Trials / Terminated
TerminatedNCT02560740
A Study of the Efficacy and Safety of PerOx Quench on the Prevention of Oxaliplatin Treatment Induced Neuropathy
A Randomised, Double-blinded, Placebo Controlled Study to Assess the Efficacy and Safety of PerOx Quench or Placebo for 35 Days on the Prevention of Oxaliplatin Treatment Induced Sensory Neuropathy
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- SMR Biotech Co., Ltd. · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and often irreversible condition featuring pain, numbness, tingling and sensitivity to cold in the hands and feet (sometimes progressing to the arms and legs) that afflicts between 30 and 40 percent of patients undergoing chemotherapy. American Society of Clinical Oncology (ASCO) guidance on The Journal of Clinical Oncology (JCO, 2014 April 14) does not recommend any prophylaxis regimen for CIPN. PerOx Quench has unique membrane protection and anti-oxidative function as a special food, that's why to try to explore its preventive effects on CIPN prevention induced by Oxaliplatin for colorectal cancer or gastric cancer chemotherapy.
Detailed description
This study uses two stage group-sequential sampling design, based on current data, assumed the CIPN incidence rate is 50% in placebo arm, while 20% in PerOx Quench arm（60% reduction）, set a=0.05，80％ power, random allocation ratio is 1:1, obtained the subjects number is 41（total 82) by PASS 11 software for superior design; considering 10% drop out rate, final number of subjects totally is 90.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | PerOx Quench | By 1 week pretreatment of PerOx Quench and following 4 weeks taken to decrease the CIPN incidence. |
| DIETARY_SUPPLEMENT | PerOx Quench Placebo | By 1 week pretreatment of Placebo and following 4 weeks taken to record the CIPN incidence. |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2016-11-01
- Completion
- 2016-11-01
- First posted
- 2015-09-25
- Last updated
- 2016-12-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02560740. Inclusion in this directory is not an endorsement.