Trial · NCT01952847

Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis

NCT01952847, Phase 3, Terminated, M.D. Anderson Cancer Center; results first posted 2022-06-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis. Trials, record NCT01952847. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01952847

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis
NCT number: NCT01952847
Status: Terminated
Phases: Phase 3
Enrollment: 77 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Advanced Cancers
Interventions: Placebo, Glutamine, Questionnaires
First posted: 2013-09-30
Last updated: 2022-06-15
Results first posted: 2022-06-15

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Severity of Esophagitis for Radiation Therapy Patients	6 weeks	For esophagus radiation participants, the severity of esophagitis will be taken as the highest grade observed by week six. Wilcoxon rank sum test used to compare the ordered categories of esophagitis severity.
Primary	Severity of Oral Mucositis for mTOR Inhibitor Patients	6 months after start of mTOR inhibitor based treatment	For mTOR inhibitor patients, the severity of oral mucositis will be taken as the maximum grade observed during the 6-month study period. Wilcoxon rank sum test used to compare the ordered categories of mucositis severity.
Secondary	Quality of Life (QOL) in Esophagus Radiation Patients at Baseline	at baseline	The Quality of Life assessed by the MD Anderson Symptom Inventory for head and neck cancer (MDASI-HN). The 13 Core symptoms include dry mouth, fatigue, pain, disturbed sleep, drowsiness, feeling of being distressed, anorexia, sadness, numbness/tingling, dyspnea, difficulty remembering, nausea, and vomiting. The 9 Head and Neck symptoms include mouth sores, problems with taste, constipation, teeth/gum problems, skin pain, difficulty with voice, choking/coughing, difficulty swallowing, and problems with mucus specific to head and neck cancers. Total symptom severity include 24 core and Head and Neck symptoms together. Symptom interference asks patients about how their symptoms impact their daily functions. The severity of each symptom and symptom interference is rated on a numerical scale from 0 (symptom is absent) to 10 (worst possible severity)." Higher scores indicate a greater symptom burden.
Secondary	Quality of Life (QOL) in mTOR Inhibitor Patients at Baseline	at baseline	The Quality of Life assessed by the MD Anderson Symptom Inventory for head and neck cancer (MDASI-HN). The 13 Core symptoms include dry mouth, fatigue, pain, disturbed sleep, drowsiness, feeling of being distressed, anorexia, sadness, numbness/tingling, dyspnea, difficulty remembering, nausea, and vomiting. The 9 Head and Neck symptoms include mouth sores, problems with taste, constipation, teeth/gum problems, skin pain, difficulty with voice, choking/coughing, difficulty swallowing, and problems with mucus specific to head and neck cancers. Total symptom severity include 24 core and Head and Neck symptoms together. Symptom interference asks patients about how their symptoms impact their daily functions. The severity of each symptom and symptom interference is rated on a numerical scale from 0 (symptom is absent) to 10 (worst possible severity)." Higher scores indicate a greater symptom burden.
Secondary	Number of Participants With Esophagitis During 6 Weeks After Radiation Treatment Start	6 weeks	Participants in each arm received at least 60% of planned doses of the study drug (glutamine or placebo).
Secondary	Mucositis Incidence Per Participant During 6 Months After mTOR Inhibitor Treatment Start	6 months
Secondary	Grade 3 or Higher Esophagitis Incidence Per Participant During 6 Weeks After Radiation Start	6 weeks
Secondary	Grade 3 or Higher Mucositis Incidence Per Participant During 6 Months After Treatment Start	6 month
Secondary	Duration of Esophagitis After Radiation Treatment Start	From event starts to end of study visit
Secondary	Duration of Mucositis After mTOR Inhibitor Treatment Start	From event starts to end of study visit

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Severity of Esophagitis for Radiation Therapy Patients	6 weeks	Participants who took at least 60% of the planned doses of the study treatment and were evaluable per protocol definition.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Severity of Oral Mucositis for mTOR Inhibitor Patients	6 months after start of mTOR inhibitor based treatment	Evaluable Participants in the mTOR Inhibitor Cohort	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Quality of Life (QOL) in Esophagus Radiation Patients at Baseline	at baseline		score on a scale	MEDIAN
SECONDARY	Quality of Life (QOL) in mTOR Inhibitor Patients at Baseline	at baseline		score on a scale	MEDIAN
SECONDARY	Number of Participants With Esophagitis During 6 Weeks After Radiation Treatment Start	6 weeks	Evaluable participant	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mucositis Incidence Per Participant During 6 Months After mTOR Inhibitor Treatment Start	6 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Grade 3 or Higher Esophagitis Incidence Per Participant During 6 Weeks After Radiation Start	6 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Grade 3 or Higher Mucositis Incidence Per Participant During 6 Months After Treatment Start	6 month		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Esophagitis After Radiation Treatment Start	From event starts to end of study visit	Participants in the radiation cohort who experienced esophagitis.	weeks	MEDIAN
SECONDARY	Duration of Mucositis After mTOR Inhibitor Treatment Start	From event starts to end of study visit	Participants in the mTOR cohort who experienced mucositis.	weeks	MEDIAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group86

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Severity of Esophagitis for Radiation Therapy Patients	Radiation Therapy to Esophagus Patient Group - Glutamine	Grade 1	2	Participants
Severity of Esophagitis for Radiation Therapy Patients	Radiation Therapy to Esophagus Patient Group - Placebo	Grade 1	0	Participants
Severity of Esophagitis for Radiation Therapy Patients	Radiation Therapy to Esophagus Patient Group - Glutamine	Grade 2	5	Participants
Severity of Esophagitis for Radiation Therapy Patients	Radiation Therapy to Esophagus Patient Group - Placebo	Grade 2	8	Participants
Severity of Esophagitis for Radiation Therapy Patients	Radiation Therapy to Esophagus Patient Group - Glutamine	Grade 3	7	Participants
Severity of Esophagitis for Radiation Therapy Patients	Radiation Therapy to Esophagus Patient Group - Placebo	Grade 3	5	Participants
Severity of Esophagitis for Radiation Therapy Patients	Radiation Therapy to Esophagus Patient Group - Glutamine	Absent	5	Participants
Severity of Esophagitis for Radiation Therapy Patients	Radiation Therapy to Esophagus Patient Group - Placebo	Absent	6	Participants
Severity of Oral Mucositis for mTOR Inhibitor Patients	mTOR Inhibitor Patient Group - Glutamine	Grade 1	1	Participants
Severity of Oral Mucositis for mTOR Inhibitor Patients	mTOR Inhibitor Patient Group - Placebo	Grade 1	3	Participants

1 to 10 of 86Source ClinicalTrials.gov

See all 86 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Radiation Therapy to Esophagus Patient Group - Glutamine	27
Overall Study	STARTED	Radiation Therapy to Esophagus Patient Group - Placebo	26
Overall Study	STARTED	mTOR Inhibitor Patient Group - Glutamine	7
Overall Study	STARTED	mTOR Inhibitor Patient Group - Placebo	7
Overall Study	COMPLETED	Radiation Therapy to Esophagus Patient Group - Glutamine	25
Overall Study	COMPLETED	Radiation Therapy to Esophagus Patient Group - Placebo	24
Overall Study	COMPLETED	mTOR Inhibitor Patient Group - Glutamine	7
Overall Study	COMPLETED	mTOR Inhibitor Patient Group - Placebo	6
Overall Study	NOT COMPLETED	Radiation Therapy to Esophagus Patient Group - Glutamine	2
Overall Study	NOT COMPLETED	Radiation Therapy to Esophagus Patient Group - Placebo	2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events124

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Constipation	Gastrointestinal disorders	Radiation Therapy to Esophagus Patient Group - Glutamine	1	25
other	Constipation	Gastrointestinal disorders	Radiation Therapy to Esophagus Patient Group - Placebo	1	24
other	Constipation	Gastrointestinal disorders	mTOR Inhibitor Patient Group - Glutamine	0	7
other	Constipation	Gastrointestinal disorders	mTOR Inhibitor Patient Group - Placebo	0	6
other	Dehydration	Metabolism and nutrition disorders	Radiation Therapy to Esophagus Patient Group - Glutamine	0	25
other	Dehydration	Metabolism and nutrition disorders	Radiation Therapy to Esophagus Patient Group - Placebo	1	24
other	Dehydration	Metabolism and nutrition disorders	mTOR Inhibitor Patient Group - Glutamine	0	7
other	Dehydration	Metabolism and nutrition disorders	mTOR Inhibitor Patient Group - Placebo	0	6
other	Esophagitis	Gastrointestinal disorders	Radiation Therapy to Esophagus Patient Group - Glutamine	17	25
other	Esophagitis	Gastrointestinal disorders	Radiation Therapy to Esophagus Patient Group - Placebo	13	24

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Radiation Therapy to Esophagus Patient Group - Glutamine	6	25
Total, all-cause mortality	Radiation Therapy to Esophagus Patient Group - Placebo	2	24
Total, all-cause mortality	mTOR Inhibitor Patient Group - Glutamine	0	7
Total, all-cause mortality	mTOR Inhibitor Patient Group - Placebo	0	6
Total, other adverse events	Radiation Therapy to Esophagus Patient Group - Glutamine	20	25
Total, other adverse events	Radiation Therapy to Esophagus Patient Group - Placebo	15	24
Total, other adverse events	mTOR Inhibitor Patient Group - Glutamine	5	7
Total, other adverse events	mTOR Inhibitor Patient Group - Placebo	6	6
Total, serious adverse events	Radiation Therapy to Esophagus Patient Group - Glutamine	5	25
Total, serious adverse events	Radiation Therapy to Esophagus Patient Group - Placebo	3	24

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33580845	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Radiation Therapy to Esophagus Patient Group - Glutamine vs Radiation Therapy to Esophagus Patient Group - Placebo: Number of Participants With Cancer Treatment Interruptions Due to Esophagitis	Trial comparisons
mTOR Inhibitor Patient Group - Glutamine vs mTOR Inhibitor Patient Group - Placebo: Number of Participants With Cancer Treatment Interruptions Due to Mucositis	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01952847

GET https://conductscience.org/api/trials/v1/NCT01952847/results?page=2

API reference For AI assistants