Biopsy Confirmed Head and Neck Cancer and Tumors of the ChestNCT05054517
Oral Glutamine and Thoracic/Upper Aerodigestive Tumors Radiation Toxicity
An observational study of Biopsy Confirmed Head and Neck Cancer and Tumors of the Chest, run by National and Kapodistrian University of Athens.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biopsy Confirmed Head and Neck Cancer and Tumors of the Chest
- What is being tested?
- Glutamine
- Type of treatment
- Pill or oral medicine
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Jan 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 72 patients with biopsy-diagnosed T\&UAM were prospectively recruited. The mean age of patients was 65.6 ± 1.2 years, ranging between 54 and 77 years. Most participants were male (n=54, 75%).
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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
Read more
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.
- Being tested
- Glutamine
- Keywords
- Glutamine; chest tumors; lung cancer; head and neck cancer; clinical studies; human subjects
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDietary supplement
Oral Supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints were the incidence of grade 2 or greater in the observed toxicities, weight loss and the need for analgesic therapy
Measured: one month
Secondary outcomes (1)
The secondary endpoint was the length of the irradiated esophagus from radiotherapy (RT) treatment planning correlated with the use of opioids as analgesics.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study startApr 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biopsy Confirmed Head and Neck Cancer and Tumors of the ChestStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos Drakoulis, MD, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054517
- Sponsor's protocol ID
- Athens Medical 2281/26-04-2013
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no availability of any data
Publications
Papanikolopoulou A, Syrigos N, Vini L, Papasavva M, Lazopoulos G, Kteniadakis S, Spandidos DA, Charpidou A, Drakoulis N. Use of oral glutamine in radiation-induced adverse effects in patients with thoracic and upper aerodigestive malignancies: Results of a prospective observational study. Oncol Lett. 2022 Jan;23(1):19. doi: 10.3892/ol.2021.13137. Epub 2021 Nov 16.
PubMed 34858523
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Oral Glutamine in Patients With Thoracic and Upper Aerodigestive Malignancies Who Undergo Radiotherapy: Results of a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05054517
- Acronym / sponsor ID
- Athens Medical 2281/26-04-2013
- Keywords
- Glutamine; chest tumors; lung cancer; head and neck cancer; clinical studies; human subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Sep 2021 (actual)
- 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 72 patients with biopsy-diagnosed T\&UAM were prospectively recruited. The mean age of patients was 65.6 ± 1.2 years, ranging between 54 and 77 years. Most participants were male (n=54, 75%).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| GlutamineOral Supplement | Dietary supplement | – |
Primary outcome
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
1 secondary outcome
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
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 23 Sep 2021.
- Derived from this study: PubMed 34858523Papanikolopoulou A, Syrigos N, Vini L, Papasavva M, Lazopoulos G, Kteniadakis S, Spandidos DA, Charpidou A, Drakoulis N. Use of oral glutamine in radiation-induced adverse effects in patients with thoracic and upper aerodigestive malignancies: Results of a prospective observational study. Oncol Lett. 2022 Jan;23(1):19. doi: 10.3892/ol.2021.13137. Epub 2021 Nov 16.
- Individual participant dataSharing planned: No. no availability of any data
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Biopsy Confirmed Head and Neck Cancer and Tumors of the Chest, run by National and Kapodistrian University of Athens.
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 1 inclusion and 1 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 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
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). 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 NCT05054517, which also lists 1 linked publication.
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 23 Sep 2021.