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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 2, 2023
    Last Updated
    May 2, 2023
    Sponsor
    Assiut University
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    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

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    Vit D and Peripheral Neuropathy in Taxane Naive Patients

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