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Elemental Nutrition in Gastrointestinal symptom management during pelvic radiotherapy (enigma)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN08312234
Enrollment
102
Registered
2005-09-30
Start date
2004-11-25
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic cancers Cancer Malignant neoplasm of other or ill-defined sites

Interventions

Randomised test intervention versus no intervention controls, non-blinded Phase III

Sponsors

Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 102 RMH patients, with a diagnosis of gynaecological or urological malignancy. Will be undergoing a course of radical or adjuvant pelvic radiotherapy to a curative dose (including patients undergoing concomitant chemotherapy).

Exclusion criteria

Exclusion criteria: 1. Patients with condition precluding oral nutrition 2. Patients undergoing conformal radiotherapy or intra-cavity brachytherapy 3. Patients with clotting disorders

Design outcomes

Primary

MeasureTime frame
To assess bowel toxicity using IBDQ and to assess whether there are differences in the score in patients in their intervention arm and the control.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026