Evaluation of the therapeutic effects of livergol (silymarin) on the neuropathy caused by chemotherapy drugs (cisplatin, oxaliplatin and paclitaxel) in patients admitted to Education & Treatment Center of Valiasr.
Evaluation of the therapeutic effects of livergol (silymarin) on the neuropathy caused by chemotherapy drugs (cisplatin, oxaliplatin and paclitaxel)
Design
Randomized double blind clinical trial with intervention and placebo (single center)
Settings and conduct
In this randomized clinical trial (RCT) study, 70 patients with cancer who will receive either taxol or cisplatin and oxaliplatin-based chemotherapy regimens will be studied. First, the tibial, peroneal, and sural nerves will be evaluated by a neurologist for the severity of the involvement and the presence of neuropathy. Patients will be randomly divided into four groups using randomized blocks of four: one group will receive one daily Liverpool tablet (containing 1 mg silicarin for three months) along with chemotherapy regimen, and the second group will receive placebo. They will receive chemotherapy regimens. Electrophysiological status (including amplitude, latency, cv of the tibial, perianal and sural nerves) and subjective reporting of symptoms before and after treatment and three months after treatment will be compared between the two groups.
Participants/Inclusion and exclusion criteria
Entry requirements
1) Age range 40-75 years
2) Patients with cancers receiving oxaliplatin, cisplatin or paclitaxel-based chemotherapy regimens
3) Patients with concussions admitted to Valiasr educational center or referred to Valiasr Oncology Clinic
Exit conditions
1)En Liverpool contraindication
2)The presence of peripheral peripheral neuropathy continues to be the treatment that needs to be changed with chemotherapy regimens
3) Other underlying etiologies of neuropathy
Intervention groups
Intervention group received livergol tablet (140mg) once a day for three months; control group received placebo once a day for three months.
Main outcome variables
Quality of life, treatment efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190427043389N3
Registration date:2020-02-01, 1398/11/12
Registration timing:prospective
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Hamed Ghavimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 3635
Email address
ghavimih@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effects of livergol (silymarin) on the neuropathy caused by chemotherapy drugs (cisplatin, oxaliplatin and paclitaxel) in patients admitted to Education & Treatment Center of Valiasr.
Public title
Evaluation of the therapeutic effects of livergol (silymarin) on the neuropathy caused by chemotherapy drugs.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 35-75 years
Patients with cancers receiving oxaliplatin, cisplatin or paclitaxel-based chemotherapy regimens
Patients with concussions admitted to Valiasr educational center or referred to Valiasr Oncology Clinic
Exclusion criteria:
Liverpool contraindication
The presence of peripheral peripheral neuropathy continues to be the treatment that needs to be changed with chemotherapy regimens
Other underlying etiologies of neuropathy
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization with each block size is four.
Blinding (investigator's opinion)
Double blinded
Blinding description
The clinical trial will be planned in such a way that the participant and the clinical caregiver do not know which of the two control or test groups belongs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences