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Octreotide acetate in prevention of chemoradiation-induced diarrhea in anorectal cancer: randomized RTOG trial 0315

Plain-language guide to PMID 20339140 (2010): double-blind randomized controlled trial study of Octreotide in 109 patients.

Key Facts

PMID
20339140
Journal
Journal of the National Cancer Institute
Year
2010
Study type
Randomized Controlled Trial
Authors
Zachariah B et al. (11 authors)
DOI
10.1093/jnci/djq063
Registered trial
NCT00075868

What This Study Did, in Plain Language

What Was Tested

The paper reports a study of Octreotide, published as a randomized controlled trial.

In anorectal cancer patients, an acute side effect of chemoradiotherapy is gastrointestinal toxicity, which often impedes treatment delivery.

Based on previous trials, octreotide acetate is widely recommended for the control of chemotherapy-induced diarrhea.

Who Took Part

The study group was 109 patients.

PubMed indexes the participants as adults, middle-aged adults and older adults, both men and women.

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).

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

The patients were allocated by chance, so the Octreotide group and the comparison group should start out alike.

Neither the patients nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Octreotide could be set against what happens without it.

Statistical tests were one- or two-sided, as specified.

What Was Measured

In anorectal cancer patients, an acute side effect of chemoradiotherapy is gastrointestinal toxicity, which often impedes treatment delivery.

The subject headings attached to it are Acute Disease, Antidiarrheals, Antineoplastic Agents, Anus Neoplasms, Chemotherapy, Adjuvant, Diarrhea and Health Resources.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Octreotide in 109 patients.

The abstract goes on to report its results in about 3 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2010 (Journal of the National Cancer Institute), a journal based in United States.

More context: the Octreotide compound page.

Our Notes on the Compound

Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.