Clinical trial NCT02590367: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Peripheral Neuropathy
Keywords: oxaliplatin-induced peripheral neuropathy
HD6610 granule
colorectal cancer
Lead sponsor: Jiangsu Province Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: The number of patients with different degree of peripheral nerve toxicity.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: EORTC（European Organization for Research and Treatment of Cancer） quality of life score
timeFrame: Through study completion, an average of 1 year.
measure: KPS（ Karnofsky Performance Status Scale） score
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Integrated Chinese and Western Medicine
state: Jiangsu
Study officials:
affiliation: Jiangsu Province Hospital of Traditional Chinese Medicine
name: Huo JieGe, M.D.
role: STUDY_DIRECTOR
References:
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.