Not Yet Recruiting

Phase 2

Age: 18Years - 65Years

FEMALE

ID06596122

The Effect of Vitamin D Supplementation in Breast Cancer Patients Receiving Taxane-based Chemotherapy

Led by Abdelrahman Mahmoud · Updated on 2024-09-19

132

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

Vitamin D Supplementation in Breast Cancer Patients

Who Can Participate

Age: 18Years - 65Years

FEMALE

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Research Team

Abdelrahman Mahmoud Dosoky, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

Similar Trials

Study of Safety and Effectiveness of Peripheral Nerve Stimul...

Postherpetic Neuralgia

Actively Recruiting

1 location

Laser Photobiomodulation Therapy to Treat Neuropathic Pain C...

Cancer Survivors

Actively Recruiting

2 locations

Phase 2 Study of Cannabis Components THC, CBD, and Their Com...

Neuropathic Pain

Actively Recruiting

6 locations

Study of Safety and Effectiveness of Peripheral Nerve Stimulation for Adults with Peripheral Neuropathic Pain

Laser Photobiomodulation Therapy to Treat Neuropathic Pain Caused by Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients A Randomized, Placebo-Controlled Phase II Clinical Trial

Phase 2 Study of Cannabis Components THC, CBD, and Their Combination for Treating Neuropathic Pain in Veterans

Comparing Three Motor Cortex rTMS Protocols for Treating Chronic Peripheral Neuropathic Pain in Adults

Study of High-Concentration Capsaicin Patch Treatment for Adults with Peripheral Neuropathic Pain in the Auvergne Rhne Alpes Region

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

The Effect of Vitamin D Supplementation in Breast Cancer Patients Receiving Taxane-based Chemotherapy

On this page

Sponsors

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

How is the study designed?

Similar Trials

Study of Safety and Effectiveness of Peripheral Nerve Stimul...

Laser Photobiomodulation Therapy to Treat Neuropathic Pain C...

Phase 2 Study of Cannabis Components THC, CBD, and Their Com...

Not the Right Trial for You?

On this page

Sponsors

Sponsors

Who Can Participate

Eligibility Criteria

How is the study designed?

Similar Trials

Study of Safety and Effectiveness of Peripheral Nerve Stimul...

Laser Photobiomodulation Therapy to Treat Neuropathic Pain C...

Phase 2 Study of Cannabis Components THC, CBD, and Their Com...

Sponsors