Head and Neck CancerNCT03015077
Effects of Oral L-Glutamine in Head and Neck Cancer Patients During Radiotherapy
A study testing oral glutamine and Radiotherapy in people with Head and Neck Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- oral glutamine and Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- History of previous radiotherapy.
- diabetes or nephritic or hepatic problems.
- serious infection or sepsis.
- distant metastases
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- Written informed consent must be obtained before any study specific procedures are undertaken.
- The process of the experiment A. head and neck cancer patients with surgery and radiotherapy are identified in clinic at the Department of Dentistry and the Department of Radiotherapy in Kaohsiung Medical University Chung-Ho Memorial Hospital.
- Inform these patients about the value of this clinical trial in detail, and make sure that they understand all the meanings of each procedure in this clinical trial. Subsequently, the patients who are willing to participate in this study are enrolled after completing institutionally approved informed consent.
- In order to assess the effect of supplement with L-Glutamine on the nutritional status and diet of head and neck cancer patients with surgery and radiotherapy, the enrolled patients will be divided into two groups randomly. One group is supplied with 10 g L-Glutamine and 5 g maltodextrin; the other group is supplied with 15 g maltodextrin as control group. The patients of these two groups take their supplemental nutrients three times a day, respectively, in a period of time of 7 days before radiotherapy to 14 days after radiotherapy.
- Meanwhile, the research assistants will monitor the patients' condition carefully by recording their daily diet, nutritional status and side effects caused by radiotherapy at three specific time-points during the whole clinic trial program course.
- The monitor items of patients' nutritional status include the daily diet of patients before and after radiotherapy by recording 24 hr recall table and food frequency table,(b) the physical examination of height, weight, ideal weight, tricept skinfold (TSF), mid-arm circumference (MAC) and mid-arm muscle circumference (MAMC), (d) prognostic nutritional index (PNI), (e) biochemistry inspection assessment and (g) complete blood count (CBC).
- The monitor items of patients' diet-related side effects caused by radiotherapy include (a) oral mucositis and (b) neck dermatitis.
- The above-mentioned monitor items will be recorded carefully by the research assistants at three specific time-points during the whole clinic trial program course, which are initial point (7 days before radiotherapy), medium point (medium date during radiotherapy) and final point (14 days after radiotherapy).
- The research assistants will help the patients make an appointment, and let them visit the doctor on schedule. And make sure the patients actually follow up the suggestions and obey the instructions during the clinic trial.
- Conditions
- Head and Neck Cancer
- Being tested
- oral glutamine, placebo, Radiotherapy
- Keywords
- Glutamine
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral glutamineDietary supplement
L-Glutamine and maltodextrin are both nutritional supplements. In the glutamine arm: 10 g L-Glutamine and 5 g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.
placeboDietary supplement
in the placebo arm: 15 g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.
RadiotherapyRadiation
All patients undergo radiotherapy. 5 days a week. All patients had a dental evaluation for good oral hygiene prior to computed tomography simulation for radiotherapy. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. The course of radiation was initiated no more than 6 weeks after resection. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions.
| Study group | Role | What they receive |
|---|---|---|
| Glutamine | Active comparator | intake of 5g glutamine and 10g maltodextrin. Oral glutamine is a food additive issued by food and drug government in Taiwan with number 009929.L-Glutamine and maltodextrin are both nutritional supplements. In the glutamine arm: 10 g L-Glutamine and 5 g maltodextrin.
The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy. Receives: Dietary Supplement: oral glutamine; Radiation: Radiotherapy |
| placebo | Placebo comparator | intake of 15g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy. Receives: Dietary Supplement: placebo; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: once a week during radiotherapy and once after radiotherapy up to 8 weeks
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.
Measured: once a week during radiotherapy and once after radiotherapy up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJul 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015077
- Sponsor's protocol ID
- KMUHIRB-2014-12-01(II)
- Status last verified
- Feb 2015
- First submitted
- 11 Dec 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ottery FD. Cancer cachexia: prevention, early diagnosis, and management. Cancer Pract. 1994 Mar-Apr;2(2):123-31.
PubMed 8055014Adelstein 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 Clin Oncol. 2002 Mar 1;20(5):1405-10. doi: 10.1200/JCO.2002.20.5.1405.
PubMed 11870186Bauer 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. doi: 10.1038/sj.ejcn.1601412.
PubMed 12122555Cooper 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 and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.
PubMed 15128893Duncan M, Grant G. Oral and intestinal mucositis - causes and possible treatments. Aliment Pharmacol Ther. 2003 Nov 1;18(9):853-74. doi: 10.1046/j.1365-2036.2003.01784.x.
PubMed 14616150Forastiere A, Koch W, Trotti A, Sidransky D. Head and neck cancer. N Engl J Med. 2001 Dec 27;345(26):1890-900. doi: 10.1056/NEJMra001375. No abstract available.
PubMed 11756581Fukui 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.
PubMed 22189225Ogata 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. Japanese.
PubMed 22504682Ottery FD. Definition of standardized nutritional assessment and interventional pathways in oncology. Nutrition. 1996 Jan;12(1 Suppl):S15-9. doi: 10.1016/0899-9007(96)90011-8.
PubMed 8850213Paccagnella 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 outcomes in head and neck cancer patients undergoing concurrent chemoradiotherapy. Support Care Cancer. 2010 Jul;18(7):837-45. doi: 10.1007/s00520-009-0717-0. Epub 2009 Aug 30.
PubMed 19727846Ravasco 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. doi: 10.1016/j.clnu.2006.10.005. Epub 2006 Dec 12.
PubMed 17166637Vidal-Casariego A, Calleja-Fernandez A, Ballesteros-Pomar MD, Cano-Rodriguez 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: 10.1080/01635581.2013.765017.
PubMed 23530642Savarese 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. doi: 10.1016/s0305-7372(03)00133-6.
PubMed 14585260van 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.
PubMed 10430262Westin T, Jansson A, Zenckert C, Hallstrom T, Edstrom 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. doi: 10.1001/archotol.1988.01860240099032.
PubMed 3190874
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03015077
- Acronym / sponsor ID
- KMUHIRB-2014-12-01(II)
- Conditions
- Head and Neck Cancer
- Keywords
- Glutamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Written informed consent must be obtained before any study specific procedures are undertaken.
- The process of the experiment A. head and neck cancer patients with surgery and radiotherapy are identified in clinic at the Department of Dentistry and the Department of Radiotherapy in Kaohsiung Medical University Chung-Ho Memorial Hospital.
- Inform these patients about the value of this clinical trial in detail, and make sure that they understand all the meanings of each procedure in this clinical trial. Subsequently, the patients who are willing to participate in this study are enrolled after completing institutionally approved informed consent.
- In order to assess the effect of supplement with L-Glutamine on the nutritional status and diet of head and neck cancer patients with surgery and radiotherapy, the enrolled patients will be divided into two groups randomly. One group is supplied with 10 g L-Glutamine and 5 g maltodextrin; the other group is supplied with 15 g maltodextrin as control group. The patients of these two groups take their supplemental nutrients three times a day, respectively, in a period of time of 7 days before radiotherapy to 14 days after radiotherapy.
- Meanwhile, the research assistants will monitor the patients' condition carefully by recording their daily diet, nutritional status and side effects caused by radiotherapy at three specific time-points during the whole clinic trial program course.
- The monitor items of patients' nutritional status include the daily diet of patients before and after radiotherapy by recording 24 hr recall table and food frequency table,(b) the physical examination of height, weight, ideal weight, tricept skinfold (TSF), mid-arm circumference (MAC) and mid-arm muscle circumference (MAMC), (d) prognostic nutritional index (PNI), (e) biochemistry inspection assessment and (g) complete blood count (CBC).
- The monitor items of patients' diet-related side effects caused by radiotherapy include (a) oral mucositis and (b) neck dermatitis.
- The above-mentioned monitor items will be recorded carefully by the research assistants at three specific time-points during the whole clinic trial program course, which are initial point (7 days before radiotherapy), medium point (medium date during radiotherapy) and final point (14 days after radiotherapy).
- The research assistants will help the patients make an appointment, and let them visit the doctor on schedule. And make sure the patients actually follow up the suggestions and obey the instructions during the clinic trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine | Active comparator | Dietary Supplement: oral glutamine, Radiation: Radiotherapyintake of 5g glutamine and 10g maltodextrin. Oral glutamine is a food additive issued by food and drug government in Taiwan with number 009929.L-Glutamine and maltodextrin are both nutritional supplements. In the glutamine arm: 10 g L-Glutamine and 5 g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy. |
| placebo | Placebo comparator | Dietary Supplement: placebo, Radiation: Radiotherapyintake of 15g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- History of previous radiotherapy.
- diabetes or nephritic or hepatic problems.
- serious infection or sepsis.
- distant metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral glutamineL-Glutamine and maltodextrin are both nutritional supplements. In the glutamine arm: 10 g L-Glutamine and 5 g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy. | Dietary supplement | Glutamine |
| placeboin the placebo arm: 15 g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy. | Dietary supplement | placebo |
| RadiotherapyAll patients undergo radiotherapy. 5 days a week. All patients had a dental evaluation for good oral hygiene prior to computed tomography simulation for radiotherapy. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. The course of radiation was initiated no more than 6 weeks after resection. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions. | Radiation | Glutamine, placebo |
Primary outcome
grade of oral mucositis
Time frame: once a week during radiotherapy and once after radiotherapy up to 8 weeks
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.
grade of neck dermatitis
Time frame: once a week during radiotherapy and once after radiotherapy up to 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Background: PubMed 8055014Ottery FD. Cancer cachexia: prevention, early diagnosis, and management. Cancer Pract. 1994 Mar-Apr;2(2):123-31.
- Results publication: PubMed 11870186Adelstein 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 Clin Oncol. 2002 Mar 1;20(5):1405-10. doi: 10.1200/JCO.2002.20.5.1405.
- Results publication: PubMed 12122555Bauer 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. doi: 10.1038/sj.ejcn.1601412.
- Results publication: PubMed 15128893Cooper 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 and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.
- Results publication: PubMed 14616150Duncan M, Grant G. Oral and intestinal mucositis - causes and possible treatments. Aliment Pharmacol Ther. 2003 Nov 1;18(9):853-74. doi: 10.1046/j.1365-2036.2003.01784.x.
- Results publication: PubMed 11756581Forastiere A, Koch W, Trotti A, Sidransky D. Head and neck cancer. N Engl J Med. 2001 Dec 27;345(26):1890-900. doi: 10.1056/NEJMra001375. No abstract available.
- Results publication: PubMed 22189225Fukui 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.
- Results publication: PubMed 22504682Ogata 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. Japanese.
- Results publication: PubMed 8850213Ottery FD. Definition of standardized nutritional assessment and interventional pathways in oncology. Nutrition. 1996 Jan;12(1 Suppl):S15-9. doi: 10.1016/0899-9007(96)90011-8.
- Results publication: PubMed 19727846Paccagnella 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 outcomes in head and neck cancer patients undergoing concurrent chemoradiotherapy. Support Care Cancer. 2010 Jul;18(7):837-45. doi: 10.1007/s00520-009-0717-0. Epub 2009 Aug 30.
- Results publication: PubMed 17166637Ravasco 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. doi: 10.1016/j.clnu.2006.10.005. Epub 2006 Dec 12.
- Results publication: PubMed 23530642Vidal-Casariego A, Calleja-Fernandez A, Ballesteros-Pomar MD, Cano-Rodriguez 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: 10.1080/01635581.2013.765017.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral glutamine and Radiotherapy in people with Head and Neck Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grade of oral mucositis (time frame: once a week during radiotherapy and once after radiotherapy up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03015077, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.