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

NCT04463459 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-07-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Vitamin C, Vitamin E

Vitamin C (500mg) twice daily and Vitamin E (400mg) once daily

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Principal Investigators

  • Fatisha Khanam, MBBS · BSMMU(Recruting), Dhaka-1000, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2020-07-20
Completion
2020-09-15

Countries

  • Bangladesh

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04463459 on ClinicalTrials.gov