Study of Intradermal IncobotulinumtoxinA Injections for Treating Chemotherapy Induced Peripheral Neuropathy in Breast Cancer Patients

What this Trial Is About

Researchers are evaluating the safety and effectiveness of intradermal IncobotulinumtoxinA INA injections to treat chemotherapy induced peripheral neuropathy CIPN in breast cancer patients. CIPN is a common side effect of taxane and platinum-based chemotherapy that causes nerve pain and can affect quality of life and treatment continuation. The study aims to compare the pain relief from INA injections to placebo saline injections in patients who have developed neuropathic pain after chemotherapy. The study involves 40 breast cancer patients with CIPN confirmed by nerve conduction studies and neuropathic pain scale scores. Participants will be randomly assigned to receive either intradermal INA injections or saline placebo injections in the hands or feet where pain is reported. The treatment consists of 50 units of INA or equivalent saline volume injected across 50 sites per participant 25 per limb using a fine needle. The injections are given once, and the study follows patients for 6 months after intervention. Participants will have baseline and follow-up assessments including neuropathic pain scale NPS and quality of life questionnaires at 2, 4, 8, 12 weeks, and 6 months post-injection. Nerve conduction studies will confirm neuropathy before treatment. The study will monitor pain changes, quality of life impact, and any treatment-related side effects. Participants will attend clinic visits for testing and injection and may complete surveys by phone or online during follow-up. The primary outcome is pain improvement at 8 weeks measured by NPS scores.

Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy