Head and Neck Cancer Clinical Trial
Official title:
Impacts of Oral Supplement With L-Glutamine on the Radiation-induced Toxicity and Nutritional Status of Head and Neck Cancer Patients Under Radiotherapy
The rapidly increasing mortality and incidence of oral cancer has become a public health
major problem in Taiwan. To date, the treatment of head and neck cancer mainly include
surgery, radiotherapy and chemotherapy. However, radiotherapy and chemotherapy might have an
influence on the patients' diet by causing dismal side effects, including nausea, vomiting,
pain, infection, dysorexia, allotriogeustia, oral ulceration and dysphagia, which make the
patients more difficult to absorb nutrients. In the previous study, the incidence of
malnutrition among the patients with cancer has been estimated at between 40 and 80%,
especially occurred in the patients with head and neck cancers and upper gastrointestinal
cancers.
In this study, the effect of supplement with L-Glutamine on the nutritional status and
radiation-induced toxicity of head and neck cancer patients will be evaluated to improve the
patients' quality of life when they are undergoing radiotherapy. When the head and neck
cancer patients undergoing radiotherapy, patients' instructions and nutrient intervention of
L-Glutamine are performed to maintain the patients' nutritional status and reduce the
patients' diet-related or other side effects caused by radiotherapy. It is anticipated that
head and neck cancer patients with surgery and radiotherapy intake with L-Glutamine might
decrease treatment-related side effects and hence improve their quality of life when they
are undergoing radiotherapy.
Status | Completed |
Enrollment | 59 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Histopathological diagnosis of malignant head and neck tumor. - able to open his or her mouth wider than the width of one finger during the assessment of oral mucositis. - Eastern Cooperative Oncology Group(ECOG)0-2 - complete radiotherapy (six to seven weeks with targets involving oral cavity or oropharynx) Exclusion Criteria: - History of previous radiotherapy. - diabetes or nephritic or hepatic problems. - serious infection or sepsis. - distant metastases |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Taiwan | Kaohsihung Medical University Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Kaohsiung Medical University Chung-Ho Memorial Hospital |
Taiwan,
Adelstein DJ, Saxton JP, Lavertu P, Rybicki LA, Esclamado RM, Wood BG, Strome M, Carroll MA. Maximizing local control and organ preservation in stage IV squamous cell head and neck cancer With hyperfractionated radiation and concurrent chemotherapy. J Cli — View Citation
Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. — View Citation
Buchman AL. Glutamine: is it a conditionally required nutrient for the human gastrointestinal system? J Am Coll Nutr. 1996 Jun;15(3):199-205. Review. — View Citation
Chattopadhyay S, Saha A, Azam M, Mukherjee A, Sur PK. Role of oral glutamine in alleviation and prevention of radiation-induced oral mucositis: A prospective randomized study. South Asian J Cancer. 2014 Jan;3(1):8-12. doi: 10.4103/2278-330X.126501. — View Citation
Choi K, Lee SS, Oh SJ, Lim SY, Lim SY, Jeon WK, Oh TY, Kim JW. The effect of oral glutamine on 5-fluorouracil/leucovorin-induced mucositis/stomatitis assessed by intestinal permeability test. Clin Nutr. 2007 Feb;26(1):57-62. — View Citation
Cockerham MB, Weinberger BB, Lerchie SB. Oral glutamine for the prevention of oral mucositis associated with high-dose paclitaxel and melphalan for autologous bone marrow transplantation. Ann Pharmacother. 2000 Mar;34(3):300-3. — View Citation
Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup.. Postoperative concurrent radiotherapy a — View Citation
Diestel CF, Marques RG, Lopes-Paulo F, Paiva D, Horst NL, Caetano CE, Portela MC. Role of L-glutamine and glycine supplementation on irradiated colonic wall. Int J Colorectal Dis. 2007 Dec;22(12):1523-9. — View Citation
Duncan M, Grant G. Oral and intestinal mucositis - causes and possible treatments. Aliment Pharmacol Ther. 2003 Nov 1;18(9):853-74. Review. — View Citation
Forastiere A, Koch W, Trotti A, Sidransky D. Head and neck cancer. N Engl J Med. 2001 Dec 27;345(26):1890-900. Review. Erratum in: N Engl J Med 2002 Mar 7;346(10):788. — View Citation
Fukui T, Itoh Y, Orihara M, Yoshizawa K, Takeda H, Kawada S, Yoshioka T. [Elental prevented and reduced oral mucositis during chemotherapy in patients esophageal cancer]. Gan To Kagaku Ryoho. 2011 Dec;38(13):2597-601. Japanese. — View Citation
Gibson RJ, Keefe DM, Lalla RV, Bateman E, Blijlevens N, Fijlstra M, King EE, Stringer AM, van der Velden WJ, Yazbeck R, Elad S, Bowen JM; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Onc — View Citation
Kozelsky TF, Meyers GE, Sloan JA, Shanahan TG, Dick SJ, Moore RL, Engeler GP, Frank AR, McKone TK, Urias RE, Pilepich MV, Novotny PJ, Martenson JA; North Central Cancer Treatment Group.. Phase III double-blind study of glutamine versus placebo for the pre — View Citation
Kucuktulu E, Guner A, Kahraman I, Topbas M, Kucuktulu U. The protective effects of glutamine on radiation-induced diarrhea. Support Care Cancer. 2013 Apr;21(4):1071-5. doi: 10.1007/s00520-012-1627-0. — View Citation
Kuhn KS, Muscaritoli M, Wischmeyer P, Stehle P. Glutamine as indispensable nutrient in oncology: experimental and clinical evidence. Eur J Nutr. 2010 Jun;49(4):197-210. doi: 10.1007/s00394-009-0082-2. Review. — View Citation
Lacey JM, Wilmore DW. Is glutamine a conditionally essential amino acid? Nutr Rev. 1990 Aug;48(8):297-309. Review. — View Citation
Mahdavi R, Faramarzi E, Mohammad-Zadeh M, Ghaeammaghami J, Jabbari MV. Consequences of radiotherapy on nutritional status, dietary intake, serum zinc and copper levels in patients with gastrointestinal tract and head and neck cancer. Saudi Med J. 2007 Mar — View Citation
Muscaritoli M, Micozzi A, Conversano L, Martino P, Petti MC, Cartoni C, Cascino A, Rossi-Fanelli F. Oral glutamine in the prevention of chemotherapy-induced gastrointestinal toxicity. Eur J Cancer. 1997 Feb;33(2):319-20. — View Citation
Ogata Y, Takeuchi M, Ishibashi N, Kibe S, Takahashi K, Uchida S, Murakami N, Yahara T, Shirouzu K. [Efficacy of Elental on prevention for chemotherapy-induced oral mucositis in colorectal cancer patients]. Gan To Kagaku Ryoho. 2012 Apr;39(4):583-7. Japane — View Citation
Ottery FD. Cancer cachexia: prevention, early diagnosis, and management. Cancer Pract. 1994 Mar-Apr;2(2):123-31. Review. Erratum in: Cancer Pract 1994 Jul-Aug;2(4):263. — View Citation
Ottery FD. Definition of standardized nutritional assessment and interventional pathways in oncology. Nutrition. 1996 Jan;12(1 Suppl):S15-9. Review. — View Citation
Paccagnella A, Morello M, Da Mosto MC, Baruffi C, Marcon ML, Gava A, Baggio V, Lamon S, Babare R, Rosti G, Giometto M, Boscolo-Rizzo P, Kiwanuka E, Tessarin M, Caregaro L, Marchiori C. Early nutritional intervention improves treatment tolerance and outcom — View Citation
Ravasco P, Monteiro Grillo I, Camilo M. Cancer wasting and quality of life react to early individualized nutritional counselling! Clin Nutr. 2007 Feb;26(1):7-15. Review. — View Citation
Savarese D, Al-Zoubi A, Boucher J. Glutamine for irinotecan diarrhea. J Clin Oncol. 2000 Jan;18(2):450-1. — View Citation
Savarese DM, Savy G, Vahdat L, Wischmeyer PE, Corey B. Prevention of chemotherapy and radiation toxicity with glutamine. Cancer Treat Rev. 2003 Dec;29(6):501-13. Review. — View Citation
Sharma R, Tobin P, Clarke SJ. Management of chemotherapy-induced nausea, vomiting, oral mucositis, and diarrhoea. Lancet Oncol. 2005 Feb;6(2):93-102. Review. — View Citation
Stokman MA, Spijkervet FK, Boezen HM, Schouten JP, Roodenburg JL, de Vries EG. Preventive intervention possibilities in radiotherapy- and chemotherapy-induced oral mucositis: results of meta-analyses. J Dent Res. 2006 Aug;85(8):690-700. Review. — View Citation
van Bokhorst-de van der Schuer, van Leeuwen PA, Kuik DJ, Klop WM, Sauerwein HP, Snow GB, Quak JJ. The impact of nutritional status on the prognoses of patients with advanced head and neck cancer. Cancer. 1999 Aug 1;86(3):519-27. — View Citation
Vidal-Casariego A, Calleja-Fernández A, Ballesteros-Pomar MD, Cano-Rodríguez I. Efficacy of glutamine in the prevention of oral mucositis and acute radiation-induced esophagitis: a retrospective study. Nutr Cancer. 2013;65(3):424-9. doi: 10.1080/01635581. — View Citation
Westin T, Jansson A, Zenckert C, Hällström T, Edström S. Mental depression is associated with malnutrition in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 1988 Dec;114(12):1449-53. — View Citation
Xue H, Sawyer MB, Field CJ, Dieleman LA, Baracos VE. Nutritional modulation of antitumor efficacy and diarrhea toxicity related to irinotecan chemotherapy in rats bearing the ward colon tumor. Clin Cancer Res. 2007 Dec 1;13(23):7146-54. — View Citation
Ziegler TR, Benfell K, Smith RJ, Young LS, Brown E, Ferrari-Baliviera E, Lowe DK, Wilmore DW. Safety and metabolic effects of L-glutamine administration in humans. JPEN J Parenter Enteral Nutr. 1990 Jul-Aug;14(4 Suppl):137S-146S. — View Citation
* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | grade of oral mucositis | Oral mucositis and radiation-induced dermatological toxicity were evaluated during and after treatment using the National Cancer Institute Common Toxicity Criteria version 3.0 (CTCAE v.3). The scoring was done as the patients went through the treatment by the attending physicians. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions. | once a week during radiotherapy and once after radiotherapy up to 8 weeks | No |
Primary | grade of neck dermatitis | Oral mucositis and radiation-induced dermatological toxicity were evaluated during and after treatment using the National Cancer Institute Common Toxicity Criteria version 3.0 (CTCAE v.3). The scoring was done as the patients went through the treatment by the attending physicians. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions. | once a week during radiotherapy and once after radiotherapy up to 8 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |