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Trial Title:
Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer
NCT ID:
NCT06642441
Condition:
Vitamin D
Chemotherapy
Breast Cancer
Adverse Reaction
Conditions: Official terms:
Breast Neoplasms
Vitamin D
Ergocalciferols
Conditions: Keywords:
Vitamin D
Breast Cancer
Adverse Reaction
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chemotherapy + vitamin D2
Description:
Before the start of treatment and every 3 weeks thereafter, participants will receive a
10 mg dose of vitamin D2 injection until adjuvant chemotherapy is completed. They will
receive a standard adjuvant chemotherapy regimen, which includes 10 mg of vitamin D2
injections per cycle during treatment. The dosage of adjuvant chemotherapy drugs can be
customized according to the clinical judgment of the doctor.
Arm group label:
Chemotherapy + vitamin D2
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Participants will receive a standard adjuvant chemotherapy treatment regimen for each
adjuvant chemotherapy cycle. The dosage of adjuvant chemotherapy drugs can be customized
according to the clinical judgment of the doctor.
Arm group label:
chemotherapy
Summary:
This randomized controlled Phase III trial was designed to evaluate the effect of vitamin
D supplementation (VD) on chemotherapy side effects following adjuvant chemotherapy in
breast cancer
Detailed description:
This is a parallel group, open-label randomized controlled trial to investigate the
occurrence of side effects of vitamin D supplementation (VD) in adjuvant chemotherapy in
patients with breast cancer. Both groups will receive standard adjuvant chemotherapy on
day 1 and each subsequent cycle. In addition, vitamin D2 will be given randomly to both
groups. Blood samples and imaging results were collected and analyzed before initiation
of adjuvant chemotherapy and after every two cycles. The primary outcome to be documented
was associated grade III or higher adverse events during adjuvant chemotherapy. Primary
and secondary study findings and adverse events will be thoroughly evaluated.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG)
performance status of 0-2.
2. Primary diagnosis of breast cancer confirmed by preoperative pathological
examination.
3. Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L).
4. Patients who have not previously received chemotherapy and who plan to undergo at
least 4 cycles of
5. Patients with adjuvant chemotherapy or combined targeted therapy.
6. Life expectancy of at least 6 months.
7. No other uncontrolled benign diseases at the time of recruitment.
8. All patients must have complete clinical medical records.
9. Willingness to voluntarily sign an informed consent form.
Exclusion Criteria:
1. History of invasive breast cancer.
2. Prior systemic treatment for the treatment or prevention of breast cancer.
3. Known allergic reactions to vitamin D or calcium compounds.
4. Comorbidities that may affect vitamin D or calcium balance or bone health.
5. Vitamin D or calcium supplementation in the past 3 months.
6. Presence of other tumors.
7. Pregnant or lactating women.
8. Individuals who do not wish to participate in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qinghai University Affiliated Hospital
Address:
City:
Xining
Zip:
810000
Country:
China
Contact:
Last name:
Jiuda Zhao, Dr
Phone:
869716230893
Email:
jiudazhao@126.com
Start date:
October 18, 2024
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Jiuda Zhao
Agency class:
Other
Source:
Affiliated Hospital of Qinghai University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06642441
