Estimate the Efficacy of HD6610 Granule for Oxaliplatin-induced Peripheral Neuropathy
Huo JieGe, Doctor of Medicine,Professor of Medicine,Professor of Medical Science.
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 14, 2015
CompletedFirst Posted
Study publicly available on registry
October 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedDecember 2, 2015
November 1, 2015
2.2 years
September 14, 2015
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of patients with different degree of peripheral nerve toxicity.
Through study completion, an average of 1 year.
Secondary Outcomes (2)
EORTC（European Organization for Research and Treatment of Cancer） quality of life score
Through study completion, an average of 1 year.
KPS（ Karnofsky Performance Status Scale） score
Through study completion, an average of 1 year.
Study Arms (2)
FOLFOX regimen&HD6610 Granule
EXPERIMENTALPatients 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.
FOLFOX regimen&HD6610 Granule placebo
PLACEBO COMPARATORPatients in this group will be given conventional oxaliplatin based chemotherapy recommended by treatment guidelines for colorectal cancer, and the placebo HD6610 Granule
Interventions
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.
the HD6610 Granule placebo will be given 2 times a day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangsu Province Hospital of Integrated Chinese and Western Medicine
Nanjing, Jiangsu, 210028, China
Related Publications (1)
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.
PMID: 25833669BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Huo JieGe, M.D.
Jiangsu Province Hospital of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Huo JieGe, Doctor of Medicine,Professor of Medicine,Professor of Medical Science.
Study Record Dates
First Submitted
September 14, 2015
First Posted
October 29, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
December 2, 2015
Record last verified: 2015-11