Investigating the effect of chamomile oral solution on neurological complications caused by chemotherapy regimens containing paclitaxel in cancer patients.

Phase 3

Conditions: Various cancers treated by paclitaxel.
malignant neoplasms
C00-C97

Registration Number: IRCT20200408046990N14

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 40

Inclusion Criteria

Suffering from cancer and starting chemotherapy regimen containing paclitaxel at a dose of 175 mg/m2.
age between 18-70 yers

Exclusion Criteria

Liver failure (due to the change in drug clearance): If the ALT and AST tests are more than two to three times the normal level at the beginning of the treatment, the patient will be excluded from the study.
Renal failure (GFR<30 ml/min)
Neuropathy at baseline
Having diabetes or other disorders that cause neuropathy
Taking supplements containing antioxidant compounds
Use of neuromodulator drugs such as compounds containing calcium or magnesium and anticonvulsant drugs such as gabapentin and antidepressants from tricyclic antidepressants and serotonin-norepinephrine reuptake inhibitors.
Taking warfarin
alcohol consumption
Smoking
Lack of patient satisfaction
Having a history of allergy to chamomile
BMI>30
Use of other neurotoxic drugs in the chemotherapy regimen, such as platinums or vincristine
Suffering from concurrent neuromuscular diseases such as myasthenia gravis
Guillain Barre syndrome, multifocal motor neuropathy and chronic inflammatory demyelinating polyneuropathy

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
europathy. Timepoint: at baseline-after each course-at the end of study. Method of measurement: based on NCI-CTC (national cancer institute-common toxicity criteria version 5).

Secondary Outcome Measures

Name	Time	Method
Sleep assessment. Timepoint: at the beginning of study-at the end of study. Method of measurement: Based on the Pittsburgh Sleep Quality Index.;Assessment of anxiety. Timepoint: at the beginning of study-at the end of study. Method of measurement: Generalized Anxiety Disorder scale questionnaire index.