Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852496
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-10
First Post:
2023-05-02
Brief Title:
Vit D and Peripheral Neuropathy in Taxane Naive Patients
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Vit D and Peripheral Neuropathy in Taxane Naive Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the efficacy of vit D supplement in cancer patients which receive taxane drugs with vit D deficiency and complaining from Peripheral neuropathy
Detailed Description:
Taxanes are a class of chemotherapy agents that promote the polymerization of tubulin into highly stable intracellular microtubules These microtubules cause cell death by interfering with normal cell division 12 The first taxane developed and tested in the field of oncology was paclitaxel34 The introduction of paclitaxel to the armamentarium of oncologic therapy in the early 1990s had a great impact on the standard of care in lung carcinoma breast carcinoma ovarian carcinoma and other solid tumors Subsequent to this development another taxane docetaxel was introduced 56 Unfortunately taxane therapy is associated with side effects such as peripheral neuropathy myelosuppression arthralgias myalgias and skin reactions that may adversely affect patient-reported quality of life QOL Peripheral neuropathy in particular can be severe This toxicity is cumulative across the course of therapy can be a dose-limiting toxicity and may lead to dose reduction or cessation of therapy 7 Peripheral neuropathies encompass disorders of peripheral nerve cells and fibers which manifest secondary to a wide range of pathologies These nerves include cranial nerves spinal nerve roots ganglia nerve trunks division along with nerves of the autonomic nervous system The most frequently encountered symptoms of peripheral neuropathy include numbness and paresthesias pain weakness and loss of deep tendon reflexes may accompany these symptoms 8 Vitamin D is a fat-soluble vitamin that plays an important role in calcium homeostasis and bone metabolism vitamin-D deficiency is associated with osteoporosis increased risk of falls and fragility fractures Many conflicting recent studies are now showing an association between vitamin D deficiency and cancer cardiovascular disease diabetes autoimmune diseases and depression 9 Initial supplementation for 8 weeks with Vitamin D3 either 6000 IU daily or 50000 IU weekly can be considered Once the serum 25-hydroxyvitamin D level exceeds 30 ngmL a daily maintenance dose of 1000 to 2000 IU is recommended A higher-dose initial supplementation with vitamin D3 at 10000 IU daily may be needed in high-risk adults who are vitamin D deficient African Americans Hispanics obese taking certain medications malabsorption syndrome Once serum 25-hydroxyvitamin D level exceeds 30ngmL 3000 to 6000 IUday maintenance dose is recommended10 A 2022 ASCO meeting abstract by Chen et al reported that patients with vitamin D deficiency had more paclitaxel-induced neuropathy than those with normal vitamin D blood concentrations 11
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None