Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

• Primary diagnosis of breast cancer confirmed by preoperative pathological examination.

• Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L).

• Patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of

• Patients with adjuvant chemotherapy or combined targeted therapy.

• Life expectancy of at least 6 months.

• No other uncontrolled benign diseases at the time of recruitment.

• All patients must have complete clinical medical records.

• Willingness to voluntarily sign an informed consent form.

Locations
Other Locations
China
Qinghai University Affiliated Hospital
RECRUITING
Xining
Qinghai University Affiliated Hospital
NOT_YET_RECRUITING
Xining
Contact Information
Primary
Jiuda Zhao
jiudazhao@126.com
869716230893
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 100
Treatments
Experimental: Chemotherapy + vitamin D2
Before the start of treatment and every 3 weeks thereafter, participants will receive a 10-milligram 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.
Other: chemotherapy
Participants will receive a standard adjuvant chemotherapy regimen for each adjuvant chemotherapy cycle. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.
Related Therapeutic Areas
Sponsors
Leads: Jiuda Zhao

This content was sourced from clinicaltrials.gov