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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Chemotherapy; Vitamin D; Adverse Reaction
• Intervention / Treatment: Drug: Chemotherapy + vitamin D2; Drug: Chemotherapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiuda Zhao; Phone Number: 869716230893; Email: jiudazhao@126.com

Study Locations

• China
  • Qinghai
    • Xining, Qinghai, China, 810000
      • Recruiting
      • Qinghai University Affiliated Hospital
    • Xining, Qinghai, China, 810000
      • Not yet recruiting
      • Qinghai University Affiliated Hospital
      • Contact: Jiuda Zhao, Dr; Phone Number: 869716230893; Email: jiudazhao@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Chemotherapy + vitamin D2; 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.
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.	Drug: Chemotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and proportion of treatment-related adverse events	The occurrence of side effects between the two groups from the first to the last chemotherapy	4-6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of side effects associated with adjuvant therapy (CTCAE v5.0)	Side effects of adjuvant therapy were evaluated according to CTCAE v5.0 criteria. CTCAE v5.0 was used to evaluate the degree of adverse events after patients received adjuvant chemotherapy. The level of adverse events was divided into 1-5 grades. The higher the level, the more serious the degree of adverse reactions after patients received chemotherapy, and active intervention was required.	From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.
Assessment of side effects associated with adjuvant therapy (EQ-5D Health Status Scale)	Side effects of adjuvant therapy will be assessed according to the EQ-5D Health Status Scale criteria. The EQ-5D health status scale was used to evaluate the health status of patients after chemotherapy. The scale score was between 0 and 1, and the higher the scale score was, the better the health status of patients was reflected	From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.
Assessment of side effects associated with adjuvant therapy (Abbreviated Fatigue Scale)	The side effects of adjuvant therapy will be assessed according to the Concise Fatigue Scale (BFI) criteria, with a score between 0 and 10, with a lower score indicating less fatigue	From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.

Collaborators and Investigators

• Sponsor: Jiuda Zhao

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: October 13, 2024
• First Submitted That Met QC Criteria: October 13, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Vitamin D; Adverse Reaction
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D; Ergocalciferols
• Other Study ID Numbers: AHQU-2024004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No