Effect of Vitamin D Diffiency on Oral Mucosa in Patients Recieving Methotrexate Chemotherapy

NCT04096846 | Unknown

• 1 other identifier: Vit D and oral mucositis
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

it's a prospective study aiming to improve quality of life of patients with acute lymphoblastic leukemia suffering from oral mucositis, receiving courses of methotrexate chemotherapy , by measuring vitamin D in those patients before induction therapy and the change in its level during treatment, that associated with methotrexate-induced oral mucositis, taking in consideration serum level of methotrexate, so we may have assiotiation between vitamin D difficiency and oral mucositis . at the end we can have preventive interventions to protect against this harmful side effect.

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Relation between vitamin D difficiency and oral mucositis in patients with leukemia

  Difficiency of vitamin D in patients with acute lymphoblastic leukemia recieving methotrexte assiociated with oral mucositis and so later on we can improve thier quality of life by supplying vitamin D.

  baseline 6 months to 1 year

Interventions

laboratory investigation DIAGNOSTIC_TEST

detection of serum level of methotrexate and serum level of vitamin D

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pediatric and old patients with acute lymphocytic leukemia treated with methotrexate based chemotherapy

You may qualify if:

• patients with acute lymphocytic leukemia in South Egypt Cancer Institute
• patients recieving methotrexate in protocol of treatment
• both sex included

You may not qualify if:

• patients with other types of tumors
• patients refuse to join the research
• patients with comorbid hepatic or renal impairment

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Al-Maweri SA, Halboub E, Al-Sufyani G, Alqutaibi AY, Shamala A, Alsalhani A. Is vitamin D deficiency a risk factor for recurrent aphthous stomatitis? A systematic review and meta-analysis. Oral Dis. 2020 Sep;26(6):1116-1123. doi: 10.1111/odi.13189. Epub 2019 Oct 8.

  PMID: 31493304 BACKGROUND

• Anand A, Singh S, Sonkar AA, Husain N, Singh KR, Singh S, Kushwaha JK. Expression of vitamin D receptor and vitamin D status in patients with oral neoplasms and effect of vitamin D supplementation on quality of life in advanced cancer treatment. Contemp Oncol (Pozn). 2017;21(2):145-151. doi: 10.5114/wo.2017.68623. Epub 2017 Jun 30.

  PMID: 28947884 BACKGROUND

• Oosterom N, Dirks NF, Heil SG, de Jonge R, Tissing WJE, Pieters R, van den Heuvel-Eibrink MM, Heijboer AC, Pluijm SMF. A decrease in vitamin D levels is associated with methotrexate-induced oral mucositis in children with acute lymphoblastic leukemia. Support Care Cancer. 2019 Jan;27(1):183-190. doi: 10.1007/s00520-018-4312-0. Epub 2018 Jun 19.

  PMID: 29922939 BACKGROUND

• Lalla RV, Choquette LE, Feinn RS, Zawistowski H, Latortue MC, Kelly ET, Baccaglini L. Multivitamin therapy for recurrent aphthous stomatitis: a randomized, double-masked, placebo-controlled trial. J Am Dent Assoc. 2012 Apr;143(4):370-6. doi: 10.14219/jada.archive.2012.0179.

  PMID: 22467697 BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Moustafa Mahmoud Hamdy, Phd

  Assiut University

  STUDY DIRECTOR

• Nevin Abdelazim Abelalim, Phd

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Magy Ibrahim Anis Rizkallah, Bachelor

CONTACT

01282495775; magyibraheem@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator of cancer biology

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 20, 2019

Record last verified: 2019-09