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Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01198145
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : April 4, 2017
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Diarrhea
Gastrointestinal Complications
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Drug: sulfasalazine
Other: placebo
Enrollment 87
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I: Sulfasalazine Arm II: Placebo
Hide Arm/Group Description Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

>

> placebo: Given orally

Period Title: Overall Study
Started 44 43
Completed 43 42
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Arm I: Sulfasalazine Arm II: Placebo Total
Hide Arm/Group Description Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy. >

> placebo: Given orally

Total of all reporting groups
Overall Number of Baseline Participants 42 42 84
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 84 participants
59
(37 to 84)
56.5
(37 to 81)
58
(37 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Female
15
  35.7%
18
  42.9%
33
  39.3%
Male
27
  64.3%
24
  57.1%
51
  60.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 42 participants 84 participants
42 42 84
1.Primary Outcome
Title Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT)
Hide Description

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.

Time Frame During radiation therapy and up to 6 weeks post radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I: Sulfasalazine Arm II: Placebo
Hide Arm/Group Description:
Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

>

> placebo: Given orally

Overall Number of Participants Analyzed 42 42
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 0
10
  23.8%
10
  23.8%
Grade 1
13
  31.0%
15
  35.7%
Grade 2
8
  19.0%
13
  31.0%
Grade 3
10
  23.8%
4
   9.5%
Grade 4
1
   2.4%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I: Sulfasalazine, Arm II: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT
Hide Description

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.

Time Frame During radiation therapy and up to 6 weeks post radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I: Sulfasalazine Arm II: Placebo
Hide Arm/Group Description:
Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Overall Number of Participants Analyzed 42 42
Measure Type: Count of Participants
Unit of Measure: Participants
Tenesmus during RT Number Analyzed 42 participants 42 participants
Grade 0
27
  64.3%
30
  71.4%
Grade 1
6
  14.3%
9
  21.4%
Grade 2
7
  16.7%
3
   7.1%
Grade 3
2
   4.8%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Tenesmus after RT Number Analyzed 23 participants 29 participants
Grade 0
18
  78.3%
21
  72.4%
Grade 1
5
  21.7%
7
  24.1%
Grade 2
0
   0.0%
1
   3.4%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Abdominal pain during RT Number Analyzed 42 participants 42 participants
Grade 0
22
  52.4%
26
  61.9%
Grade 1
14
  33.3%
12
  28.6%
Grade 2
3
   7.1%
4
   9.5%
Grade 3
3
   7.1%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Abdominal pain after RT Number Analyzed 25 participants 29 participants
Grade 0
17
  68.0%
24
  82.8%
Grade 1
8
  32.0%
2
   6.9%
Grade 2
0
   0.0%
3
  10.3%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Constipation during RT Number Analyzed 42 participants 42 participants
Grade 0
26
  61.9%
27
  64.3%
Grade 1
12
  28.6%
13
  31.0%
Grade 2
4
   9.5%
2
   4.8%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Constipation after RT Number Analyzed 25 participants 29 participants
Grade 0
19
  76.0%
22
  75.9%
Grade 1
6
  24.0%
6
  20.7%
Grade 2
0
   0.0%
1
   3.4%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Diarrhea during RT Number Analyzed 42 participants 42 participants
Grade 0
10
  23.8%
11
  26.2%
Grade 1
13
  31.0%
14
  33.3%
Grade 2
9
  21.4%
13
  31.0%
Grade 3
9
  21.4%
4
   9.5%
Grade 4
1
   2.4%
0
   0.0%
Diarrhea after RT Number Analyzed 25 participants 29 participants
Grade 0
11
  44.0%
14
  48.3%
Grade 1
12
  48.0%
10
  34.5%
Grade 2
2
   8.0%
3
  10.3%
Grade 3
0
   0.0%
2
   6.9%
Grade 4
0
   0.0%
0
   0.0%
Rectal bleeding during RT Number Analyzed 42 participants 42 participants
Grade 0
26
  61.9%
22
  52.4%
Grade 1
16
  38.1%
20
  47.6%
Grade 2
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Rectal bleeding after RT Number Analyzed 25 participants 29 participants
Grade 0
20
  80.0%
27
  93.1%
Grade 1
5
  20.0%
2
   6.9%
Grade 2
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I: Sulfasalazine, Arm II: Placebo
Comments Comparing Tenesmus During RT
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I: Sulfasalazine, Arm II: Placebo
Comments Comparing Tenesmus after RT
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I: Sulfasalazine, Arm II: Placebo
Comments Comparing abdominal pain during RT.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm I: Sulfasalazine, Arm II: Placebo
Comments Comparing abdominal pain after RT
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Arm I: Sulfasalazine, Arm II: Placebo
Comments Comparing constipation during RT
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Arm I: Sulfasalazine, Arm II: Placebo
Comments Comparing constipation after RT
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Arm I: Sulfasalazine, Arm II: Placebo
Comments Comparing diarrhea during RT
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Arm I: Sulfasalazine, Arm II: Placebo
Comments Comparing diarrhea after RT
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Arm I: Sulfasalazine, Arm II: Placebo
Comments Comparing rectal bleeding during RT
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Arm I: Sulfasalazine, Arm II: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT
Hide Description 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.
Time Frame During radiation therapy and up to 6 weeks post radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I: Sulfasalazine Arm II: Placebo
Hide Arm/Group Description:
Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Overall Number of Participants Analyzed 42 42
Mean (Standard Deviation)
Unit of Measure: grade*week
During RT Number Analyzed 42 participants 42 participants
4.0  (3.9) 3.3  (3.0)
After RT Number Analyzed 29 participants 25 participants
1.2  (1.7) 1.3  (2.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I: Sulfasalazine, Arm II: Placebo
Comments Result comparing Arm I and Arm II during RT.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I: Sulfasalazine, Arm II: Placebo
Comments Result comparing Arm I and Arm II after RT.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0
Hide Description 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.
Time Frame During radiation therapy and up to 6 weeks post radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I: Sulfasalazine Arm II: Placebo
Hide Arm/Group Description:
Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Overall Number of Participants Analyzed 42 42
Mean (Standard Deviation)
Unit of Measure: Average Grade of Event
Tenesmus during RT Number Analyzed 42 participants 42 participants
0.2  (0.4) 0.1  (0.2)
Tenesmus after RT Number Analyzed 23 participants 29 participants
0.1  (0.2) 0.1  (0.4)
Abdominal pain during RT Number Analyzed 42 participants 42 participants
0.3  (0.4) 0.2  (0.3)
Abdominal pain after RT Number Analyzed 25 participants 29 participants
0.2  (0.3) 0.2  (0.4)
Constipation during RT Number Analyzed 42 participants 42 participants
0.2  (0.3) 0.2  (0.3)
Constipation after RT Number Analyzed 25 participants 29 participants
0.1  (0.3) 0.1  (0.2)
Diarrhea during RT Number Analyzed 42 participants 42 participants
0.8  (0.7) 0.6  (0.6)
Diarrhea after RT Number Analyzed 25 participants 29 participants
0.3  (0.4) 0.3  (0.4)
Rectal bleeding during RT Number Analyzed 42 participants 42 participants
0.2  (0.3) 0.2  (0.3)
Rectal bleeding after RT Number Analyzed 25 participants 29 participants
0.1  (0.3) 0.1  (0.2)
5.Secondary Outcome
Title Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT
Hide Description 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.
Time Frame During radiation therapy and up to 6 weeks post radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I: Sulfasalazine Arm II: Placebo
Hide Arm/Group Description:
Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Overall Number of Participants Analyzed 42 42
Measure Type: Number
Unit of Measure: percentage of participants
Tenesmus during RT Number Analyzed 42 participants 42 participants
35.7 28.6
Tenesmus after RT Number Analyzed 23 participants 29 participants
11.9 19.1
Abdominal pain during RT Number Analyzed 42 participants 42 participants
47.6 38.1
Abdominal pain after RT Number Analyzed 25 participants 29 participants
19.1 11.9
Constipation during RT Number Analyzed 42 participants 42 participants
38.1 35.7
Constipation after RT Number Analyzed 25 participants 29 participants
14.3 16.7
Diarrhea during RT Number Analyzed 42 participants 42 participants
76.2 73.8
Diarrhea after RT Number Analyzed 25 participants 29 participants
33.3 35.7
Rectal bleeding during RT Number Analyzed 42 participants 42 participants
38.1 47.6
Rectal bleeding after RT Number Analyzed 25 participants 29 participants
11.9 4.8
6.Secondary Outcome
Title Percent of Patients in Each Arm That Recorded "Yes" to Each of Questions 2-10 on the Bowel Function Questionnaire
Hide Description

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?

Time Frame Up to 6 weeks post radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I: Sulfasalazine Arm II: Placebo
Hide Arm/Group Description:
Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Overall Number of Participants Analyzed 39 41
Measure Type: Number
Unit of Measure: percentage of participants
During RT : Q2 Number Analyzed 28 participants 32 participants
19 10
During RT : Q3 Number Analyzed 28 participants 32 participants
11 10
During RT : Q4 Number Analyzed 28 participants 32 participants
33 33
During RT : Q5 Number Analyzed 28 participants 32 participants
7 0
During RT : Q6 Number Analyzed 28 participants 32 participants
26 23
During RT : Q7 Number Analyzed 28 participants 32 participants
11 20
During RT : Q8 Number Analyzed 28 participants 32 participants
44 43
During RT : Q9 Number Analyzed 28 participants 32 participants
4 17
During RT : Q10 Number Analyzed 28 participants 32 participants
7 7
After RT : Q2 Number Analyzed 39 participants 41 participants
39 27
After RT : Q3 Number Analyzed 39 participants 41 participants
24 22
After RT : Q4 Number Analyzed 39 participants 41 participants
55 56
After RT : Q5 Number Analyzed 39 participants 41 participants
18 12
After RT : Q6 Number Analyzed 39 participants 41 participants
37 46
After RT : Q7 Number Analyzed 39 participants 41 participants
37 37
After RT : Q8 Number Analyzed 39 participants 41 participants
70 61
After RT : Q9 Number Analyzed 39 participants 41 participants
34 34
After RT : Q10 Number Analyzed 39 participants 41 participants
50 29
7.Secondary Outcome
Title Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications.
Hide Description The number of patients reporting the use of anti-diarrheal medications divided by the number of patients evaluated for this endpoint.
Time Frame Up to 24 months post radiotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations.
Arm/Group Title Arm I: Sulfasalazine Arm II: Placebo
Hide Arm/Group Description:
Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Overall Number of Participants Analyzed 42 42
Measure Type: Number
Unit of Measure: percentage of participants
48.7 28.6
8.Secondary Outcome
Title Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue
Hide Description 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.
Time Frame Up to 6 weeks post radiotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I: Sulfasalazine Arm II: Placebo
Hide Arm/Group Description:
Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
Overall Number of Participants Analyzed 41 42
Measure Type: Number
Unit of Measure: percentage of participants
During RT Number Analyzed 39 participants 40 participants
17.9 7.5
After RT Number Analyzed 26 participants 29 participants
26.9 27.6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I: Sulfasalazine Arm II: Placebo
Hide Arm/Group Description Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy. placebo: Given orally
All-Cause Mortality
Arm I: Sulfasalazine Arm II: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm I: Sulfasalazine Arm II: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/43 (2.33%)      2/42 (4.76%)    
Blood and lymphatic system disorders     
Anemia  1  0/43 (0.00%)  0 1/42 (2.38%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/43 (2.33%)  1 0/42 (0.00%)  0
Constipation  1  0/43 (0.00%)  0 1/42 (2.38%)  1
Gastrointestinal disorders - Other, specify  1  0/43 (0.00%)  0 1/42 (2.38%)  1
Tenesmus  1  0/43 (0.00%)  0 1/42 (2.38%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I: Sulfasalazine Arm II: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/43 (97.67%)      40/42 (95.24%)    
Blood and lymphatic system disorders     
Anemia  1  15/43 (34.88%)  53 17/42 (40.48%)  82
Cardiac disorders     
Sick sinus syndrome  1  1/43 (2.33%)  2 0/42 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  15/43 (34.88%)  56 22/42 (52.38%)  68
Anal pain  1  1/43 (2.33%)  1 0/42 (0.00%)  0
Constipation  1  15/43 (34.88%)  40 15/42 (35.71%)  57
Diarrhea  1  33/43 (76.74%)  150 32/42 (76.19%)  154
Dyspepsia  1  1/43 (2.33%)  2 1/42 (2.38%)  1
Gastrointestinal disorders - Other, specify  1  0/43 (0.00%)  0 1/42 (2.38%)  1
Lower gastrointestinal hemorrhage  1  17/43 (39.53%)  44 15/42 (35.71%)  40
Mucositis oral  1  1/43 (2.33%)  1 0/42 (0.00%)  0
Nausea  1  2/43 (4.65%)  5 2/42 (4.76%)  2
Rectal pain  1  2/43 (4.65%)  6 0/42 (0.00%)  0
Tenesmus  1  17/43 (39.53%)  43 16/42 (38.10%)  49
General disorders     
Fatigue  1  3/43 (6.98%)  9 2/42 (4.76%)  6
Immune system disorders     
Allergic reaction  1  0/43 (0.00%)  0 1/42 (2.38%)  1
Infections and infestations     
Abdominal infection  1  1/43 (2.33%)  1 0/42 (0.00%)  0
Rash pustular  1  1/43 (2.33%)  2 0/42 (0.00%)  0
Vaginal infection  1  1/43 (2.33%)  1 1/42 (2.38%)  2
Injury, poisoning and procedural complications     
Dermatitis radiation  1  1/43 (2.33%)  1 1/42 (2.38%)  3
Investigations     
Lymphocyte count decreased  1  2/43 (4.65%)  2 7/42 (16.67%)  33
Neutrophil count decreased  1  4/43 (9.30%)  5 6/42 (14.29%)  14
Platelet count decreased  1  4/43 (9.30%)  11 8/42 (19.05%)  15
White blood cell decreased  1  8/43 (18.60%)  22 18/42 (42.86%)  57
Metabolism and nutrition disorders     
Hypocalcemia  1  0/43 (0.00%)  0 1/42 (2.38%)  1
Hypokalemia  1  0/43 (0.00%)  0 1/42 (2.38%)  2
Hyponatremia  1  0/43 (0.00%)  0 1/42 (2.38%)  1
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  0/43 (0.00%)  0 1/42 (2.38%)  5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  0/43 (0.00%)  0 1/42 (2.38%)  1
Nervous system disorders     
Dizziness  1  0/43 (0.00%)  0 1/42 (2.38%)  1
Headache  1  1/43 (2.33%)  1 0/42 (0.00%)  0
Peripheral sensory neuropathy  1  0/43 (0.00%)  0 1/42 (2.38%)  5
Syncope  1  1/43 (2.33%)  1 0/42 (0.00%)  0
Renal and urinary disorders     
Cystitis noninfective  1  1/43 (2.33%)  1 0/42 (0.00%)  0
Hematuria  1  1/43 (2.33%)  2 0/42 (0.00%)  0
Urinary frequency  1  1/43 (2.33%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysesthesia syndrome  1  0/43 (0.00%)  0 1/42 (2.38%)  1
Rash acneiform  1  0/43 (0.00%)  0 1/42 (2.38%)  1
Rash maculo-papular  1  0/43 (0.00%)  0 2/42 (4.76%)  2
Urticaria  1  0/43 (0.00%)  0 1/42 (2.38%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert C. Miller, M.D., M.S.
Organization: Mayo Clinic
EMail: miller.robert@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01198145    
Other Study ID Numbers: NCCTG-N08C9
NCI-2011-02602 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000684240 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: September 8, 2010
First Posted: September 9, 2010
Results First Submitted: November 28, 2016
Results First Posted: April 4, 2017
Last Update Posted: December 3, 2019