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

Primary Purpose

Peripheral Neuropathy

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

FOLFOX regimen

HD6610 Granule

HD6610 Granule placebo

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring oxaliplatin-induced peripheral neuropathy, HD6610 granule, colorectal cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All cases have been diagnosed with colorectal cancer by pathology;
Patients who received no chemotherapy before should receive oxaliplatin-based chemotherapy(FOLFOX4,FOLFOX6,XELOX) ;
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;
Patients with no positive sign in neurological examination,and no drug allergy history or diabetes;
Volunteered to participate and signed informed consent,patients can not receive radiotherapy,acupuncture and moxibustion or other treatment during the experiment.

Exclusion Criteria:

Not accordant with the inclusion criteria;
Patients who have used herbal within 4 weeks before registration;
Patients who have serious heart,liver,kidney and hematopoietic disfunction;
Patients of central nervous system disease;
Patients of cervical spondylopathy,lumbar disc protrusion,diabetes and uremia which can potentially cause peripheral neuropathy;
Nerve compression caused by tumor metastasis or peripheral neuropathy caused by electrolyte disturbances,diabetes,alcohol disease and other disorder;
Long-time using of thiazide diuretic and foxglove;
Patients of poisoning,infection and radiotherapy which induced peripheral neuropathy or receiving medicine which can cause peripheral neuropathy;
Patients who can hardly take Chinese Medicine with severe diarrhea,vomiting or intestinal obstruction ;
Uncontrolled psychosis;
Women of pregnancy ,preparing pregnant, or lactation;
Alcohol and drug abuse;
Allergic constitution or allergy to experiment drugs.

Sites / Locations

Jiangsu Province Hospital of Integrated Chinese and Western MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FOLFOX regimen&HD6610 Granule

FOLFOX regimen&HD6610 Granule placebo

Arm Description

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

Outcomes

Primary Outcome Measures

The number of patients with different degree of peripheral nerve toxicity.

Secondary Outcome Measures

EORTC（European Organization for Research and Treatment of Cancer） quality of life score

KPS（ Karnofsky Performance Status Scale） score

Full Information

NCT ID

NCT02590367

First Posted

September 14, 2015

Last Updated

November 30, 2015

Sponsor

Jiangsu Province Hospital of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02590367

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 Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jiangsu Province Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Neuropathy

Keywords

oxaliplatin-induced peripheral neuropathy, HD6610 granule, colorectal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FOLFOX regimen&HD6610 Granule

Arm Type

Experimental

Arm Description

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.

Arm Title

FOLFOX regimen&HD6610 Granule placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

FOLFOX regimen

Other Intervention Name(s)

XELOX

Intervention Description

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

Intervention Name(s)

HD6610 Granule

Intervention Description

the HD6610 Granule will be given 2 times a day.

Intervention Type

Drug

Intervention Name(s)

HD6610 Granule placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

The number of patients with different degree of peripheral nerve toxicity.

Time Frame

Through study completion, an average of 1 year.

Secondary Outcome Measure Information:

Title

EORTC（European Organization for Research and Treatment of Cancer） quality of life score

Time Frame

Through study completion, an average of 1 year.

Title

KPS（ Karnofsky Performance Status Scale） score

Time Frame

Through study completion, an average of 1 year.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All cases have been diagnosed with colorectal cancer by pathology; Patients who received no chemotherapy before should receive oxaliplatin-based chemotherapy(FOLFOX4,FOLFOX6,XELOX) ; 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; Patients with no positive sign in neurological examination,and no drug allergy history or diabetes; Volunteered to participate and signed informed consent,patients can not receive radiotherapy,acupuncture and moxibustion or other treatment during the experiment. Exclusion Criteria: Not accordant with the inclusion criteria; Patients who have used herbal within 4 weeks before registration; Patients who have serious heart,liver,kidney and hematopoietic disfunction; Patients of central nervous system disease; Patients of cervical spondylopathy,lumbar disc protrusion,diabetes and uremia which can potentially cause peripheral neuropathy; Nerve compression caused by tumor metastasis or peripheral neuropathy caused by electrolyte disturbances,diabetes,alcohol disease and other disorder; Long-time using of thiazide diuretic and foxglove; Patients of poisoning,infection and radiotherapy which induced peripheral neuropathy or receiving medicine which can cause peripheral neuropathy; Patients who can hardly take Chinese Medicine with severe diarrhea,vomiting or intestinal obstruction ; Uncontrolled psychosis; Women of pregnancy ,preparing pregnant, or lactation; Alcohol and drug abuse; Allergic constitution or allergy to experiment drugs.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huo JieGe, M.D.

Phone

+86 02585637121

hjg16688@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huo JieGe, M.D.

Organizational Affiliation

Jiangsu Province Hospital of Traditional Chinese Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Jiangsu Province Hospital of Integrated Chinese and Western Medicine

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210028

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huo Jie Ge, M.D.

Phone

+86 02585637121

hjg16688@126.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

25833669

Citation

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.

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

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