Management of gastrointestinal complaints in differentiated thyroid cancer patients treated with ¹³¹I

Summary

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: Post- radioiodine 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 hyper- emesis 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.

Zusammenfassung

Ziel: Vergleich der Sicherheit und Wirksamkeit von Pantoprazol, Metoclopramid, Ondansetron versus Placebo zur Kontrolle gastrointestinaler (GI) Beschwerden bei Patienten mit Schilddrüsenkarzinom, die mit ¹³¹I behandelt werden. Design: vierarmige, einfach-blinde, randomisierte, kontrollierte klinische Parallelgruppen-Studie. Setting: Universitätsklinik, Registrierung: Datenbank zur Registrierung klinischer Studien IRCT2013061713705N1. Patienten: 85 Patienten mit differenziertem Schilddrüsenkarzinom, behandelt mit ¹³¹I. Hauptzielparameter: Übelkeit und Erbrechen innerhalb von drei Tagen nach Radiojodtherapie (primärer Endpunkt); Auftreten unerwünschter Ereignisse. Ergebnisse: Die Patien- tencharakteristika in den Studiengruppen waren vergleichbar. Zwischen den Gruppen gab es keine statistisch signifikanten Unterschiede bei den Studienvariablen Alter, Geschlecht, verabreichte Dosis, anamnestisch bekannte GI-Beschwerden sowie, bei Frauen, Hyperemesis gravidarum in der Anamnese (p > 0,05). Die Ergebnisse zeigten nur für On- dansetron einen therapeutischen Vorteil gegenüber Placebo (p < 0,05) bei der Kontrolle der Übelkeit, jedoch wirkte es nicht präventiv gegen Erbrechen (p > 0,05). Die anderen beiden Präparate, Pantoprazol und Metoclopra- mid, unterdrückten weder Übelkeit (p > 0,05) noch Erbrechen (p > 0,05). Schlussfolgerungen: Mit dieser Studie könnte Ondansetron in therapeutischer Dosierung ein effektives Pro- phylaktikum gegen GI-Beschwerden bei Patienten mit differenziertem Schilddrüsenkarzinom nach Radioiodtherapie darstellen; allerdings sollten diese vorläufigen Ergebnisse in größeren Studien validiert werden.

Keywords

Differentiated thyroid cancer - gastrointestinal complaint - pantoprazole - metoclopramide - ondansetron

Schlüsselwörter

Differenziertes Schilddrüsenkarzinom - gastro intestinale Beschwerden - Pantoprazol - Metoclopramid - Ondansetron

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