Clinical study of IND02 on side effects of breast cancer chemotherapy

Not Applicable

Completed

• Conditions: Health Condition 1: L651- Anagen effluviumHealth Condition 2: null- Female Breast Cancer Patients under Chemotherapy

• Registration Number: CTRI/2012/08/002883
• Lead Sponsor: Indus Biotech Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-06-06
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

•Female patients between 18 years and 70 years of age.

•Patients with histologically or cytologically confirmed primary carcinoma of the breast by using core biopsy, needle biopsy or fine-needle aspiration cytology.

•Patients who have undergone mastectomy and with indications for Chemotherapy.

•Patients with Leucocyte count more than 4000/mm³.

•Patients with Platelet count more than 100,000/mm³.

•Patients with Hemoglobin more than 10.0 g/dL.

•Patients who are willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria

•Patients who have received prior Chemotherapy or hormonal therapy for the treatment of breast cancer within the last 6 months.

•Patients with existing Mucositis or oral and throat pain condition prior to starting Chemotherapy.

•Patient who have already shaved the scalp hair before receiving Chemotherapy.

•Patients known to have hypersensitivity to the study medication, its excipients, its analogs, or any of the components of herbs.

•Patients diagnosed with active sero-positive Acquired Immunodeficiency Syndrome (AIDS) or Hepatitis B/C.

•Pre-menopausal female patients who are pregnant, lactating or of child bearing potential and not on contraceptives.

•Patients with altered mental status precluding understanding of the informed consent process and/or completion of the necessary assessments.

•Patients with other severe diseases including abnormal cardiac conditions, hepatic or renal disorder, uncontrolled diabetes or other medical conditions that is likely to interfere with the study in the investigatorâ??s judgment.

•Patients who have participated in other cancer trials in the past 30 days.

•Patients who, in the investigatorâ??s clinical judgment, are not suitable for this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified