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

NCT ID: NCT02590367

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-10-31

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.

Conditions

Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

FOLFOX regimen&HD6610 Granule

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.

Group Type: EXPERIMENTAL

FOLFOX regimen

Intervention Type: DRUG

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.

HD6610 Granule

Intervention Type: DRUG

the HD6610 Granule will be given 2 times a day.

FOLFOX regimen&HD6610 Granule placebo

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

Group Type: PLACEBO_COMPARATOR

FOLFOX regimen

Intervention Type: DRUG

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.

HD6610 Granule placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

HD6610 Granule

the HD6610 Granule will be given 2 times a day.

Intervention Type: DRUG

HD6610 Granule placebo

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

Intervention Type: DRUG

Other Intervention Names

XELOX

Eligibility Criteria

Inclusion Criteria

1. All cases have been diagnosed with colorectal cancer by pathology;

2. Patients who received no chemotherapy before should receive oxaliplatin-based chemotherapy(FOLFOX4,FOLFOX6,XELOX) ;

3. Patients of 18-70 years old have no serious heart,liver,kidney and hematopoietic disfunction,life expectancy of over 3 months and KPS more than 60;

4. Patients with no positive sign in neurological examination,and no drug allergy history or diabetes;

5. Volunteered to participate and signed informed consent,patients can not receive radiotherapy,acupuncture and moxibustion or other treatment during the experiment.

2. Patients who have used herbal within 4 weeks before registration;

3. Patients who have serious heart,liver,kidney and hematopoietic disfunction;

4. Patients of central nervous system disease;

5. Patients of cervical spondylopathy,lumbar disc protrusion,diabetes and uremia which can potentially cause peripheral neuropathy;

6. Nerve compression caused by tumor metastasis or peripheral neuropathy caused by electrolyte disturbances,diabetes,alcohol disease and other disorder;

7. Long-time using of thiazide diuretic and foxglove;

8. Patients of poisoning,infection and radiotherapy which induced peripheral neuropathy or receiving medicine which can cause peripheral neuropathy;

9. Patients who can hardly take Chinese Medicine with severe diarrhea,vomiting or intestinal obstruction ;

10. Uncontrolled psychosis;

11. Women of pregnancy ,preparing pregnant, or lactation;

12. Alcohol and drug abuse;

13. Allergic constitution or allergy to experiment drugs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Province Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

JieGe Huo

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huo JieGe, M.D.

Role: STUDY_DIRECTOR

Jiangsu Province Hospital of Traditional Chinese Medicine

Locations

Jiangsu Province Hospital of Integrated Chinese and Western Medicine

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huo JieGe, M.D.

Role: CONTACT

hjg16688@126.com

+86 02585637121

Facility Contacts

Huo Jie Ge, M.D.

Role: primary

hjg16688@126.com

+86 02585637121

References

Balayssac D, Ferrier J, Pereira B, Gillet B, Petorin C, Vein J, Libert F, Eschalier A, Pezet D. Prevention of oxaliplatin-induced peripheral neuropathy by a polyamine-reduced diet-NEUROXAPOL: protocol of a prospective, randomised, controlled, single-blind and monocentric trial. BMJ Open. 2015 Apr 1;5(4):e007479. doi: 10.1136/bmjopen-2014-007479.

Reference Type: BACKGROUND

PMID: 25833669 (View on PubMed)

Other Identifiers

JiangsuPHTCM

Identifier Type: -

Identifier Source: org_study_id