Assessing vitamin D and calcium effects in breast cancer patients on letrozole
Effect of Vitamin D and Calcium Supplementation on Letrozole-induced Musculoskeletal Side Effects in Breast Cancer Egyptian Patients
This study tests if adding vitamin D and calcium to the treatment of postmenopausal breast cancer patients on letrozole can help reduce muscle and joint pain they might be experiencing.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT05523609 on ClinicalTrials.gov |
What this trial studies
This study evaluates the vitamin D status in postmenopausal breast cancer patients who have been on letrozole for over two months. It aims to determine the impact of vitamin D3 and calcium supplementation on musculoskeletal symptoms caused by letrozole. Forty participants are divided into two groups: one receiving letrozole alone and the other receiving letrozole along with vitamin D3 and calcium for 12 weeks. The study measures baseline vitamin D levels and assesses health-related quality of life through questionnaires.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 50 and older with newly diagnosed hormone receptor-positive breast cancer receiving letrozole.
Not a fit: Patients with bone metastasis, renal issues, or those on steroid hormone replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could alleviate musculoskeletal symptoms in breast cancer patients undergoing letrozole treatment.
How similar studies have performed: While the specific combination of vitamin D and calcium with letrozole is being explored here, previous studies have indicated potential benefits of vitamin D supplementation in managing musculoskeletal symptoms in cancer patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tanta, El-Gharbia
- Tanta Cancer Center — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mai A Elgebaly, Pharm D
- Email: dr.mai.elgebaly@gmail.com
- Phone: 01061412257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.