Trial · NCT01198145
Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy
NCT01198145, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy. Trials, record NCT01198145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01198145
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy
- NCT number
- NCT01198145
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 87 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Diarrhea, Gastrointestinal Complications, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- sulfasalazine, placebo
- First posted
- 2010-09-09
- Last updated
- 2020-05-12
- Results first posted
- 2017-04-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | During radiation therapy and up to 6 weeks post radiation therapy | The primary endpoint for this study is the maximal severity of diarrhea toxicity. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening as measured by the CTCAE version 4.0. Assessments were recorded during the course of RT and for 6 weeks following RT. The table below represents the worst graded diarrhea for each patient. A two-sided Wilcoxon rank-sum test will be used to test the equality of the distributions of maximum diarrhea severity grades between the two treatment arms. |
| Secondary | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | During radiation therapy and up to 6 weeks post radiation therapy | The maximal severity of each of 5 different adverse even types (Tenesmus, Abdominal Pain, Constipation, Diarrhea, and Rectal Bleeding) were collected as a secondary endpoint. Severity of the events was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. Adverse events were assessed during the course of RT and for 6 weeks following RT. The table below represents the worst grade for each patient for each type. Two-sided chi-square tests will be used to compare each percentage variable between treatment arms for each event type. |
| Secondary | Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT | During radiation therapy and up to 6 weeks post radiation therapy | For each patient, an Area Under the Curve (AUC) summary statistic will be calculated taking into account the individual severity of diarrhea toxicity over time. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. The curve was constructed using weekly assessments during and after RT. A separate analysis was done during the course of RT and every week for 6 weeks following RT. |
| Secondary | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | During radiation therapy and up to 6 weeks post radiation therapy | Tenesmus, Abdominal pain, constipation, diarrhea and hemorrhaging were assessed during RT and up to 6 weeks after RT. Severity of these events were graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. For each patient, an average score for each outcome variable during and after RT calculated as follows: The sum of all severity scores for that variable divided by the number of severity scores for that variable recorded for the patient during the course of RT and for 6 weeks following RT. |
| Secondary | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | During radiation therapy and up to 6 weeks post radiation therapy | The number of patients that reported any grade 1 or higher adverse event was divided by the total number of patients evaluated. The analysis was done separately for each of the 5 outcomes and separately during RT and after RT. |
| Secondary | Percent of Patients in Each Arm That Recorded "Yes" to Each of Questions 2-10 on the Bowel Function Questionnaire | Up to 6 weeks post radiation therapy | Questions that were used in this analysis: 2\. Have you had a problem causing you to get up at night to have a bowel movement? 3. Have you had a problem causing you to lose control of your bowel movements? 4. Have you had a problem causing you to have a bowel movement within 30 minutes of a prior bowel movement? 5. Have you had to wear protective clothing or a pad in case you lost control of a bowel movement? 6. Have you had a problem causing you to be unable to tell the difference between stool and gas? 7. Have you had a problem causing you to have stools that are liquid? 1=yes 2=no q08 8. Have you found that once you feel the urge to have a bowel movement, you must do so within 15 minutes to avoid an accident? 9. Have you had cramping with a bowel movement? 10. Have you had blood in your bowel movement? |
| Secondary | Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications. | Up to 24 months post radiotherapy | The number of patients reporting the use of anti-diarrheal medications divided by the number of patients evaluated for this endpoint. |
| Secondary | Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue | Up to 6 weeks post radiotherapy | For each arm, the percentage of patients experience clinically significant deficits in overall QOL and fatigue as indicated by a score of 5 or lower on the 0-10 scale. The analysis was done using the questionnaire that was completed during the first week of radiotherapy (RT) and 6 weeks after RT. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | During radiation therapy and up to 6 weeks post radiation therapy | Two patients in Arm I and one patient from Arm II were not included in the baseline analysis nor the endpoint analyses due to cancellations and protocol violations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | During radiation therapy and up to 6 weeks post radiation therapy | Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used for the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT | During radiation therapy and up to 6 weeks post radiation therapy | Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data. | grade*week | MEAN |
| SECONDARY | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | During radiation therapy and up to 6 weeks post radiation therapy | Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data. | Average Grade of Event | MEAN |
| SECONDARY | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | During radiation therapy and up to 6 weeks post radiation therapy | Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data. | percentage of participants | NUMBER |
| SECONDARY | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | Up to 6 weeks post radiation therapy | All patients that completed the questionnaire were included in the analysis. Questionnaires used were completed during the last week during RT and 6 weeks after RT. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications. | Up to 24 months post radiotherapy | Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue | Up to 6 weeks post radiotherapy | All completed QOL questionnaires were included in the analysis. Questionnaires used were completed during the first week during RT and 6 weeks after RT. From Arm I, 41 patients completed questionnaires, 39 during and 26 after RT. For Arm II, 42 patients completed the questions, 40 during and 29 after RT. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group196
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Arm I: Sulfasalazine | Grade 0 | 10 | Participants | |
| Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Arm II: Placebo | Grade 0 | 10 | Participants | |
| Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Arm I: Sulfasalazine | Grade 1 | 13 | Participants | |
| Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Arm II: Placebo | Grade 1 | 15 | Participants | |
| Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Arm I: Sulfasalazine | Grade 2 | 8 | Participants | |
| Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Arm II: Placebo | Grade 2 | 13 | Participants | |
| Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Arm I: Sulfasalazine | Grade 3 | 10 | Participants | |
| Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Arm II: Placebo | Grade 3 | 4 | Participants | |
| Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Arm I: Sulfasalazine | Grade 4 | 1 | Participants | |
| Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Arm II: Placebo | Grade 4 | 0 | Participants |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I: Sulfasalazine | 44 | |
| Overall Study | STARTED | Arm II: Placebo | 43 | |
| Overall Study | COMPLETED | Arm I: Sulfasalazine | 43 | |
| Overall Study | COMPLETED | Arm II: Placebo | 42 | |
| Overall Study | NOT COMPLETED | Arm I: Sulfasalazine | 1 | |
| Overall Study | NOT COMPLETED | Arm II: Placebo | 1 |
Source ClinicalTrials.gov
Adverse events88
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 | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm I: Sulfasalazine | 15 | 43 | 53 |
| other | Anemia | Blood and lymphatic system disorders | Arm II: Placebo | 17 | 42 | 82 |
| other | Sick sinus syndrome | Cardiac disorders | Arm I: Sulfasalazine | 1 | 43 | 2 |
| other | Sick sinus syndrome | Cardiac disorders | Arm II: Placebo | 0 | 42 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm I: Sulfasalazine | 15 | 43 | 56 |
| other | Abdominal pain | Gastrointestinal disorders | Arm II: Placebo | 22 | 42 | 68 |
| other | Anal pain | Gastrointestinal disorders | Arm I: Sulfasalazine | 1 | 43 | 1 |
| other | Anal pain | Gastrointestinal disorders | Arm II: Placebo | 0 | 42 | 0 |
| other | Constipation | Gastrointestinal disorders | Arm I: Sulfasalazine | 15 | 43 | 40 |
| other | Constipation | Gastrointestinal disorders | Arm II: Placebo | 15 | 42 | 57 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I: Sulfasalazine | ||
| Total, all-cause mortality | Arm II: Placebo | ||
| Total, other adverse events | Arm I: Sulfasalazine | 42 | 43 |
| Total, other adverse events | Arm II: Placebo | 40 | 42 |
| Total, serious adverse events | Arm I: Sulfasalazine | 1 | 43 |
| Total, serious adverse events | Arm II: Placebo | 2 | 42 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27354129 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I: Sulfasalazine vs Arm II: Placebo: serious adverse events |
Source 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.
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/NCT01198145
GET https://conductscience.org/api/trials/v1/NCT01198145/results?page=2