Clinical trial · Interventional
Estimate the Efficacy of HD6610 Granule for Oxaliplatin-induced Peripheral Neuropathy
Huo JieGe, Doctor of Medicine,Professor of Medicine,Professor of Medical Science.
NCT02590367CI-TRIAL-00020007unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX regimen | Drug | FOLFOX Regimen | ALIAS |
| HD6610 Granule | Drug | — | UNRESOLVED |
| HD6610 Granule placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FOLFOX regimen&HD6610 Granule
- 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.
- interventionNames
- Drug: FOLFOX regimen
- Drug: HD6610 Granule
- type
- PLACEBO_COMPARATOR
- label
- FOLFOX regimen&HD6610 Granule placebo
- description
- Patients in this group will be given conventional oxaliplatin based chemotherapy recommended by treatment guidelines for colorectal cancer, and the placebo HD6610 Granule
- interventionNames
- Drug: FOLFOX regimen
- Drug: HD6610 Granule placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDBalayssac 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 25833669