Ignite Creation Date:
2024-05-06 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05054517
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2021-09-14
Brief Title:
Oral Glutamine and ThoracicUpper Aerodigestive Tumors Radiation Toxicity
Sponsor:
National and Kapodistrian University of Athens
Organization:
National and Kapodistrian University of Athens
Study Overview
Official Title:
The Use of Oral Glutamine in Patients With Thoracic and Upper Aerodigestive Malignancies Who Undergo Radiotherapy Results of a Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
1 Anderson PM Schroeder G Skubitz KM Oral glutamine reduces the duration and severity of stomatitis after cytotoxic cancer chemotherapy Cancer 1998 83 1433-1439
2 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
3 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 1092 322-31
4 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 91669-74
5 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
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 101007st 2094-011-0729-3
7 Yoshida S Kaibara A Ishibashi N Shirouzu K Glutamine supplementation in cancer patients Nutrition 2001 17766-768
8 Klimberg SV McClellan Jl Glutamine cancer and its therapy Am J Surg 1996172 172418-424
9 Rouse K Nwokedi E Woodliff JE Epstein J Klimberg VS Glutamine enhances selectivity of chemotherapy through changes in glutathione metabolism Ann Surg 1995 221420-426
10 Baxevanis CN Reclos GJ Grittapis AD et al Elevated PGE2 production by monocytes is responsible for the depressed levels of NKLAK cell function in patients with breast cancer Cancer 1993 12491-501
11 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 Res200222977-988
12 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
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
1 Anderson PM Schroeder G Skubitz KM Oral glutamine reduces the duration and severity of stomatitis after cytotoxic cancer chemotherapy Cancer 1998 83 1433-1439
2 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
3 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 1092 322-31
4 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 91669-74
5 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
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 101007st 2094-011-0729-3
7 Yoshida S Kaibara A Ishibashi N Shirouzu K Glutamine supplementation in cancer patients Nutrition 2001 17766-768
8 Klimberg SV McClellan Jl Glutamine cancer and its therapy Am J Surg 1996172 172418-424
9 Rouse K Nwokedi E Woodliff JE Epstein J Klimberg VS Glutamine enhances selectivity of chemotherapy through changes in glutathione metabolism Ann Surg 1995 221420-426
10 Baxevanis CN Reclos GJ Grittapis AD et al Elevated PGE2 production by monocytes is responsible for the depressed levels of NKLAK cell function in patients with breast cancer Cancer 1993 12491-501
11 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 Res200222977-988
12 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None