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

NCT02590367 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2015-12-02

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Jiangsu Province Hospital of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Huo JieGe, M.D. · Jiangsu Province Hospital of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02590367 on ClinicalTrials.gov