Vitamin D supplementation to reduce chemotherapy side effects in breast cancer patients

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

This study is testing whether taking vitamin D can help breast cancer patients feel better and have fewer side effects while they are receiving chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Affiliated Hospital of Qinghai University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Xining, Qinghai and 1 other locations)
• Trial ID: NCT06642441 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial investigates the impact of vitamin D supplementation on the side effects experienced by breast cancer patients undergoing adjuvant chemotherapy. Participants will be divided into two groups, both receiving standard chemotherapy, with one group also receiving vitamin D2. Blood samples and imaging will be collected before treatment and after every two cycles to assess adverse events. The primary focus is on documenting severe adverse reactions during the chemotherapy process.

Who should consider this trial

Good fit: Ideal candidates are breast cancer patients aged 18 to 80 with low serum vitamin D levels who are about to start adjuvant chemotherapy.

Not a fit: Patients with a history of invasive breast cancer or those who have previously received chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help reduce the severity of chemotherapy side effects for breast cancer patients.

How similar studies have performed: While there have been studies on vitamin D's role in cancer treatment, this specific approach to mitigate chemotherapy side effects is relatively novel.

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.

Where this trial is running

Xining, Qinghai and 1 other locations

• Qinghai University Affiliated Hospital — Xining, Qinghai, China (Not_yet_recruiting)
• Qinghai University Affiliated Hospital — Xining, Qinghai, China (Recruiting)

Study contacts

• Study coordinator: Jiuda Zhao

Conditions Vitamin D; Chemotherapy; Breast Cancer; Adverse Reaction