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.
Excerpt | Relevance | Reference |
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" At the time of a planned interim toxicity analysis, more patients with grade ≥3 diarrhea received sulfasalazine than received placebo (29% vs 11%, P=." | 9.22 | N08C9 (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=." | 5.22 | N08C9 (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." | 2.44 | Medical 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) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 5 (55.56) | 18.7374 |
1990's | 1 (11.11) | 18.2507 |
2000's | 2 (22.22) | 29.6817 |
2010's | 1 (11.11) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Miller, RC | 1 |
Petereit, DG | 1 |
Sloan, JA | 1 |
Liu, H | 1 |
Martenson, JA | 1 |
Bearden, JD | 1 |
Sapiente, R | 1 |
Seeger, GR | 1 |
Mowat, RB | 1 |
Liem, B | 1 |
Iott, MJ | 1 |
Loprinzi, CL | 1 |
Zimmerer, T | 1 |
Böcker, U | 1 |
Wenz, F | 1 |
Singer, MV | 1 |
Lenner, V | 1 |
Yoshimura, K | 1 |
Hirata, I | 1 |
Maemura, K | 1 |
Sugi, K | 1 |
Tahara, T | 1 |
Goldstein, F | 1 |
Khoury, J | 1 |
Thornton, JJ | 1 |
Chevrel, B | 1 |
Kochhar, R | 1 |
Patel, F | 1 |
Dhar, A | 1 |
Sharma, SC | 1 |
Ayyagari, S | 1 |
Aggarwal, R | 1 |
Goenka, MK | 1 |
Gupta, BD | 1 |
Mehta, SK | 1 |
Jacobs, H | 1 |
Rindt, W | 1 |
Schmid, N | 1 |
Rauch, K | 1 |
Weiland, H | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy[NCT01198145] | Phase 3 | 87 participants (Actual) | Interventional | 2011-04-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
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
Intervention | percentage of participants (Number) |
---|---|
Arm I: Sulfasalazine | 48.7 |
Arm II: Placebo | 28.6 |
"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
Intervention | percentage of participants (Number) | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
During RT : Q2 | During RT : Q3 | During RT : Q4 | During RT : Q5 | During RT : Q6 | During RT : Q7 | During RT : Q8 | During RT : Q9 | During RT : Q10 | After RT : Q2 | After RT : Q3 | After RT : Q4 | After RT : Q5 | After RT : Q6 | After RT : Q7 | After RT : Q8 | After RT : Q9 | After RT : Q10 | |
Arm I: Sulfasalazine | 19 | 11 | 33 | 7 | 26 | 11 | 44 | 4 | 7 | 39 | 24 | 55 | 18 | 37 | 37 | 70 | 34 | 50 |
Arm II: Placebo | 10 | 10 | 33 | 0 | 23 | 20 | 43 | 17 | 7 | 27 | 22 | 56 | 12 | 46 | 37 | 61 | 34 | 29 |
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
Intervention | grade*week (Mean) | |
---|---|---|
During RT | After RT | |
Arm I: Sulfasalazine | 4.0 | 1.2 |
Arm II: Placebo | 3.3 | 1.3 |
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
Intervention | Average Grade of Event (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Tenesmus during RT | Tenesmus after RT | Abdominal pain during RT | Abdominal pain after RT | Constipation during RT | Constipation after RT | Diarrhea during RT | Diarrhea after RT | Rectal bleeding during RT | Rectal bleeding after RT | |
Arm I: Sulfasalazine | 0.2 | 0.1 | 0.3 | 0.2 | 0.2 | 0.1 | 0.8 | 0.3 | 0.2 | 0.1 |
Arm II: Placebo | 0.1 | 0.1 | 0.2 | 0.2 | 0.2 | 0.1 | 0.6 | 0.3 | 0.2 | 0.1 |
"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
Intervention | Participants (Count of Participants) | ||||
---|---|---|---|---|---|
Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
Arm I: Sulfasalazine | 10 | 13 | 8 | 10 | 1 |
Arm II: Placebo | 10 | 15 | 13 | 4 | 0 |
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
Intervention | percentage of participants (Number) | |
---|---|---|
During RT | After RT | |
Arm I: Sulfasalazine | 17.9 | 26.9 |
Arm II: Placebo | 7.5 | 27.6 |
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
Intervention | percentage of participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Tenesmus during RT | Tenesmus after RT | Abdominal pain during RT | Abdominal pain after RT | Constipation during RT | Constipation after RT | Diarrhea during RT | Diarrhea after RT | Rectal bleeding during RT | Rectal bleeding after RT | |
Arm I: Sulfasalazine | 35.7 | 11.9 | 47.6 | 19.1 | 38.1 | 14.3 | 76.2 | 33.3 | 38.1 | 11.9 |
Arm II: Placebo | 28.6 | 19.1 | 38.1 | 11.9 | 35.7 | 16.7 | 73.8 | 35.7 | 47.6 | 4.8 |
"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
Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Tenesmus during RT72333267 | Tenesmus during RT72333269 | Tenesmus after RT72333267 | Tenesmus after RT72333269 | Abdominal pain during RT72333267 | Abdominal pain during RT72333269 | Abdominal pain after RT72333269 | Abdominal pain after RT72333267 | Constipation during RT72333267 | Constipation during RT72333269 | Constipation after RT72333269 | Constipation after RT72333267 | Diarrhea during RT72333267 | Diarrhea during RT72333269 | Diarrhea after RT72333269 | Diarrhea after RT72333267 | Rectal bleeding during RT72333267 | Rectal bleeding during RT72333269 | Rectal bleeding after RT72333267 | Rectal bleeding after RT72333269 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Grade 0 | Grade 1 | Grade 4 | Grade 2 | Grade 3 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 27 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 30 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 22 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 26 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 14 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 24 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 19 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 22 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 13 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 14 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 13 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 26 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 16 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm I: Sulfasalazine | 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm II: Placebo | 27 |
1 review available for sulfasalazine and Injuries, Radiation
Article | Year |
---|---|
Medical prevention and treatment of acute and chronic radiation induced enteritis--is there any proven therapy? a short review.
Topics: Abdominal Neoplasms; Acute Disease; Chronic Disease; Combined Modality Therapy; Controlled Clinical | 2008 |
2 trials available for sulfasalazine and Injuries, Radiation
Article | Year |
---|---|
N08C9 (Alliance): A Phase 3 Randomized Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy.
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.
Topics: Administration, Oral; Administration, Rectal; Adult; Aged; Colonoscopy; Double-Blind Method; Drug Th | 1991 |
6 other studies available for sulfasalazine and Injuries, Radiation
Article | Year |
---|---|
[Treatment of early and late intestinal radiation injuries].
Topics: Humans; Intestinal Obstruction; Intestines; Postoperative Complications; Radiation Injuries; Sulfasa | 1980 |
Radiation enteritis: a rare complication of the transverse colon in uterine cancer.
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.
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].
Topics: Chemical Phenomena; Chemistry; Colitis; Colonic Diseases; Crohn Disease; Female; Gastrointestinal He | 1976 |
[Treatment of radiation proctitis].
Topics: Administration, Oral; Adult; Aged; Fecal Incontinence; Female; Genital Neoplasms, Female; Humans; Me | 1971 |
[Therapy of radiogenic colitis with salicylazosulfapyridine (azulfidine)].
Topics: Cobalt Isotopes; Colitis; Diarrhea; Female; Humans; Radiation Injuries; Radioisotope Teletherapy; Su | 1972 |