Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Intervention groupActive comparator 1 intervention
Group B: The control groupNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

The modified total neuropathy score mTNS.

The Modified Total Neuropathy Score (mTNS) is a tool including six items that evaluate peripheral neuropathy symptoms by their presence, location, and characteristics, including sensory and motor symptoms, response to pinprick, vibration sensitivity, muscle strength, and deep tendon reflexes. Each item is scored on a scale from 0 to 4, with the total possible score ranging from 0 to 24. The sum of these scores yields a total score, with higher scores indicating more severe neuropathy.

Time frame
The change in mTNS will be compared at weeks 18 and 24 relative to baseline.
2

EORTC QLQ-CIPN20

The assessment of taxane-induced peripheral neuropathy will be carried out through interviews utilizing the Arabic version of the EORTC QLQ-CIPN20. This 20-item questionnaire, which includes sensory, motor, and autonomic subscales, will be employed for evaluations.

Time frame
Taxane-induced peripheral neuropathy using (EORTC QLQ-CIPN20) at weeks 13, 15,18, 21 and 24.
3

Quality of life

Quality of life (QOL) assessments will be conducted through interviews utilizing the Arabic version of the Functional Assessment of Cancer Therapy Breast Symptom Index (FBSI).

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abdelrahman Mahmoud

Lead sponsor

Cairo University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: