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Investigation the effect of oral Rosemary extract on chemotherapy induced peripheral neuropathy

Phase 2
Recruiting
Conditions
chemotherapy induced peripheral neuropathy.
Registration Number
IRCT20200331046902N1
Lead Sponsor
Khoram-Abad University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
52
Inclusion Criteria

Patients with metastatic gastrointestinal cancers aged 25 to 80 years undergoing chemotherapy with oxaliplatin-containing chemotherapy regimens.

Exclusion Criteria

Patients who have previously received a chemotherapy regimen containing neurotoxic drugs and now have peripheral neuropathy.
Patients receiving other neurotoxic drugs (such as some HIV drugs) at the same time as chemotherapy.
Patients with a history of diabetes mellitus and peripheral neuropathy caused by nerve compression (such as carpal tunnel or tarsal syndrome, radiculopathy, spinal stenosis, brachial plexopathy)
Patients who, at the same time as chemotherapy, start taking drugs that reduce neuropathy symptoms (such as SNRI drugs) and pain relievers such as acetaminophen, pregabalin, and NSIDs, or change their amount during treatment.
Patients with psychological disorders such as: severe depression, patients with suicidal thoughts, bipolar diseases
Patients who consume alcohol.
Patients with significant impairment of liver and kidney tests
Patients who do not agree to consume rosemary extract or do not agree to participate in the study in any way.
The patient is unable to tolerate rosemary extract during the study.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Chemotherapy induced peripheral neuropathy. Timepoint: At the beginning of the study, and then before the start of each chemotherapy session for up to two months. Method of measurement: Based on the EORTC-CIPN20 questionnaire and measuring symptoms by a research expert based on the Total Neuropathy Score (TNS) scale.;Severity of neuropathic pain based on Numerical Rating Scale tool. Timepoint: At the beginning of the study, and then before the start of each chemotherapy session for up to two months. Method of measurement: Measurement of symptoms by an investigator based on the Numerical Rating Scale tool.
Secondary Outcome Measures
NameTimeMethod
Quality of life score. Timepoint: At the beginning of the study, and then before the start of each chemotherapy session for up to two months. Method of measurement: Based on the EORTC QLQ-C30 questionnaire.
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