- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05054517
Oral Glutamine and Thoracic/Upper Aerodigestive Tumors Radiation Toxicity
The Use of Oral Glutamine in Patients With Thoracic and Upper Aerodigestive Malignancies Who Undergo Radiotherapy: Results of a Prospective Observational Study
PROTOCOL FOR PREVENTIVE ADMINISTRATION OF GLUTAMINE TO AVOID RADIATE SIDE EFFECTS IN PATIENTS UNDER RADIOTHERAPY IN THE CHEST AND HEAD & NECK
PURPOSE OF THE STUDY
The purpose of the protocol is to study the acute and distant toxicity of the mucosa of the oral cavity and esophagus after radiotherapy for head-neck and tumors of the chest. Radiation therapy in all cases is a three-dimensional conformal technique with a linear accelerator.
INCLUSION CRITERIA
Patients undergoing radiotherapy with or without concomitant chemotherapy for Ca nasopharynx, hypopharynx, palate, tonsils, mouth base, parotid, tongue, cervix and esophagus as well as mediastinal and lung cancer.
EXCLUSION CRITERIA
Patients with psychiatric problems and inability to cooperate, as well as patients with gluten intolerance, as well as patients with hepatic encephalopathy or hyperammonemia, are excluded from the study.
METHODS
Oral glutamine administration starting 4 days before the start of radiotherapy and for a total of 3 months. The preparation is dissolved in water and taken orally 4 hours before radiotherapy and 4 hours before dinner.
FOLLOW UP
Immediately after completion of radiotherapy at 3, 6 and 12 months, orthoscopy (on symptoms) and oral mucosal examination will be performed on patients who have undergone cervical and mediastinal radiotherapy and their evaluation based on the EORTC-RTOG scale.
REFERENCES
- Anderson PM, Schroeder G, Skubitz KM. "Oral glutamine reduces the duration and severity of stomatitis after cytotoxic cancer chemotherapy". Cancer: 1998; 83: 1433-1439.
- Cerchietti LC, Navigante AH, Lutteral MA, Castro MA, Kirchuk R, Bonomi M et al. "Double-blinded, placebo-controlled trial on intravenous L-alanyl-L-glutamine in the incidence of oral mucosis following chemotherapy in patients with head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2006 Aug 1; 65 (5): 1330-7.
- Peterson DE, Jones JB, Petit RG 2nd. "Randomized, placebo-controlled trial of Saforis for prevention and treatment of oral mucositis in breast cancer patients receiving anthracycline-based chemotherapy. Cancer. 2007 Jan 15; 109(2): 322-31.
- Kozelsky TF, Meyers GE, Sloan JA, Shanahan TG, Dick SJ et al; North Central Cancer Treatment Group. Mayo Clinic "Phase III double-blind study of glutamine versus placebo for the prevention of acute diarrhea in patients receiving pelvic radiation therapy". J Clin Oncol 2003 May 1; 21 (9):1669-74.
- Topkan E, Yavuz MN, et al "Prevention of acute radiation-induced esophagitis with glutamine in non-small cell lung cancer patients treated with radiotherapy: Evaluation of clinical and dosimetric parameters". Lung Cancer, 2008 August 6.
- Ismael Membrive Conejo, Ana Reig Castillejo, Nuria Rodriguez de Dios, Palmira Foro Arnalot, Javier Sanz Latiesas, et al: "Prevention of acute radiation enteritis: efficacy and tolerance of glutamine". Clinical and Translational Oncology. Vol 13, Number 10 (2011), 760-763, DOI: 10.1007/st 2094-011-0729-3.
- Yoshida S, Kaibara A, Ishibashi N, Shirouzu K. "Glutamine supplementation in cancer patients" Nutrition. 2001: 17:766-768.
- Klimberg SV, McClellan Jl. "Glutamine, cancer and its therapy. Am J Surg. 1996;172: 172:418-424.
- Rouse K, Nwokedi E, Woodliff JE, Epstein J, Klimberg VS. "Glutamine enhances selectivity of chemotherapy through changes in glutathione metabolism. Ann Surg. 1995; 221:420-426.
- Baxevanis CN, Reclos GJ, Grittapis AD et al "Elevated PGE2 production by monocytes is responsible for the depressed levels of NK&LAK cell function in patients with breast cancer" Cancer. 1993; 12:491-501.
- Erdem NZ, Yasti AC, Atli M, et al. "The effects of perioperative oral enteral support with glutamine added elemental formulas in patients with gastrointestinal cancers: a prospective randomized clinical study. Nutr Res.2002:22:977-988.
- Berk L, James J, Schwartz A, Hug E, Mahadevan A, Samuels M et al. "A randomized, double-blind, placebo-controlled trial of a beta hydroxyl beta-methyl butyrate, glutamine, and arginine mixture for the treatment of cancer cachexia". Support Care Cancer. 2008 Oct; 16 (10): 1179-88. Epub 2008 Feb 22.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing radiotherapy with or without concomitant chemotherapy for Ca nasopharynx, hypopharynx, palate, tonsils, mouth base, parotid, tongue, cervix and esophagus as well as mediastinal and lung cancer.
Exclusion Criteria:
- Patients with psychiatric problems and inability to cooperate, as well as patients with gluten intolerance, as well as patients with hepatic encephalopathy or hyperammonemia are excluded from the study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoints were the incidence of grade 2 or greater in the observed toxicities, weight loss and the need for analgesic therapy
Time Frame: one month
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary endpoint was the length of the irradiated esophagus from radiotherapy (RT) treatment planning correlated with the use of opioids as analgesics.
Time Frame: one month
|
one month
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Athens Medical 2281/26-04-2013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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