Effect of Melatonin on arthralgia-myalgia of Paclitaxel

Phase 3

Recruiting

Conditions: Breast cancer.
Malignant neoplasm of breast

Registration Number: IRCT20190630044057N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 62

Inclusion Criteria

Women with Breast Cancer and Candidate receiving Paclitaxel 80 mg / m 2 weekly for 12 weeks after doxorubicin + cyclophosphamide regimen
Age over 18 years
Ability to take oral medication
Ability to fill out a questionnaire
Not taking pain relief medication for chronic
No peripheral neuropathy
No history of fibromyalgia, Rheumatoid arthritis, Osteoarthritis
No history of receiving paclitaxel or any other drug with neurotoxicity
Uncontrolled diabetes
no history of receiving alcohol, statin, colchicine, zidovudine, penicillamine.
no history of metastatic disease

Exclusion Criteria

Patients with concurrent GCSF administration
Patients who experience trauma or falling during the study
Viral Respiratory Infection During Study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arthralgia. Timepoint: Arthralgia before Paclitaxel administration and daily after. Method of measurement: Brief Pain Inventory (BPI) and National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE).;Myalgia. Timepoint: Myalgia before Paclitaxel administration and daily after. Method of measurement: Brief Pain Inventory (BPI) and National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE).;Neuropathy. Timepoint: neuropathy before Paclitaxel administration and weekly after. Method of measurement: Douleur Neuropathique 4 Questions (DN4) and National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE).

Secondary Outcome Measures