Vitamin D Supplementation in Breast Cancer Patients
ConditionPeripheral Neuropathic Pain
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorAbdelrahman Mahmoud
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Vitamin D (Cholecalciferol )
Treatment groups
132 Participants
are divided into 2 treatment groupsSponsors and collaborators
Abdelrahman Mahmoud
Lead sponsor
Cairo University
Sponsor institution
Source ClinicalTrials.gov