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Capecitabine

Leucovorin

Fluorouracil

Oxaliplatin

Patients in this group will be given conventional oxaliplatin based chemotherapy recommended by treatment guidelines for colorectal cancer, and the HD6610 Granule will be given 2 times a day.

Patients in this group will be given conventional oxaliplatin based chemotherapy recommended by treatment guidelines for colorectal cancer, and the placebo HD6610 Granule

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.

FOLFOX regimen

the HD6610 Granule will be given 2 times a day.

HD6610 Granule

the HD6610 Granule placebo will be given 2 times a day.

HD6610 Granule placebo

Huo JieGe, M.D.

Huo Jie Ge, M.D.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Estimate the Efficacy of HD6610 Granule for Oxaliplatin-induced Peripheral Neuropathy	NCT02590367	Peripheral Neur...	FOLFOX regimen HD6610 Granule HD6610 Granule ...	18 Years - 70 Years	Jiangsu Province Hospital of Traditional Chinese Medicine
Estimate the Efficacy of HD6610 Granule for Oxaliplatin-induced Peripheral Neuropathy	NCT02590367	Peripheral Neur...	FOLFOX regimen HD6610 Granule HD6610 Granule ...	18 Years - 70 Years	Jiangsu Province Hospital of Traditional Chinese Medicine

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