Efficacy of Glutamine in Management of Radiation Mucositis
1 other identifier
interventional
40
1 country
2
Brief Summary
The goal of this \[ type of study: Clinical trial\] is to test effectiveness of glutamine in management of Radiation Induced Mucositis in head and neck cancer patients. The main question \[s\] \] is to \[ learn about, test, compare etc.\] it aims to answer are:
- 1.Is glutamine effective in management of Radiation Induced Mucositis?
- 2.Does Glutamine oral suspension affect the level of TGFβ1 in saliva of patients with radiation induced mucositis? participants will be asked to dissolve oral glutamine and maltodextrin in distalled water and swish and swallow three times daily during radiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 25, 2023
CompletedFirst Posted
Study publicly available on registry
May 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedMay 12, 2023
May 1, 2023
1.4 years
March 25, 2023
May 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from World Health Organization Oral Toxicity Scale Grading of Oral Mucositis during radiotherapy.
World Health Organization Oral Toxicity Scale Grading of Oral Mucositis ranges from "1,2,3,4) the grade1 means the least clinical sign and symptoms while grade 4 means the worst clinical sign and symptoms of mucositis.
Two points: -"baseline which is at the second week of radiotherapy" while -"the end of the radiotherapy is at seventh week of the radiotherapy or 4-5 weeks from baseline.
Change in the level of salivary transforming growth factor beta 1 during radiotherapy.
salivary level of transforming growth factor beta 1 assessment using enzyme linked immune assay may range from 10-4000ng/L
Two points: -"baseline which is at the second week of radiotherapy" while -"the end of the radiotherapy is at seventh week of the radiotherapy or 4-5 weeks from baseline.
Secondary Outcomes (1)
Change in Pain visual analog scale during radiotherapy.
Two points: -"baseline which is at the second week of radiotherapy" while -"the end of the radiotherapy is at seventh week of the radiotherapy or 4-5 weeks from baseline.
Study Arms (2)
Group I (Test group):
EXPERIMENTALWill include twenty patients receiving Glutamine oral suspension (5 grams of glutamine and 5 g maltodextrin dissolved in cold water) 30 min before a meal, 3 times per day through swish and swallow technique25 throughout the radiotherapy period.
Group II (Control group)
PLACEBO COMPARATORIncluded twenty patients receiving maltodextrin oral suspension (5 g maltodextrin dissolved in cold water) 30 min before a meal, 3 times per day through swish and swallow technique throughout the radiotherapy period along with general measures as well as analgesic drugs according to the WHO scale.
Interventions
Eligibility Criteria
You may qualify if:
- a) Patients with a confirmed histologic diagnosis of H\&N malignancy who are referred to non-palliative radiotherapy in the oral cavity.
- b) Patient who is receiving radiation therapy with intensity modified radiotherapy IMRT or 3D techniques.
- c) Patients received 50-70 Gy of total radiation at the rate of 2 Gy/fraction daily and 5 fractions/week.
- d) Patient who received concurrent chemotherapy with radiotherapy e) Presence of Oral Mucositis f) Age 20-70 years old g) Willing to participate in the study h) Able to complete the study assessments
You may not qualify if:
- a) Have a confirmed or medically treated diabetes mellitus25 b) Radiotherapy within the last 6 months prior to this study c) Vulnerable patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
ain shams University
Cairo, 11565, Egypt
Fatma E.Sayed
Cairo, Egypt
Related Publications (3)
Arutla M, Raghunath M, Deepika G, Jakkampudi A, Murthy HVV, Rao GV, Reddy DN, Talukdar R. Efficacy of enteral glutamine supplementation in patients with severe and predicted severe acute pancreatitis- A randomized controlled trial. Indian J Gastroenterol. 2019 Aug;38(4):338-347. doi: 10.1007/s12664-019-00962-7. Epub 2019 Oct 14.
PMID: 31612309RESULTFahr MJ, Kornbluth J, Blossom S, Schaeffer R, Klimberg VS. Harry M. Vars Research Award. Glutamine enhances immunoregulation of tumor growth. JPEN J Parenter Enteral Nutr. 1994 Nov-Dec;18(6):471-6. doi: 10.1177/0148607194018006471.
PMID: 7602720RESULTIbrahim SS, Hassanein FEA, Zaky HW, Gamal H. Clinical and biochemical assessment of the effect of glutamine in management of radiation induced oral mucositis in patients with head and neck cancer: Randomized controlled clinical trial. J Stomatol Oral Maxillofac Surg. 2024 Jun;125(3S):101827. doi: 10.1016/j.jormas.2024.101827. Epub 2024 Mar 15.
PMID: 38493953DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Suzan SA Ibrahim, professor
faculty of Dentistry- Ainshams university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2023
First Posted
May 12, 2023
Study Start
January 1, 2022
Primary Completion
June 1, 2023
Study Completion
August 1, 2023
Last Updated
May 12, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share