Status:
NOT_YET_RECRUITING
Vitamin D Supplementation in Breast Cancer Patients
Lead Sponsor:
Abdelrahman Mahmoud
Conditions:
Peripheral Neuropathic Pain
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief 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 pa...
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-Cyclophosph...
Eligibility Criteria
Inclusion
- Female aged 18 to 65 years old.
- Histologically confirmed breast cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 \[21\] \[22\].
- 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.
- 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 \[23\].
- Vitamin D insufficiency defined as serum level \< 30 ng/ml.
- Ability to give informed consent as per the legal requirement.
Exclusion
- Prior neurotoxic chemotherapy including paclitaxel.
- Metastatic carcinoma.
- 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.
- 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.
- Patients who are scheduled to receive any neurotoxic chemotherapeutic agents such as platinum compounds (carboplatin, cisplatin), vinorelbine, eribulin, and ixabepilone.
- Diabetes mellitus
- 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.
- Known Fibromyalgia
- Gastric bypass surgery.
- Patients with chronic granuloma forming disorders (sarcoidosis or tuberculosis TB).
- Known hyperparathyroidism.
- Known thyroid dysfunction.
- Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
- Pregnancy and lactation.
- Hypercalcemia (corrected blood calcium \> 10.5 mg/dl or \> 2.6 mmol/L)\[24\]
- Hyperphosphatemia, serum phosphate concentration \> 4.5 mg/dL \[25\]
- History of symptomatic genitourinary stones within the past year.
- Allergy to any cholecalciferol dosage form component.
- Alcohol consumption.
- Regular use of vitamin D \> 2000 IU daily over the past year.
- Inability to swallow pills.
- 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.
- 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.
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06596122
Start Date
October 15 2024
End Date
December 30 2026
Last Update
September 19 2024
Active Locations (1)
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1
Ain Shams University (El-Demerdash) Hospital
Cairo, Egypt