Trial · NCT01952847
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| 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 | |
| Secondary | Time to Esophagitis on the Radiation Cohort Onset | From radiation starts to end of study visit | |
| Secondary | Proportion of Participants Who Were Mucositis-Free at 18.3 Weeks | 18.3 weeks | Proportion of participants who were free of Mucositis at 18.3 weeks.. |
| Secondary | Number of Participants With Cancer Treatment Interruptions Due to Esophagitis | From radiation treatment start to end of study visit, approximately 6 months | |
| Secondary | Number of Participants With Cancer Treatment Interruptions Due to Mucositis | 6 months after start of mTOR inhibitor based treatment | |
| Secondary | Radiation Cohort Participant Weight Change From Baseline to End of Study | from baseline to 6 months post radiation therapy | Investigators recorded weight at baseline to the end of treatment with glutamine/placebo. Weight loss calculated at each study assessment visit using the Wilcoxon rank sum test. |
| Secondary | mTOR Inhibitor Cohort Participant Weight Change From Baseline to End of Study | baseline, weekly during Cycle 1, and Day 1 of Cycle 2 and beyond, and 4 weeks and 6 months after the last dose of the mTOR inhibitor | Investigators recorded the weight at baseline and the end of the study. Weight loss calculated at each study assessment visit using the Wilcoxon rank sum test. |
| Secondary | Summary of Adverse Events by Grade and Relationship - Radiation Cohort | weekly during radiation, 1 month and 6 months post radiation therapy until resolution, stabilization, death, loss to follow up, or commencement of new therapy | CTCAE version 4.03 used to access the adverse events. Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated Grade 3 Severely altered eating/swallowing; tube feeding, TPN or hospitalization indicated. Total toxicity-evaluable is the total number of participants who had at least one dose of glutamine or placebo. |
| Secondary | Summary of Adverse Events by Grade and Relationship - mTOR Inhibitor Cohort | weekly during Cycle 1, and Day 1 of Cycle 2 and beyond, and 4 weeks and 6 months after the last dose of the mTOR inhibitor until resolution, stabilization, death, loss to follow up, or commencement of new therapy | CTCAE version 4.03 used to access the adverse events. Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated Grade 3 Severely altered eating/swallowing; tube feeding, TPN or hospitalization indicated. Total toxicity-evaluable is the total number of participants who had at least one dose of glutamine or placebo |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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