DIARRHOEA AFTER RADIOTHERAPY

Study shows ENTEROSGEL is an effective supportive treatment for patients suffering with diarrhoea after radiotherapy.

Two major UK cancer conferences in November 2016, NCRI in Liverpool and UKONS in Brighton have chosen a new study with ENTEROSGEL to be published and presented with a poster.

Preliminary results from a new study [1] indicate that ENTEROSGEL can be recommended as a supportive treatment during pelvic radiation in patients with uterine and cervical cancer, as it effectively reduces gastrointestinal problems and weight loss and is gentle on the digestive system.

Approximately 13,000 patients undergo pelvic radiotherapy annually in the UK [2]. Radiation-induced gastrointestinal complications are common, affecting 6,000 individuals annually in the UK, and can have a negative impact on quality of life [3]. Adverse reactions include frequent stools and urination, dysuria, tenesmus, abdominal pain and blood count changes.

Dietary manipulation, sufficient fluid intake, and medications are recommended to help reduce side effects, but there is a need for new supportive treatments. Researchers at University Hospital Centre Zagreb have conducted a clinical study to provide a safe and effective supportive treatment option for the management of gastrointestinal symptoms associated with radiotherapy.

The aim of their research study was to investigate whether the intestinal adsorbent, Enterosgel®, could help reduce adverse reactions associated with pelvic radiotherapy in patients with uterine or cervical cancer. The specific objectives were to investigate the impact of Enterosgel® on Eastern Cooperative Oncology Group Performance (ECOG) [4], change in body weight, diarrhoea, nausea, blood leukocytes, thrombocytes, and erythrocytes, and electrolytes (potassium and sodium).

Enterosgel® is a polymethyl siloxane-based hydrogel, obtained through polycondensation of methyl silicic acid. It has selective sorptive activity towards medium and high molecular weight substances in the gut, including middle-molecular weight toxic metabolites. In the UK, Enterosgel® is certified as a medical device class IIA with an indication for diarrhoea. It has a good safety profile and has been suggested in some studies to reduce vomiting and other side effects of polychemotherapy [5].

90 female patients with a diagnosis of cervical or uterine cancer were recruited at the Division of gynaecological oncology, Women’s health clinic, Zagreb, Croatia. All patients were receiving pelvic radiotherapy, with or without concomitant cisplatin therapy.

This was a randomised, controlled, 5-week medical device study (Study title: “The role of Enterosgel in prevention of gastrointestinal adverse reactions of percutaneous radiation”). Patients were randomised into two groups. The experimental group received 45g of Enterosgel per day (one tablespoon three times a day). The control group did not receive Enterosgel or any other supportive treatment. An unpaired t-test was used for comparing means of two individual variables between the groups;

The following outcomes were compared between the Experimental and the Control group at week 5: ECOG, change in body weight from baseline, number of diarrhoeal stools since baseline, number of days with nausea since baseline, blood leukocytes, thrombocytes, and erythrocytes, and electrolytes (potassium and sodium).

All 90 patients completed the study and were included in the analyses. Over the 5-week treatment period, patients in the Enterosgel® group reported significantly fewer diarrhoeal stools than patients in the control group. Patients in the Enterosgel® group also reported fewer days with nausea. Weight loss from baseline was significantly lower in the Enterosgel® group.

There was no evidence for significant differences between the groups in ECOG, leukocyte count, thrombocyte count, erythrocyte count, potassium level or sodium level. No adverse reactions associated with the use of Enterosgel® were reported.

The researchers’ findings suggest that Enterosgel® could be used as an effective supportive treatment to prevent or reduce diarrhoea, nausea and weight loss associated with pelvic radiotherapy. This study provides further evidence that Enterosgel® is safe and well-tolerated. Further research will be required to confirm these preliminary findings.

References

[1] Enterosorption as a supportive treatment during external radiotherapy in patients with uterine and cervical cancer – Višnja Matković1, Kristina Katić1, Ante Ćorušić1, Robert Likić2

1Department of gynaecological oncology, Clinic for Obstetrics and Gynecology, University Hospital Centre Zagreb, Zagreb
2 Department of Clinical Pharmacology, University Hospital Centre Zagreb, Zagreb

[2] Gami B, Harrington K, Blake P, Dearnaley D, Tait D, Davies J, Norman AR, Andreyev HJ. (2003). Aliment Pharmacol Ther. 18:987–994.

[3] Andreyev J. (2005). Gut 54:1051–1054.

[4] Oken M, Creech R, Tormey D, Horton J, Davis TE, McFadden ET, Carbone PP.(1982). Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 5:649-655.

[5] Nikolaev VG, Mikhalovsky S, Khajibaev A. (2011). Enterosgel: A Novel Organosilicon Enterosorbent with a Wide Range of Medical Applications. Biodefence: Advanced Materials and Methods for Health Protection. Springer Netherlands. pp 199-211.

Download study poster here

Read abstract at NCRI cancer conference in Liverpool, UK 6-9 November 2016

http://www.ukons.org

DIARRHOEA AFTER RADIOTHERAPY | For supportive treatment of diarrhoea, allergies and IBS-D