Neuropathy is the major dose-limiting side effect of chemotherapeutic agents of paclitaxel and carboplatin. Ginger has anti-inflammatory, anti-oxidative and neuroprotective properties. The aim of this study is evaluating the prophylactic effect of ginger against chemotherapy-induced peripheral neuropathy. Inclusion criteria consist of suffering from ovarian or non-small cell lung cancer. Patients with history of other malignancies or degenerative neurological disorders will be excluded from the study. Accordingly, 52 patients will be enrolled in this study and they will be allocated randomly into supplemented group with 2 g daily ginger or corn starch placebo (2 one-gram tablets) during chemotherapy period for 18 weeks. Incidence and severity of CIPN will be assessed before the onset of and at the end of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121415780N1
Registration date:2014-03-15, 1392/12/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-15, 1392/12/24
Registrant information
Name
Zohreh Ghoreishi
Name of organization / entity
Nutrition Research Center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 2295
Email address
ghoreishiz@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Applied Drug Research Center, Nutrition Research Center, Physical Medicine & Rehabilitation Research Center, Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
Expected recruitment start date
2014-01-20, 1392/10/30
Expected recruitment end date
2015-07-11, 1394/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of ginger and corn starch effect on chemotherapy-induced neuropathy in patients with ovarian and lung cancer
Public title
Ginger effect on chemotherapy-induced neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria:suffering from ovarian cancer; non-small cell lung cancer; willingness to corporate. Exclusion Criteria:age more than 70 years; suffering from diabetes; AIDS;hyperthyroidism; primary neurological diseases; other kinds of malignancies; history of chemotherapy; consumption of vitamin; mineral or fish oil supplementation at list 3 months before the enrollment; Ginger sensitivity
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah St., Tabriz, Iran
City
Tabriz
Postal code
Approval date
2014-01-20, 1392/10/30
Ethics committee reference number
92172
Health conditions studied
1
Description of health condition studied
ovarian cancer
ICD-10 code
C56
ICD-10 code description
Malignant neoplasm of ovary
2
Description of health condition studied
lung cancer
ICD-10 code
C34
ICD-10 code description
Malignant neoplasm of bronchus and lung
Primary outcomes
1
Description
Incidence of chemotherapy-induced peripheral neuropathy
Timepoint
before the onset of chemotherapy and after 18 weeks, at the end of the treatment period
Method of measurement
rTNS Score, Nerve Conduction Studiy
2
Description
Severity of chemotherapy-induced peripheral neuropathy
Timepoint
before the onset of chemotherapy and after 18 weeks, at the end of the treatment period
Method of measurement
rTNS Score, Nerve Conduction Studiy
Secondary outcomes
1
Description
serum levels of pro-inflammatory cytokines
Timepoint
before the onset of chemotherapy and after 18 weeks at the end of treatment.
Method of measurement
ELISA
2
Description
Total Antioxidant Status (TAS)
Timepoint
before the onset of chemotherapy and after 18 weeks at the end of treatment.
Method of measurement
Spectrophotometry
3
Description
serum level of MDA
Timepoint
before the onset of chemotherapy and after 18 weeks at the end of treatment.
Method of measurement
Spectrophotometry
4
Description
activity of SOD & GPX enzymes in RBC
Timepoint
before the onset of chemotherapy and after 18 weeks at the end of treatment.
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Supplemented group: 2 g oral ginger daily( 2 one-gram tablets of ginger)for 18 weeks
Category
Prevention
2
Description
Placebo group: 2 g oral corn starch daily( 2 one-gram tablets of corn starch)for 18 weeks
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ward of Hematology & Oncology, Shahid Ghazi Hospital