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Spots Global Cancer Trial Database for Estimate the Efficacy of HD6610 Granule for Oxaliplatin-induced Peripheral Neuropathy

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Trial Identification

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

Official Title: Huo JieGe, Doctor of Medicine,Professor of Medicine,Professor of Medical Science.

Study ID: NCT02590367

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Jiangsu Province Hospital of Integrated Chinese and Western Medicine, Nanjing, Jiangsu, China

Contact Details

Name: Huo JieGe, M.D.

Affiliation: Jiangsu Province Hospital of Traditional Chinese Medicine

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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