Conditions: Pain Peripheral Neuropathy Neuropathic Pain
Keywords: Pain Puffer fish Tetrodotoxin TTX Neuropathy Chemotherapy WEX Pharmaceuticals
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 125
Healthy volunteers: no

Brief summary:
Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of many chemotherapeutic agents including vincristine, paclitaxel, cisplatin, oxaliplatin, bortezomib and ixabepilone. Chemotherapy-induced peripheral neuropathy commonly occurs in greater than 40% of patients. To improve the peripheral neuropathy, the chemotherapy dosing is often either decreased or discontinued potentially affecting tumor responsiveness, prognosis, and survival.

There is an unmet medical need for treatment of cancer patients with chemotherapy induced neuropathic pain (CINP) and the proposed study will investigate the efficacy and safety of multiple dose levels of tetrodotoxin (TTX) versus placebo in moderate to severe neuropathic pain caused by chemotherapy.

Detailed description:

Arms:
arm 1: Placebo for injection (1 ml volume), twice a day for four consecutive days. arm 2: Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days. arm 3: Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days. arm 4: Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days. arm 5: Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.

Interventions: intervention 1: Placebo intervention 2: Tetrodotoxin
Intervention descriptions: intervention 1: Sham treatment acting as control arm intervention 2: Comparison of different dosages of Tetrodotoxin

Protocol document: