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.
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-Cyclophosphamide followed by paclitaxel (AC-T) chemotherapy protocol. The intervention group will undergo paclitaxel-based chemotherapy, along with vitamin D replacement therapy. Conversely, the control group will follow the AC-T protocol without the addition of vitamin D replacement therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
132
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.
Ain Shams University (El-Demerdash) Hospital
Cairo, Egypt
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.
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.
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.
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.
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