Back to resultsVitamin D and Calcium Supplementation in Breast Cancer
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Letrozole 2.5mg
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed breast cancer patients.
- Postmenopausal hormone receptor positive.
- Patients receiving letrozole for more than two months
- Gender: Female.
- Age: ≥ 50 years old.
Exclusion Criteria:
- Patients with bone metastasis.
- History of renal stones.
- Serum calcium >11mg/L.
- Patients with renal insufficiency.
- Patients taking steroid hormone replacement therapy.
- Second Malignancy.
Sites / Locations
- Tanta Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control Group
VitD/Ca group
Arm Description
20 patients will receive Letrozole only for 12 weeks.
20 patients will receive Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks.
Outcomes
Primary Outcome Measures
Osteocalcin
Osteocalcin level at base line and after 12 weeks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05523609
Brief Title
Vitamin D and Calcium Supplementation in Breast Cancer
Official Title
Effect of Vitamin D and Calcium Supplementation on Letrozole-induced Musculoskeletal Side Effects in Breast Cancer Egyptian Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Background: Vitamin D deficiency (< 10 ng/mL) and insufficiency (10-30 ng/mL) may contribute to musculoskeletal symptoms observed in patients taking letrozole. This study was undertaken to assess the vitamin D status in breast cancer patients who received letrozole for > 6 months and to evaluate the effects of vitamin D3 and calcium supplementation on them.
Methods: 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Experimental
Arm Description
20 patients will receive Letrozole only for 12 weeks.
Arm Title
VitD/Ca group
Arm Type
Experimental
Arm Description
20 patients will receive Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Letrozole 2.5mg
Other Intervention Name(s)
2000 IU Vitamin D, 1000 mg calcium
Intervention Description
20 patients will receive Letrozole in addition to 2000 IU vitamin D3 per day for 12 weeks.
Primary Outcome Measure Information:
Title
Osteocalcin
Description
Osteocalcin level at base line and after 12 weeks
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed breast cancer patients.
Postmenopausal hormone receptor positive.
Patients receiving letrozole for more than two months
Gender: Female.
Age: ≥ 50 years old.
Exclusion Criteria:
Patients with bone metastasis.
History of renal stones.
Serum calcium >11mg/L.
Patients with renal insufficiency.
Patients taking steroid hormone replacement therapy.
Second Malignancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mai A Elgebaly, Pharm D
Phone
01061412257
Ext
002
Email
dr.mai.elgebaly@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar K Hegazy, Professor
Organizational Affiliation
Head of clinical Pharmacy Department
Official's Role
Study Director
Facility Information:
Facility Name
Tanta Cancer Center
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
GHR
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai Aboelyazid Hamouda, Pharm D
Phone
01061412257
Ext
0
Email
pg_55464@pharm.tanta.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Vitamin D and Calcium Supplementation in Breast Cancer
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