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

July 4, 2020 updated by: Dr. Fatisha Khanam, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is a devastating cancer having multifactorial origin. It is the most common cancer and second leading cause of death in women. Every year more than one million breast cancer patients are diagnosed throughout the world and it has been assumed that among them more than 410000 would die due to the disease. In our country due to the absence of official registry records, not much information about breast cancer. 12764 new cases of breast cancer were diagnosed and 6846 women died in Bangladesh in the year 2018. In low- and middle-income countries including Bangladesh due to lower resource settings women with breast cancer may receive inadequate treatment, palliative care or pain relief. 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. Statistical analysis will be obtained by SPSS (Statistical Package for Social Science) version 20. Results will be presented in tables and figures as applicable. Calculated 'P' value may suggest the level of significance (significant at P˂0.05, 0.01 and 0.001). 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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Chemotherapy + Placebo
Patients receiving chemotherapy This group will be received chemotherapy and placebo
Active Comparator: Chemotherapy + Vitamin C + Vitamin E
Patients receiving vitamin C and E with Chemotherapy This group will be received vitamin C (500 mg) twice daily and vitamin E (400 mg) once daily with chemotherapy for 6 weeks
Drug: Vitamin C, Vitamin E
Vitamin C (500mg) twice daily and Vitamin E (400mg) once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure the serum level of MDA and RBC glutathione in breast cancer patients receiving chemotherapy and following administration of vitamin C and vitamin E concurrent to chemotherapy.
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

  • Principal Investigator: Fatisha Khanam, MBBS, BSMMU(Recruting), Dhaka-1000, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2019

Primary Completion (Anticipated)

July 20, 2020

Study Completion (Anticipated)

September 15, 2020

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

July 4, 2020

First Posted (Actual)

July 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 4, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSMMU/2019/8874

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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