Vitamin D Supplementation in Breast Cancer Patients

Trial Title: Vitamin D Supplementation in Breast Cancer Patients

NCT ID: NCT06596122

Condition: Peripheral Neuropathic Pain

Conditions: Official terms:
Neuralgia
Vitamin D
Cholecalciferol

Conditions: Keywords:
Cholecalciferol
Breast cancer
Neuropathic pain
Taxane
Paclitaxel
Vitamin D3

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Outcomes Assessor)

Masking description: Only the neurologist conducting the Modified Total Neuropathy Score (mTNS) assessment will be blinded.

Intervention:

Intervention type: Drug
Intervention name: Vitamin D (Cholecalciferol )
Description: In conjunction with the AC-T chemotherapy protocol, individuals in the intervention group who have a vitamin D deficiency will receive an oral loading dose of 50,000 IU weekly for eight weeks. Subsequently, they will be given 100,000 IU monthly until the completion of their chemotherapy treatment.
Arm group label: Intervention group

Summary: It is a randomized clinical trial aimed at exploring the neuroprotective effect of vitamin D3 (Cholecalciferol) supplementation in conjunction with paclitaxel-based chemotherapy among breast cancer patients with vitamin D insufficiency or deficiency.

Detailed description: This study is a two-arm randomized controlled trial with 132 participants, evenly randomized into an intervention group and a control group. Both groups are scheduled to receive Adriamycin-Cyclophosphamide followed by paclitaxel (AC-T) chemotherapy protocol. The intervention group will undergo paclitaxel-based chemotherapy, along with vitamin D replacement therapy. Conversely, the control group will follow the AC-T protocol without the addition of vitamin D replacement therapy.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Female aged 18 to 65 years old. 2. Histologically confirmed breast cancer. 3. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 [21] [22]. 4. All patients should fulfill the criteria of the initiation of taxane-based chemotherapy such as absolute neutrophil count (ANC) > 1,500/mcL, platelets > 100,000/mcL, hemoglobin ≥ 9 g/mL, Aspartate Aminotransferase (AST) (Serum Glutamic-Oxaloacetic Transaminase) (SGOT) to Alanine Aminotransferase (ALT), (Serum Glutamic-Pyruvic Transaminase) (SGPY) ratio (AST (SGOT)/ALT (SGPT)) < 2.5 x institutional upper limit of normal (ULN), total bilirubin less than or equal to 1.5 x institutional ULN, serum creatinine < 1.5 x institutional ULN. 5. Stage I-III breast cancer scheduled to undergo adjuvant or neoadjuvant paclitaxel-based chemotherapy for breast cancer using doxorubicin 60 mg/m² and cyclophosphamide 600 mg/m² followed by paclitaxel 80 mg/m² weekly for 12 weeks protocol code BRAJACTW [23]. 6. Vitamin D insufficiency defined as serum level < 30 ng/ml. 7. Ability to give informed consent as per the legal requirement. Exclusion Criteria: 1. Prior neurotoxic chemotherapy including paclitaxel. 2. Metastatic carcinoma. 3. History of any other malignancy except malignancy that was treated with curative intent and for which there has been no known active disease for more than 3 years prior to randomization, curatively treated non-melanoma skin malignancy, cervical cancer in situ, in situ ductal carcinoma, or breast in situ lobular carcinoma. 4. Grade II neuropathy or higher based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. neurosensory or neuromotor neuropathy, regardless of causality. 5. Patients who are scheduled to receive any neurotoxic chemotherapeutic agents such as platinum compounds (carboplatin, cisplatin), vinorelbine, eribulin, and ixabepilone. 6. Diabetes mellitus 7. Psychiatric disorders that limit ability to comply with study protocol i.e., history of regular exacerbation of major psychosis (schizophrenia, bipolar disorder) in last 2 years. 8. Known Fibromyalgia 9. Gastric bypass surgery. 10. Patients with chronic granuloma forming disorders (sarcoidosis or tuberculosis TB). 11. Known hyperparathyroidism. 12. Known thyroid dysfunction. 13. Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection. 14. Pregnancy and lactation. 15. Hypercalcemia (corrected blood calcium > 10.5 mg/dl or > 2.6 mmol/L)[24] 16. Hyperphosphatemia, serum phosphate concentration > 4.5 mg/dL [25] 17. History of symptomatic genitourinary stones within the past year. 18. Allergy to any cholecalciferol dosage form component. 19. Alcohol consumption. 20. Regular use of vitamin D > 2000 IU daily over the past year. 21. Inability to swallow pills. 22. Medications that may interfere with vitamin D metabolism, including enzyme inducing anticonvulsants, lithium, phenytoin, verapamil, orlistat, tuberculosis medications as isoniazid, and/or rifampin and estrogen-containing medications. 23. Patients receiving any of the following medications used to prevent CIPN: vitamin E, glutamine, nortriptyline, amitriptyline, tricyclic antidepressants, pregabalin, and duloxetine and other nutritional supplements as vitamin B during taxane administration.

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Ain Shams University (El-Demerdash) Hospital

Address:
City: Cairo
Country: Egypt

Contact:
Last name: Abdelrahman Mahmoud Dosoky, Dr

Phone: +201148534951
Email: abdalrahman.mahmoud@pharma.cu.edu.eg

Start date: October 15, 2024

Completion date: December 30, 2026

Lead sponsor:
Agency: Abdelrahman Mahmoud
Agency class: Other

Source: Cairo University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06596122