Clinical trial · Interventional
Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer
NCT06642441CI-TRIAL-00084851recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Reaction | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy | — | UNRESOLVED | — |
| Vitamin D | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Chemotherapy + vitamin D2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy + vitamin D2
- description
- 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.
- interventionNames
- Drug: Chemotherapy + vitamin D2
- type
- OTHER
- label
- chemotherapy
- description
- 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.
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.