Limited areas of cancer in the lower abdomen and pelvis Cancer
Conditions
Interventions
Patients will receive intramuscular HBB 20 mg (into upper outer quadrant of gluteal muscle) on fractions 1, 3 and 5 of a five-fraction SABR treatment (or fractions 1 and 3 of a three-fraction regimen)
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Capacity to give written, informed consent 3. WHO performance status 0-2 4. Histologically or radiologically confirmed lymph node or bone oligometastatic disease in the abdomen or pelvis limited to 6 months 7. No co-morbid conditions likely to impact on the advisability of SABR (e.g. previous inflammatory bowel disease, previous abdominal or pelvic surgery, significant bladder instability or urinary incontinence, clinically significant renal or hepatic impairment) 8. No comorbidities likely to impact on safety of administration of HBB (for example severe cardiac disease, recent cardiac event, cardiac tachyarrhythmias, angle closure glaucoma, myasthenia gravis, pyloric stenosis, porphyria, severe ulcerative colitis, paralytic ileus, obstructive uropathy or allergy to HBB) 9. No bilateral prosthetic hips- this would prevent use of volumetric modulated arc therapy (VMAT) solution for SABR 10. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial
Exclusion criteria
Exclusion criteria: No comorbidities likely to impact on safety of administration of HBB (for example severe cardiac disease, recent cardiac event, cardiac tachyarrythmias, angle closure glaucoma, myasthenia gravis, pyloric stenosis, porphyria, severe ulcerative colitis, paralytic ileus, obstructive uropathy or allergy to hyoscine butylbromide)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cone beam CT image quality when HBB administered, determined by proportion of images with improved Likert-type scale results at end of SABR treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Feasibility of administration of intramuscular HBB within a clinical abdomino-pelvic SABR workflow, measured using questionnaire at time of final SABR fraction 2. Patient and radiotherapy department staff acceptability of intramuscular HBB injection, assessed using questionnaire at time of final SABR fraction | — |
Countries
United Kingdom
Outcome results
None listed