NCT02590367

Estimate the Efficacy of HD6610 Granule for Oxaliplatin-induced Peripheral Neuropathy

Huo JieGe, Doctor of Medicine,Professor of Medicine,Professor of Medical Science.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Jiangsu Province Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate the usefulness and safety of HD6610 granule for oxaliplatin-induced peripheral neuropathy. The investigators examined the efficacy and safety of the treatment algorithm for 64 patients with colorectal cancer by evaluating the side effects and degree of improvement of subjective symptoms.

Detailed description

Oxaliplatin is the third generation platinum-based cytotoxic agent, widely used in colorectal cancer, in metastatic disease and in the adjuvant setting . Moreover, oxaliplatin is being used as an alternative option to cisplatin in various cancers, such as ovarian, gastric. Oxaliplatin-induced peripheral neuropathy is characterised by acute and transient cold hyperaesthesia in the hours and days following oxaliplatin infusion (\>90% of patients), but also by retarded chronic neuropathy due to the repetition of chemotherapy cycles (30-50% of patients). Oxaliplatin-induced peripheral neuropathy impairs the health-related quality of life (HRQOL) of patients and no preventive or curative strategies have as yet proven effective so far. Animal experiment show that HD6610 granule can relieve mouse's peripheral neuropathy induced by oxaliplatin. In clinical practice, the investigators also find that HD6610 granule can relieve patient's oxaliplatin-induced peripheral neuropathy in the treatment of chemotherapy. So the investigators design this randomized, parallel-group, double-blind, placebo-controlled, multicenter clinical study to estimate the efficacy and safety of HD6610 granule for oxaliplatin-induced peripheral neuropathy in colorectal cancer.

Conditions

• Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	FOLFOX regimen	FOLFOX regimens are combination therapy of oxaliplatin (85 mg/m\^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m\^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m\^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (different dose like FOLFOX4/FOLFOX6) via ambulatory pump administered for a period of 46 to 48 hours. XELOX is a combination therapy of Oxaliplatin 130mg/ m\^2 d1 Intravenous infusion, every 3 weeks. and Capecitabine 1000mg/m\^2 bid, days 1-14, every 3 weeks.
DRUG	HD6610 Granule	the HD6610 Granule will be given 2 times a day.
DRUG	HD6610 Granule placebo	the HD6610 Granule placebo will be given 2 times a day.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2015-10-29
• Last updated: 2015-12-02

Locations

1 site across 1 country: China