Page last updated: 2024-11-04

sulfasalazine and Injuries, Radiation

sulfasalazine has been researched along with Injuries, Radiation in 9 studies

Sulfasalazine: A drug that is used in the management of inflammatory bowel diseases. Its activity is generally considered to lie in its metabolic breakdown product, 5-aminosalicylic acid (see MESALAMINE) released in the colon. (From Martindale, The Extra Pharmacopoeia, 30th ed, p907)
sulfasalazine : An azobenzene consisting of diphenyldiazene having a carboxy substituent at the 4-position, a hydroxy substituent at the 3-position and a 2-pyridylaminosulphonyl substituent at the 4'-position.

Research Excerpts

ExcerptRelevanceReference
" At the time of a planned interim toxicity analysis, more patients with grade ≥3 diarrhea received sulfasalazine than received placebo (29% vs 11%, P=."9.22N08C9 (Alliance): A Phase 3 Randomized Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy. ( Bearden, JD; Iott, MJ; Liem, B; Liu, H; Loprinzi, CL; Martenson, JA; Miller, RC; Mowat, RB; Petereit, DG; Sapiente, R; Seeger, GR; Sloan, JA, 2016)
" At the time of a planned interim toxicity analysis, more patients with grade ≥3 diarrhea received sulfasalazine than received placebo (29% vs 11%, P=."5.22N08C9 (Alliance): A Phase 3 Randomized Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy. ( Bearden, JD; Iott, MJ; Liem, B; Liu, H; Loprinzi, CL; Martenson, JA; Miller, RC; Mowat, RB; Petereit, DG; Sapiente, R; Seeger, GR; Sloan, JA, 2016)
"Radiation enteritis is a severe problem in patients receiving irradiation of the abdomen or pelvis in the course of cancer treatment."2.44Medical prevention and treatment of acute and chronic radiation induced enteritis--is there any proven therapy? a short review. ( Böcker, U; Singer, MV; Wenz, F; Zimmerer, T, 2008)

Research

Studies (9)

TimeframeStudies, this research(%)All Research%
pre-19905 (55.56)18.7374
1990's1 (11.11)18.2507
2000's2 (22.22)29.6817
2010's1 (11.11)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Miller, RC1
Petereit, DG1
Sloan, JA1
Liu, H1
Martenson, JA1
Bearden, JD1
Sapiente, R1
Seeger, GR1
Mowat, RB1
Liem, B1
Iott, MJ1
Loprinzi, CL1
Zimmerer, T1
Böcker, U1
Wenz, F1
Singer, MV1
Lenner, V1
Yoshimura, K1
Hirata, I1
Maemura, K1
Sugi, K1
Tahara, T1
Goldstein, F1
Khoury, J1
Thornton, JJ1
Chevrel, B1
Kochhar, R1
Patel, F1
Dhar, A1
Sharma, SC1
Ayyagari, S1
Aggarwal, R1
Goenka, MK1
Gupta, BD1
Mehta, SK1
Jacobs, H1
Rindt, W1
Schmid, N1
Rauch, K1
Weiland, H1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy[NCT01198145]Phase 387 participants (Actual)Interventional2011-04-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications.

The number of patients reporting the use of anti-diarrheal medications divided by the number of patients evaluated for this endpoint. (NCT01198145)
Timeframe: Up to 24 months post radiotherapy

Interventionpercentage of participants (Number)
Arm I: Sulfasalazine48.7
Arm II: Placebo28.6

"Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire"

"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?" (NCT01198145)
Timeframe: Up to 6 weeks post radiation therapy

,
Interventionpercentage of participants (Number)
During RT : Q2During RT : Q3During RT : Q4During RT : Q5During RT : Q6During RT : Q7During RT : Q8During RT : Q9During RT : Q10After RT : Q2After RT : Q3After RT : Q4After RT : Q5After RT : Q6After RT : Q7After RT : Q8After RT : Q9After RT : Q10
Arm I: Sulfasalazine191133726114447392455183737703450
Arm II: Placebo1010330232043177272256124637613429

Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT

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. (NCT01198145)
Timeframe: During radiation therapy and up to 6 weeks post radiation therapy

,
Interventiongrade*week (Mean)
During RTAfter RT
Arm I: Sulfasalazine4.01.2
Arm II: Placebo3.31.3

Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0

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. (NCT01198145)
Timeframe: During radiation therapy and up to 6 weeks post radiation therapy

,
InterventionAverage Grade of Event (Mean)
Tenesmus during RTTenesmus after RTAbdominal pain during RTAbdominal pain after RTConstipation during RTConstipation after RTDiarrhea during RTDiarrhea after RTRectal bleeding during RTRectal bleeding after RT
Arm I: Sulfasalazine0.20.10.30.20.20.10.80.30.20.1
Arm II: Placebo0.10.10.20.20.20.10.60.30.20.1

Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT)

"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." (NCT01198145)
Timeframe: During radiation therapy and up to 6 weeks post radiation therapy

,
InterventionParticipants (Count of Participants)
Grade 0Grade 1Grade 2Grade 3Grade 4
Arm I: Sulfasalazine10138101
Arm II: Placebo10151340

Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue

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. (NCT01198145)
Timeframe: Up to 6 weeks post radiotherapy

,
Interventionpercentage of participants (Number)
During RTAfter RT
Arm I: Sulfasalazine17.926.9
Arm II: Placebo7.527.6

Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT

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. (NCT01198145)
Timeframe: During radiation therapy and up to 6 weeks post radiation therapy

,
Interventionpercentage of participants (Number)
Tenesmus during RTTenesmus after RTAbdominal pain during RTAbdominal pain after RTConstipation during RTConstipation after RTDiarrhea during RTDiarrhea after RTRectal bleeding during RTRectal bleeding after RT
Arm I: Sulfasalazine35.711.947.619.138.114.376.233.338.111.9
Arm II: Placebo28.619.138.111.935.716.773.835.747.64.8

Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT

"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." (NCT01198145)
Timeframe: During radiation therapy and up to 6 weeks post radiation therapy

InterventionParticipants (Count of Participants)
Tenesmus during RT72333267Tenesmus during RT72333269Tenesmus after RT72333267Tenesmus after RT72333269Abdominal pain during RT72333267Abdominal pain during RT72333269Abdominal pain after RT72333269Abdominal pain after RT72333267Constipation during RT72333267Constipation during RT72333269Constipation after RT72333269Constipation after RT72333267Diarrhea during RT72333267Diarrhea during RT72333269Diarrhea after RT72333269Diarrhea after RT72333267Rectal bleeding during RT72333267Rectal bleeding during RT72333269Rectal bleeding after RT72333267Rectal bleeding after RT72333269
Grade 0Grade 1Grade 4Grade 2Grade 3
Arm I: Sulfasalazine27
Arm II: Placebo30
Arm II: Placebo9
Arm I: Sulfasalazine7
Arm I: Sulfasalazine18
Arm II: Placebo21
Arm I: Sulfasalazine5
Arm II: Placebo7
Arm II: Placebo1
Arm I: Sulfasalazine0
Arm I: Sulfasalazine22
Arm II: Placebo26
Arm I: Sulfasalazine14
Arm II: Placebo12
Arm II: Placebo4
Arm I: Sulfasalazine3
Arm II: Placebo0
Arm I: Sulfasalazine17
Arm II: Placebo24
Arm I: Sulfasalazine8
Arm II: Placebo2
Arm II: Placebo3
Arm I: Sulfasalazine12
Arm I: Sulfasalazine4
Arm I: Sulfasalazine19
Arm II: Placebo22
Arm I: Sulfasalazine6
Arm II: Placebo6
Arm I: Sulfasalazine10
Arm II: Placebo11
Arm I: Sulfasalazine13
Arm II: Placebo14
Arm I: Sulfasalazine9
Arm II: Placebo13
Arm I: Sulfasalazine1
Arm I: Sulfasalazine11
Arm II: Placebo10
Arm I: Sulfasalazine2
Arm I: Sulfasalazine26
Arm I: Sulfasalazine16
Arm II: Placebo20
Arm I: Sulfasalazine20
Arm II: Placebo27

Reviews

1 review available for sulfasalazine and Injuries, Radiation

ArticleYear
Medical prevention and treatment of acute and chronic radiation induced enteritis--is there any proven therapy? a short review.
    Zeitschrift fur Gastroenterologie, 2008, Volume: 46, Issue:5

    Topics: Abdominal Neoplasms; Acute Disease; Chronic Disease; Combined Modality Therapy; Controlled Clinical

2008

Trials

2 trials available for sulfasalazine and Injuries, Radiation

ArticleYear
N08C9 (Alliance): A Phase 3 Randomized Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy.
    International journal of radiation oncology, biology, physics, 2016, 07-15, Volume: 95, Issue:4

    Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Diarrhea; Double-Blind Method; Enteritis; Female; Hum

2016
Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate.
    Digestive diseases and sciences, 1991, Volume: 36, Issue:1

    Topics: Administration, Oral; Administration, Rectal; Adult; Aged; Colonoscopy; Double-Blind Method; Drug Th

1991

Other Studies

6 other studies available for sulfasalazine and Injuries, Radiation

ArticleYear
[Treatment of early and late intestinal radiation injuries].
    Deutsche medizinische Wochenschrift (1946), 1980, Jun-27, Volume: 105, Issue:26

    Topics: Humans; Intestinal Obstruction; Intestines; Postoperative Complications; Radiation Injuries; Sulfasa

1980
Radiation enteritis: a rare complication of the transverse colon in uterine cancer.
    Internal medicine (Tokyo, Japan), 2000, Volume: 39, Issue:12

    Topics: Abdominal Pain; Anastomosis, Surgical; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative;

2000
Treatment of chronic radiation enteritis and colitis with salicylazosulfapyridine and systemic corticosteroids. A pilot study.
    The American journal of gastroenterology, 1976, Volume: 65, Issue:3

    Topics: Aged; Colitis; Colon; Enteritis; Humans; Ileum; Intestine, Large; Intestine, Small; Middle Aged; Pil

1976
[Inflammatory diseases of the colon and salazopyrine. Value of long term treatment].
    Medecine & chirurgie digestives, 1976, Volume: 5, Issue:5

    Topics: Chemical Phenomena; Chemistry; Colitis; Colonic Diseases; Crohn Disease; Female; Gastrointestinal He

1976
[Treatment of radiation proctitis].
    Geburtshilfe und Frauenheilkunde, 1971, Volume: 31, Issue:11

    Topics: Administration, Oral; Adult; Aged; Fecal Incontinence; Female; Genital Neoplasms, Female; Humans; Me

1971
[Therapy of radiogenic colitis with salicylazosulfapyridine (azulfidine)].
    Strahlentherapie, 1972, Volume: 143, Issue:6

    Topics: Cobalt Isotopes; Colitis; Diarrhea; Female; Humans; Radiation Injuries; Radioisotope Teletherapy; Su

1972