Demiral, S., Beyzadeoglu, M., Sager, O., Dincoglan, F., Uysal, B., Gamsiz, H., . . . Turker, T. (2015). Evaluation of transforming growth factor-β2 for radiation-induced diarrhea after pelvic radiotherapy. Tumori, 101, 474–477. 

To evaluate the use of transforming growth factor (TGF)-β2-enriched formula for amelioration of radiation-induced diarrhea for patients undergoing pelvic RT

There were three groups. Patients in group one were supported with TGF-β2-enriched formula from the first day of RT until at least one month after treatment completion. They used diphenoxylate-atropine tablets after the onset of diarrhea. Patients in group two started on diphenoxylate-atropine tablets and TGF-β2-enriched formula typically in the second week of  RT. They used TGF-β2-enriched formula for a period of at least one month after treatment completion. Patients in the third group received diphenoxylate-atropine tablets and feeding formulas (other TGF-β2-enriched formula) after onset of diarrhea, typically in the second week of  RT. They used TGF-β2-enriched formula for a period of at least one month after treatment completion. Diarrhea was measured weekly.

• N = 86  
• AGE RANGE: 35–77 years
• NUMBER OF MALES: 67  
• NUMBER OF FEMALES: 19
• KEY DISEASE CHARACTERISTICS: Malnourished patients undergoing RT for pelvic cancers

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Gulhane Military Medical Academy, Ankara, Turkey

• PHASE OF CARE: Active antitumor treatment

• Retrospective analysis

• Common Terminology Criteria for Adverse Events (CTCAE) version 4

Patients receiving nutritional supplementation with TGR-β2-enriched formula (group one and two) experienced a lower median number of diarrhea episodes (p < 0.003) at all time points, and grade 2/3 diarrhea was also lower in these groups. Onset of diarrhea was typically the second week in all the groups. There was no statistical significance is diagnosis in the three groups. The number of patients with grade 2 diarrhea decreased after the second week of RT in groups one and two, and these patients did not experience grade 2 diarrhea one month after RT. However, the number of grade 2 diarrhea increased in group three after the second week of RT.

Patients receiving nutritional supplementation with TGF-β2-enriched formula had a decreased number of grade 2 and grade 3 diarrhea episodes compared to those receiving other nutritional supplements.

• Small sample (less than 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)

Patients receiving nutritional supplementation with TGR-β2-enriched formula with diphenoxylate-atropine supplementation while receiving RT may reduce the incidence of diarrhea, but further studies are needed.