Overview

Effect of Vitamin C and E in Breast Cancer Patients Undergoing Chemotherapy

Status:
Recruiting
Trial end date:
2020-09-15
Target enrollment:
0
Participant gender:
Female
Summary
Title: Effect of Vitamin C and Vitamin E in Breast Cancer patients undergoing Chemotherapy. Purpose of the study: The present study has been designed to assess the effects of vitamin C and vitamin E superimposed upon chemotherapeutic agents where the antioxidant vitamin C and vitamin E would be concurrently applied to breast cancer patients. Method: The study would be a quasi-experimental study involving breast cancer patients and would be conducted in the Department of Pharmacology and Department of Oncology, BSMMU, from March 2019 to August 2020. A total of 80 breast cancer patients would be selected by abiding selective inclusion and exclusion criteria. After completing necessary formalities including informed written consent of the patients, patient's requisite data will be collected. The diagnosed patients would be randomly allocated into two groups: group A (control group) and group B (intervention group). Group A would consist of 40 patients who will receive chemotherapy and group B would consist of 40 patients who will receive vitamin C (1000 mg) and vitamin E (400 mg) orally daily along with chemotherapy. Both groups would receive treatment for 8 weeks. Comparison between the two groups would be performed through biochemical parameters such as total antioxidant capacity (TAC) and total oxidant status (TOS) at baseline (before vitamin C and vitamin E supplementation) and 6 weeks after intervention by vitamin C and E supplementationtation. Ethical consideration: The study will follow the principles of the Declaration of Helsinki and the World Medical Assembly. Patients will be informed about the study in easy language and then informed consent will be taken. This study has no potential risk to the patients. Confidentiality will be strictly maintained.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Treatments:
Ascorbic Acid
Vitamin E
Vitamins
Criteria
Inclusion Criteria:

- Breast cancer patient before starting chemotherapy and will agree to take protocol
based chemotherapy.

- Age: 30-70 years.

- Gender: Female.

Exclusion Criteria:

- Patients receiving chemotherapy prior to attend the Department of Oncology, BSMMU.

- Users of any antioxidant nutrient (e g. vitamin A, vitamin C or vitamin E) which can
interfere with concentration of endogenous antioxidant estimation.

- Patients with impaired renal and hepatic function.

- Patients with systemic illness such as diabetes, hypertension.

- Presence of any malignancy other than breast cancer.

- Mentally sick patient.

- Smoker.

- Patient suffering from alcohol or substance abuse or dependence.