Vitamin D Supplementation in Breast Cancer Patients

NCT06596122 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Vitamin D in cancer patients
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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 patients with vitamin D insufficiency or deficiency.

Conditions

Peripheral Neuropathic Pain

Keywords

Cholecalciferol; Breast cancer; Neuropathic pain; Taxane; Paclitaxel; Vitamin D3

Outcome Measures

Primary Outcomes (1)

• The cumulative incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN)

  The incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN) will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

  PIPN will be assessed throughout the 12-weeks paclitaxel administration phase.

Secondary Outcomes (3)

• The modified total neuropathy score mTNS.

  The change in mTNS will be compared at weeks 18 and 24 relative to baseline.

• EORTC QLQ-CIPN20

  Taxane-induced peripheral neuropathy using (EORTC QLQ-CIPN20) at weeks 13, 15,18, 21 and 24.

• Quality of life

  Quality of life (QOL) assessed at the first week, then at weeks 13 and 24.

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

In conjunction with the AC-T chemotherapy protocol, individuals in the intervention group who have a vitamin D deficiency will receive vitamin D replacement therapy.

Drug: Vitamin D (Cholecalciferol )

The control group

NO INTERVENTION

only the standard of care will be administered.

Interventions

Vitamin D (Cholecalciferol ) DRUG

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)\[24\]

Sponsors & Collaborators

• Abdelrahman Mahmoud: lead

Study Sites (1)

Ain Shams University (El-Demerdash) Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms; Neuralgia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Abdelrahman Mahmoud Dosoky, Dr

CONTACT

1148534951; abdalrahman.mahmoud@pharma.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the neurologist conducting the Modified Total Neuropathy Score (mTNS) assessment will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

EG (1)