Effect of Vitamin C and E in Breast Cancer Patients Undergoing Chemotherapy
Status:
Recruiting
Trial end date:
2020-09-15
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh