Evaluation the efficacy of extract of Dracocephalum in chemotherapy

Phase 3

Recruiting

• Conditions: Chemotherapy induced peripheral neuropathy.; Paraneoplastic neuromyopathy and neuropathy; G13.0

• Registration Number: IRCT20201128049515N2
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 May 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Patients with cancer between 18 to 75 years old
Patients who has received their first neurotoxic chemotherapy by using Vinca alkaloids, platinum and taxane derivatives.
Patients with neuropathy symptoms.

Exclusion Criteria

Other possible reasons for neuropathy (diabetes, thyroid function disorder, B12 deficiency, alcohol abuse)
Taking other medications for neuropathy symptoms simultaneously
Taking any type of anti oxidant supplements in recent two months
Pregnant or nursing women

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chemotherapy induced peripheral neuropathy. Timepoint: At initial assessment and 1,2 and 3 month after initial assessment. Method of measurement: Performance status- Eastern Cooperative Oncology Group questionnaire (PS-ECOG).

Secondary Outcome Measures

Name	Time	Method
The efficacy of treatment. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Evaluation of neuropathy symptom alleviation and questionnaire.;Pain intensity. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Based on visual analogue scale and questionnaire.;Adverse effects. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Common Terminology Criteria for Adverse Events and questionnaire.;Quality of life. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Questionnaire developed to assess the quality of life of cancer patients.