Vit D and Peripheral Neuropathy in Taxane Naive Patients
Primary Purpose
Vitamin D Deficiency, Peripheral Neuropathy
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional prevention trial for Vitamin D Deficiency
Eligibility Criteria
Inclusion Criteria: Any cancer patient > 18 years old receive taxane treatment Exclusion Criteria: Patient which receive any line of treatment cause Peripheral neuropathy before taxane. Chronic disease associated with neuropathy such as diabetes mellitus, Guillain-Barre syndrome and autoimmune disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin D supplement
Placebo group
Arm Description
Vitamin D supplement intake for 6 months
Group with no vitamin D supplement treatment
Outcomes
Primary Outcome Measures
Grades of neuropathy according to the World Health Organization rating scale
Grade 0 corresponds to no symptoms of neuropathy, grade 1 corresponds to paresthesias (a tingling, tickling or prickling sensation) and/or decreased tendon reflexes, grade 2 corresponds to severe paresthesias and/or mild weakness, grade 3 corresponds to intolerable paresthesias and /or marked motor loss, Grade 4 Paralysis
Secondary Outcome Measures
The Toronto Clinical Neuropathy Score (TCNS)
Valid and reliable scale for use in common non-diabetic polyneuropathies. Primarily for the feet. Most of the testing is done on or near the toes. Light touch testing is done with a 10 gm monofilament on the dorsum of the large toe
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05852496
Brief Title
Vit D and Peripheral Neuropathy in Taxane Naive Patients
Official Title
Vit D and Peripheral Neuropathy in Taxane Naive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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. (1,2) The first taxane developed and tested in the field of oncology was paclitaxel.(3,4 )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. (5,6) 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 6,000 IU daily or 50,000 IU weekly can be considered. Once the serum 25-hydroxyvitamin D level exceeds 30 ng/mL, a daily maintenance dose of 1,000 to 2,000 IU is recommended. A higher-dose initial supplementation with vitamin D3 at 10,000 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 30ng/mL, 3000 to 6000 IU/day maintenance dose is recommended.(10) 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Peripheral Neuropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D supplement
Arm Type
Active Comparator
Arm Description
Vitamin D supplement intake for 6 months
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Group with no vitamin D supplement treatment
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
vitamin D supplement in cancer patients which receive taxane drugs with vit D deficiency and complaining from Peripheral neuropathy.
Primary Outcome Measure Information:
Title
Grades of neuropathy according to the World Health Organization rating scale
Description
Grade 0 corresponds to no symptoms of neuropathy, grade 1 corresponds to paresthesias (a tingling, tickling or prickling sensation) and/or decreased tendon reflexes, grade 2 corresponds to severe paresthesias and/or mild weakness, grade 3 corresponds to intolerable paresthesias and /or marked motor loss, Grade 4 Paralysis
Time Frame
after 6 months
Secondary Outcome Measure Information:
Title
The Toronto Clinical Neuropathy Score (TCNS)
Description
Valid and reliable scale for use in common non-diabetic polyneuropathies. Primarily for the feet. Most of the testing is done on or near the toes. Light touch testing is done with a 10 gm monofilament on the dorsum of the large toe
Time Frame
after 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any cancer patient > 18 years old receive taxane treatment
Exclusion Criteria:
Patient which receive any line of treatment cause Peripheral neuropathy before taxane.
Chronic disease associated with neuropathy such as diabetes mellitus, Guillain-Barre syndrome and autoimmune disease.
12. IPD Sharing Statement
Learn more about this trial
Vit D and Peripheral Neuropathy in Taxane Naive Patients
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