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Randomized, double-blind, placebo-controlled, crossover trial of enteral glutamine supplementation on inflammatory markers and clinical of mucositis in childhood cancer patients

Randomized, double-blind, placebo-controlled, crossover trial of enteral glutamine supplementation on inflammatory markers and clinical of mucositis in childhood cancer patients

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251022009
Enrollment
48
Registered
2025-10-22
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric oncology patients under Chemotherapy session Chemotherapy, Glutamine, Biomarker, Oral mucositis, Children

Interventions

Dosage Body weight under 30 kg : 0.65 gm/kg/day Body weight above 30 kg : 15 gram per oral 2 times/day (adult dose) Continue for 14 days during Chemotherapy session,Dosage Body weight under 30 kg :
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
L-Glutamine powder (BioKyowa Inc., CAS No. 56-85-9),Dextrin (King Chulalongkorn memorial hospital)

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age 1-18 year old 2. Pediatric oncology patients under Chemotherapy session at King Chulalongkorn Memorial hospital, Thai Red Cross society 3. Receiving the same chemotherapy regimen, dosage and duration on two separate occasions, with at least a one-week interval between courses. 4. Receiving chemotherapy that includes at least one of this following: Methotrexate, Doxorubicin, Cyclophosphamide, Cisplatin or Cytarabine

Exclusion criteria

Exclusion criteria: 1. Patients with cancer who have received chemotherapy for the first time (induction phase of treatment) 2. Patients with cancer that has spread to the oral tissues or with abnormal cancer types in the oral cavity. 3. Experiencing inflammation or infection in the oral tissues before participating in the research study for 1 week 4. Unable to consume any other products besides cancer treatment drugs due to the severity of the cancer or complications 5. Receiving treatment in the intensive care unit or being treated with inotrope 6. Consuming food or nutritional supplements that have been studied and found to affect the treatment of oral inflammation, which may include: Medical nutritional supplements (Oral Nutritional Supplement) or Total Parenteral Nutrition containing Glutamine, honey, Vitamins A, B, C, D, and E, Hyaluronic acid, Triamcinolone, Licorice root (Glycyrrhiza glabra), Zinc, or history of allergy to Glutamine components

Design outcomes

Primary

MeasureTime frame
IL-6 2 weeks Electrochemiluminescence Immunoassay (ECLIA),C-reactive protein 2 weeks Turbidimetric Immunoassay,Antioxidant GSH 2 weeks High Performance Liquid Chromatography (HPLC),TNF alpha 2 weeks Enzyme-Linked Immunosorbent Assay (ELISA)

Secondary

MeasureTime frame
Mucositis 2 weeks World Health Organization Oral Mucositis Grading Scale

Countries

Thailand

Contacts

Public ContactBuabongkoj Punnanan

King Chulalongkorn Memorial Hospital

pun.bbk93@gmail.com0636696246

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026