McGough, C., Wedlake, L., Baldwin, C., Hackett, C., Norman, A.R., Blake, P., … Andreyev, H.J. (2008). Clinical trial: Normal diet vs. partial replacement with oral E028 formula for the prevention of gastrointestinal toxicity in cancer patients undergoing pelvic radiotherapy. Alimentary Pharmacology & Therapeutics, 27(11), 1132–1139.
To determine whether replacing a third of the normal diet with an elemental formula (E028) during the first three weeks of pelvic radiotherapy is feasible and effective in decreasing acute gastrointestinal (GI) toxicity
Patients with a gynecologic, urologic, or lower GI malignancy who were scheduled to receive radical or adjuvant radiotherapy to the pelvis were randomized to receive either an elemental diet, which involved replacing one normal meal per day with the elemental formula E028 Extra, or no intervention for the first three weeks of treatment.
The study was conducted in an oupatient care setting in the United Kingdom.
Patients were undergoing the active treatment phase of care.
This was a prospective, randomized-controlled trial.
The Inflammatory Bowel Disease Questionnaire – Bowel specific sub-set (IBDQ-B), Vaizey Incontinence Questionnaire (VIQ), and Radiation Therapy Oncology Group (RTOG) tool were used.
Patients in the intervention group exhibited poor compliance, ingesting only 65% of the proposed oral elemental formula. The intervention group did not experience a reduction in bowel symptoms or fecal calprotectin compared to the control group.
This study did not show a benefit to ingesting elemental formula. Orally ingested elemental formulae are known to be unpalatable, and the intervention group had poor compliance with consuming the proposed amount of formula.