Vitamin D and Calcium Supplementation in Breast Cancer

NCT05523609 | Unknown Phase 2

• 1 other identifier: Vitamin D and breast cancer
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at assessing the vitamin Dstatus in breast cancer patients who receive letrozole for more than two months and to evaluate effects of vitamin D3 and calcium supplementation on arthalgia caused by letrozole on these patients.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Osteocalcin level

  Osteocalcin level at base line and 12 weeks

  12 weeks

Study Arms (2)

Control Group

EXPERIMENTAL

20 patients will receive Letrozole only for 12 weeks.

Drug: Letrozole 2.5mg

VitD/Ca group

EXPERIMENTAL

20 patients will receive Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks.

Drug: Letrozole + vitamin D3 and calcium

Interventions

Letrozole 2.5mg DRUG

20 patients will receive Letrozole only for 12 weeks

Control Group

Letrozole + vitamin D3 and calcium DRUG

20 patients will receive Letrozole in addition to 2000 IU vitamin D3 per day for 12 weeks.

VitD/Ca group

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed breast cancer patients.
• Postmenopausal hormone receptor positive.
• Patients receiving letrozole for more than two months
• Gender: Female.
• Age: ≥ 50 years old.

You may not qualify if:

• Patients with bone metastasis.
• History of renal stones.
• Serum calcium \>11mg/L.
• Patients with renal insufficiency.
• Patients taking steroid hormone replacement therapy.
• Second Malignancy.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta Cancer Center

Tanta, El-Gharbia, GHR, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole; Cholecalciferol; Calcium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Sahar K Hegazy, Professor

  Head of clinical Pharmacy Department

  STUDY DIRECTOR

Central Study Contacts

Mai A Elgebaly, Pharm D

CONTACT

01061412257; dr.mai.elgebaly@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Model Details: Forty breast cancer patients were included. They were divided into 2 equal groups: Control group received Letrozole only, and VitD/Ca group received Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks. Baseline serum 25-hydroxy vitamin D concentrations were assayed and standard health assessment questionnaire was completed to assess the disability caused by musculoskeletal symptoms.

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 31, 2022
• Study Start: November 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

EG (1)