Relationship between IL6 and fatigue induced by radiotherapy and chemotherapy in patients treated with Melatonin drug

Phase 3

Recruiting

• Conditions: Breast Cance; Cancer Related Fatigue; Melatonin; Interleukin 6.; Malignant neoplasm of breast

• Registration Number: IRCT20180426039421N2
• Lead Sponsor: Hamedan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 October 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

Breast Cancer Stages I, II, III According to Pathological Reports
Patients at least 18 Years Old
Have Signed a Written Consent
Recevieng Adjuvant Chemotherapy and Radiotherapy
No Untreated Hypercalcemia
No Systolic Blood Pressure Less Than 100 mm Hg
No Warfarin Consumption
No Methylphenidate Consumption
No Sleep Pills During Melatonin Use
No TSH>5/5 or <0/5
No Pregnancy or Breastfeeding

Exclusion Criteria

Expired During Treatment
Stop Using Melatonin during Treatment

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue severity in the BFI questionnaire. Timepoint: 4 weeks after last adjuvant treatment session. Method of measurement: Brief Fatigue Inventory( BFI) questionnaire.;IL6( interleukin 6) serum level. Timepoint: 4 weeks after last adjuvant treatment session. Method of measurement: Solid phase sandwich ELISA method.