Breast CancerNCT04463459
Effect of Vitamin C and E in Breast Cancer Patients Undergoing Chemotherapy
A study testing Vitamin C, Vitamin E in people with Breast Cancer, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Vitamin C, Vitamin E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBangladesh
- Study dates
- 10 Oct 2019to 15 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patient before starting chemotherapy and will agree to take protocol based chemotherapy.
- Age: 30-70 years.
- Gender: Female.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
BSMMU
Dhaka
Fatisha Khanam, MBBS, 01675599917, fatisha.khanam@gmail.com
Amirul Pavel, MBBS, 01611118008, amirul.pavel@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Vitamin C, Vitamin E
- Keywords
- Vitamin C, Vitamin E, Breast cancer, Chemotherapy, MDA, RBC Glutathione
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C, Vitamin EDrug
Vitamin C (500mg) twice daily and Vitamin E (400mg) once daily
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + Placebo | No intervention | Patients receiving chemotherapy This group will be received chemotherapy and placebo |
| Chemotherapy + Vitamin C + Vitamin E | Active comparator | 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 Receives: Drug: Vitamin C, Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start10 Oct 2019
- Primary completion20 Jul 2020 (estimated)
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fatisha Khanam, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Fatisha Khanam, MBBS, Principal investigator, BSMMU(Recruting), Dhaka-1000, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463459
- Sponsor's protocol ID
- BSMMU/2019/8874
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin C and Vitamin E in Breast Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT04463459
- Acronym / sponsor ID
- BSMMU/2019/8874
- Conditions
- Breast Cancer
- Keywords
- Vitamin C, Vitamin E, Breast cancer, Chemotherapy, MDA, RBC Glutathione
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 20 Jul 2020 (estimated)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + Placebo | No intervention | –Patients receiving chemotherapy This group will be received chemotherapy and placebo |
| Chemotherapy + Vitamin C + Vitamin E | Active comparator | Drug: Vitamin C, Vitamin EPatients 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 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Breast cancer patient before starting chemotherapy and will agree to take protocol based chemotherapy.
- Age: 30-70 years.
- Gender: Female.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C, Vitamin EVitamin C (500mg) twice daily and Vitamin E (400mg) once daily | Drug | Chemotherapy + Vitamin C + Vitamin E |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatisha Khanam, MBBS principal investigator
BSMMU(Recruting), Dhaka-1000, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C, Vitamin E in people with Breast Cancer, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatisha Khanam, MBBS (01675599917, fatisha.khanam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.