Management of gastrointestinal complaints in differentiated thyroid cancer patients treated with (131)I: comparison of the efficacy of pantoprazole, metoclopramide, and ondansetron - a randomized clinical trial.

OBJECTIVE

To compare safety and efficacy of pantoprazol , metoclopramide, ondansetron, as compared to placebo, in controlling gastrointestinal (GI) complaints of thyroid cancer patients treated with I-131these patients.

DESIGN

Four-armed, parallel group, single blind, randomized controlled clinical trial, setting: A university hospital, registration: database for clinical trials IRCT2013061713705N1.

PATIENTS: 85 patients with differentiated thyroid cancer who received 131I.

MAIN OUTCOME MEASURES: Postradioiodine nausea and vomiting within three days of therapy (primary endpoint); occurrence of adverse reaction.

RESULTS

The patients' characteristics were similar within the study groups. Among the study variables, age, sex, administered dosage, history of previous GI complaints, and history of hyperemesis gravidarum in female patients were not statistically different among the groups (p > 0.05). The results revealed that only ondansetron shows a therapeutic benefit over the placebo in controlling nausea (p < 0.05); however, it does not prevent vomiting (p > 0.05). The other two drugs, pantoprazole and metoclopramide, did not control nausea (p > 0.05) or vomiting (p > 0.05).

CONCLUSIONS

This study may demonstrate that the therapeutic dose of ondansetron could be an effective prophylactic agent in controlling GI complaints in differential thyroid carcinoma (DTC) patients following RAI therapy; however, these preliminary findings should be validated in larger studies.