mental illness who cannot cooperate; 8) Pregnant women.

Design outcomes

Primary

MeasureTime frame
EORTC QLQ-CIPN20;NCI-CTCAE 4.0;

Secondary

MeasureTime frame
Peripheral blood was used to detect neurotoxicity related indexes, such as TNF a and NGF;Evaluation of chemotherapy efficacy (RESIST 1.1);Number of chemotherapy cycles completed;EORTC QLQ-C30;

Countries

China

Contacts

Public ContactJiege Huo

Jiangsu Province Hospital on Integration Chinese and Western Medicine

hjg16688@163.com+86 15312019156

Outcome results

None listed

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