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

NCT06642441 | Recruiting DMC

• 1 other identifier: AHQU-2024004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Vitamin D; Chemotherapy; Breast Cancer; Adverse Reaction

Keywords

Vitamin D; Breast Cancer; Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation of side effects associated with adjuvant therapy (CTCAE v5.0)

  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)

  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)

  From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.

Study Arms (2)

Chemotherapy + vitamin D2

EXPERIMENTAL

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

chemotherapy

OTHER

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

Interventions

Chemotherapy + vitamin D2 DRUG

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.

Chemotherapy + vitamin D2

Chemotherapy DRUG

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.

chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of invasive breast cancer.
• Prior systemic treatment for the treatment or prevention of breast cancer.
• Known allergic reactions to vitamin D or calcium compounds.
• Comorbidities that may affect vitamin D or calcium balance or bone health.
• Vitamin D or calcium supplementation in the past 3 months.
• Presence of other tumors.
• Pregnant or lactating women.
• Individuals who do not wish to participate in the study.

Sponsors & Collaborators

• Jiuda Zhao: lead

Study Sites (2)

Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China

NOT YET RECRUITING

Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy; Ergocalciferols

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Jiuda Zhao

CONTACT

869716230893; jiudazhao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Breast Disease Diagnosis and Treatment Center

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 15, 2024
• Study Start: December 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: January 17, 2025

Record last verified: 2024-10

Locations

CN (2)