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A randomized controlled clinical study to evaluate the efficacy and safety of ultrasound-guided neurotropin injection in the treatment of chemotherapy-induced peripheral neuropathy

A randomized controlled clinical study to evaluate the efficacy and safety of ultrasound-guided neurotropin injection in the treatment of chemotherapy-induced peripheral neuropathy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093142
Enrollment
Unknown
Registered
2024-11-29
Start date
2024-10-18
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

CIPN

Interventions

Control Group:Inject 6 ml sodium chloride
Experimental group:Injection 6 ml neurotropin

Sponsors

The Sixth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-80 years old; (2) Patients who have been diagnosed with colorectal cancer and have completed all chemotherapy treatment for at least 1 month; (3) Patients diagnosed with post-chemotherapy peripheral neuropathy by diagnostic criteria (>= grade 2); (4) Numbness score (VAS score) >=4 points; (5) Expected survival period >12 months; (6) without limb transfer; (7) No contraindications to the regimen of therapeutic drugs and neurotropin; (8) No long-term history of smoking or drinking; (9) Voluntarily participate in this experiment and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Accompanied by primary neuropathy; (2) previous diabetes, stroke, metabolic and other basic diseases; (3) There are cognitive disorders, serious infectious diseases, and abnormal coagulation function; (4) Patients with infection or other contraindications at the injection site; (5) Patients with neuroparesthesia due to nerve compression caused by tumor metastasis; (6) Severe depression and anxiety detected by psychological scale; (7) Patients with incomplete collection of evaluation index data affecting efficacy judgment; (8) Patients who voluntarily withdrew from the study.

Design outcomes

Primary

MeasureTime frame
Peripheral nerve numbness VAS score;Sensory nerve conduction velocity of peripheral nerve;

Secondary

MeasureTime frame
EORTC QLQ-CIPN20, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CIPN twenty-item scale;EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, thirty-item scale;Karnofsky, KPS;PHQ-9, Patient Health Questionnaire-9;Adverse events;CSA, cross section area;Cross-sectional area variation rate (injury and the injury of the cross-sectional area ratio);

Countries

China

Contacts

Public ContactWenjie Hu

The Sixth Affiliated Hospital of Sun Yat-sen University

huwenjie1205@163.com+86 156 2648 3084

Outcome results

None listed

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