Clinical Trials Logo

Clinical Trial Summary

This study evaluated the benefits of immunonutrition regarding the prevention of severe mucositis. Patients with head and neck cancer (HNC) undergoing definitive concurrent chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase II study. Patients were randomly assigned to receive an immunonutrition containing omega-3-fatty acids, arginine, dietary nucleotides, and soluble fiber or an isocaloric isonitrogenous control. All patients received the assigned product 5 days before each chemotherapy session. The proportion of patients with severe mucositis was compared between the immunonutrition and control groups.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05101889
Study type Interventional
Source Prince of Songkla University
Contact
Status Completed
Phase Phase 2
Start date January 11, 2013
Completion date January 31, 2017

See also
  Status Clinical Trial Phase
Completed NCT02229136 - Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus Phase 2
Terminated NCT03843554 - Commensal Oral Microbiota in Head and Neck Cancer N/A
Enrolling by invitation NCT02662374 - Oral Hygiene Regimen in Patients on HCT Phase 4
Completed NCT00938080 - Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck Phase 1
Completed NCT00756951 - Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer Phase 2
Completed NCT00701688 - Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Phase 1
Not yet recruiting NCT05059613 - Thalidomide With or Without Probiotics in Radioactive Oral Mucositis N/A
Completed NCT04440930 - White Tea for Prevention of Chemotherapy Induced Mucositis N/A
Completed NCT05705622 - The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients N/A
Completed NCT02399228 - A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Oral Mucositis Phase 2
Withdrawn NCT02589860 - Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
Active, not recruiting NCT01772706 - Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer N/A
Enrolling by invitation NCT06122636 - Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC N/A
Completed NCT03689712 - ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients Phase 3
Terminated NCT02539342 - Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy Phase 3
Completed NCT02555501 - Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy Phase 3
Completed NCT01789658 - Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation N/A
Completed NCT00790322 - Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy Phase 3
Recruiting NCT00549952 - Observational Study of Anti-Cancer Therapy Induced Oral Mucositis in Korean Cancer Patients N/A
Completed NCT00289003 - The Protective Effect of Soluble Beta-1,3/1,6-Glucan Compared to Placebo in Oral Mucositis in Head and Neck Cancer Patients Phase 2