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Trial Title:
Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients With Breast Cancer
NCT ID:
NCT06642428
Condition:
Vitamin D
Neoadjuvant Therapy
Breast Cancer
Adverse Reaction
Efficacy
Chemotherapy
Conditions: Official terms:
Breast Neoplasms
Vitamin D
Ergocalciferols
Conditions: Keywords:
Vitamin D
Breast Cancer
Adverse Reaction
Efficacy
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:
Neoadjuvant therapy + vitamin D2
Description:
Before the start of treatment and every 3 weeks thereafter, participants will receive
injections of vitamin D2 at a dosage of 10 mg until the completion of neoadjuvant
therapy. They will undergo the standard neoadjuvant regimen, which includes the 10 mg
injection of vitamin D2 per cycle during the therapy. The dosage of neoadjuvant drugs may
be tailored based on the physician's clinical judgment.
Arm group label:
Neoadjuvant therapy + vitamin D2
Intervention type:
Drug
Intervention name:
Neoadjuvant therapy
Description:
Participants will receive the standard neoadjuvant regimen during each cycle of
neoadjuvant therapy. The dosage of the neoadjuvant drugs may be tailored based on the
physician's clinical judgment.
Arm group label:
Neoadjuvant therapy
Summary:
This randomized controlled Phase III trial was designed to evaluate the impact of
supplemental vitamin D (VD) on the efficacy and side effects of neoadjuvant therapy in
patients with breast cancer.
Detailed description:
This is a parallel-group, open-label randomized controlled trial designed to investigate
the effects of supplemental vitamin D (VD) on the outcomes and side effects of
neoadjuvant therapy in patients with breast cancer. Both groups will receive standard
neoadjuvant therapy on day 1 and for each subsequent cycle. Additionally, vitamin D2 will
be randomly administered to both groups.Blood samples and imaging results will be
collected and analyzed prior to the initiation of neoadjuvant therapy and after every two
cycles. Key outcomes to be recorded include the pathological complete response rate
(pCR), objective response rate (ORR), disease control rate (DCR), and grade III or higher
adverse effects related to neoadjuvant therapy. The primary and secondary study findings,
along with 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.neoadjuvant 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 15, 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/NCT06642428
