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

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02590367
• Other study ID #: JiangsuPHTCM
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 14, 2015
• Last updated: November 30, 2015
• Start date: August 2015
• Est. completion date: October 2017

Study information

• Verified date: November 2015
• Source: Jiangsu Province Hospital of Traditional Chinese Medicine
• Contact: Huo JieGe, M.D.
• Phone: +86 02585637121
• Email: hjg16688[@]126.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Exclusion Criteria:

1. Not accordant with the inclusion criteria;

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

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

Locations

Country	Name	City	State
China	Jiangsu Province Hospital of Integrated Chinese and Western Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Province Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

Balayssac D, Ferrier J, Pereira B, Gillet B, Pétorin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with different degree of peripheral nerve toxicity.		Through study completion, an average of 1 year.	Yes
Secondary	EORTC(European Organization for Research and Treatment of Cancer) quality of life score		Through study completion, an average of 1 year.	Yes
Secondary	KPS( Karnofsky Performance Status Scale) score		Through study completion, an average of 1 year.	Yes