Abstract | BACKGROUND: METHODS: A randomized, double-blinded, placebo-controlled trial was designed to determine the efficacy of long-acting octreotide acetate (LAO) in preventing the onset of acute diarrhea in patients undergoing chemoradiation therapy for rectal or anal cancer. Between 4 and 7 days before the start of radiation therapy, patients received a 30-mg dose of LAO (109 patients) or placebo (106 patients) via intramuscular injection. A second dose was given on day 22 (+/-3 days) of radiation treatment. A total of 215 patients were included in the final analysis. The primary endpoint was the incidence of grade 2-4 acute diarrhea; secondary endpoints included treatment compliance, medical resource utilization, patient-reported bowel function, and quality of life (QoL). Statistical tests were one- or two-sided, as specified. RESULTS: After a median follow-up time of 9.64 months, incidence rates of grades 2-4 acute diarrhea were similar in both groups (49% placebo vs 44% LAO; P = .21). No statistically significant treatment differences in chemotherapy or radiation delivery, medical resource utilization, patient-reported bowel function, or QoL were observed. CONCLUSION: In this study, the prophylactic use of LAO did not prevent the incidence or reduce the severity of diarrhea and had no notable impact on patient-reported bowel function or QoL.
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Authors | Babu Zachariah, Clement K Gwede, Jennifer James, Jaffer Ajani, Lisa J Chin, David Donath, Seth A Rosenthal, Brent L Kane, Marvin Rotman, Lawrence Berk, Lisa A Kachnic |
Journal | Journal of the National Cancer Institute
(J Natl Cancer Inst)
Vol. 102
Issue 8
Pg. 547-56
(Apr 21 2010)
ISSN: 1460-2105 [Electronic] United States |
PMID | 20339140
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
- Antidiarrheals
- Antineoplastic Agents
- Octreotide
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Topics |
- Acute Disease
- Adult
- Aged
- Antidiarrheals
(administration & dosage, therapeutic use)
- Antineoplastic Agents
(adverse effects)
- Anus Neoplasms
(drug therapy, radiotherapy)
- Chemotherapy, Adjuvant
(adverse effects)
- Diarrhea
(chemically induced, etiology, prevention & control)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Health Resources
(statistics & numerical data)
- Humans
- Incidence
- Injections, Intramuscular
- Male
- Middle Aged
- Octreotide
(administration & dosage, therapeutic use)
- Quality of Life
- Radiotherapy, Adjuvant
(adverse effects)
- Rectal Neoplasms
(drug therapy, physiopathology, radiotherapy)
- Severity of Illness Index
- Treatment Failure
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