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Tongluohuoxue Formula in the Prevention and Management of Paclitaxel-induced Peripheral Neuropathy: a Multicenter, Double-blind, Placebo-controlled Trial

Tongluohuoxue Formula in the Prevention and Management of Paclitaxel-induced Peripheral Neuropathy: a Multicenter, Double-blind, Placebo-controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083563
Enrollment
Unknown
Registered
2024-04-28
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Chemotherapy-associated peripheral neurotoxicity of erythroxylanes

Interventions

Test group: Tongluohuoxue Formula:From the first day of paclitaxel-based chemotherapy, patients should receive Tongluohuoxue Formula at the same time. 2 sachets should be used each time, and the solut
Control group: Tongluohuoxue placebo:From the first day of paclitaxel-based chemotherapy, patients should receive Tongluohuoxue Formula placebo at the same time. 2 sachets should be used each time, an

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age =18 years old, male and female are not limited. 2. Able to cooperate with the completion of the scale and follow-up visits 3. Patients with malignant tumors who are scheduled to receive chemotherapy with violet alkanes and have not yet received it.

Exclusion criteria

Exclusion criteria: 1. Those with a history of compression-induced neuropathy (e.g., carpal/tarsal tunnel syndrome, neuropathy, spinal stenosis, brachial plexus neuropathy) 2. Patients with diabetes and peripheral vascular disease 3. Patients with brain or meningeal metastases 4. Patients with significant hepatic and renal abnormalities 5. Patients with previously diagnosed neurological lesions. 6. Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
FACT-Ntx subscale;

Secondary

MeasureTime frame
NCI-CTCAE Classification;EORTC QLQ-CIPN20 scale;

Countries

China

Contacts

Public ContactLizhu Lin

Lingnan Cancer Institute, The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

gzucmlinlz@163.com+86 135 0150 5588

Outcome results

None listed

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