Vit D and Peripheral Neuropathy in Taxane Naive Patients

NCT05852496 | Unknown Phase 2

• 1 other identifier: 357167
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Vitamin D Deficiency; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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

  after 6 months

Secondary Outcomes (1)

• The Toronto Clinical Neuropathy Score (TCNS)

  after 6 months

Study Arms (2)

Vitamin D supplement

ACTIVE COMPARATOR

Vitamin D supplement intake for 6 months

Drug: Vitamin D

Placebo group

PLACEBO COMPARATOR

Group with no vitamin D supplement treatment

Drug: Vitamin D

Interventions

Vitamin D DRUG

vitamin D supplement in cancer patients which receive taxane drugs with vit D deficiency and complaining from Peripheral neuropathy.

Placebo group; Vitamin D supplement

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any cancer patient \> 18 years old receive taxane treatment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Vitamin D Deficiency; Peripheral Nervous System Diseases

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05