Barber, C., Powell, R., Ellis, A., & Hewett, J. (2007). Comparing pain control and ability to eat and drink with standard therapy vs. Gelclair: A preliminary, double centre, randomised controlled trial on patients with radiotherapy-induced oral mucositis. Supportive Care in Cancer, 15(4), 427–440.
RCT was designed to evaluate pain control and the ability to eat and drink using standard therapy (sucralfate and Mucaine® [Wyeth-Ayerst Laboratories]) versus Gelclair® (EKR Therapeutics, Inc.) in patients with radiotherapy-induced oral mucositis.
Patients used medication 30 minutes to 1 hour before eating or drinking.
Gelclair: Patients used undiluted or could mix a single dose in a glass with up to 40 ml of water. Patients swished and gargled for at least one minute to coat the tongue, roof of mouth, throat, and inside of cheeks. If unable to do that, patients used sponge applicators. Patients spat the product out and did not swallow it.
Sucralfate and Mucaine: Patients swished 10 ml in mouth for at least 1 minute to coat all areas, then swallowed the product.
Study was 24 hours only. Baseline was 1, 3, and 24 hours after initiation of treatment.
Patients in both groups had additional analgesia available throughout the trial.
Patients swallowed standard therapy but not Gelclair.
The sample was comprised of 20 patients (n = 10 in the Gelclair group and n = 10 in the standard [sucralfate and Mucaine] group).
Patients with head and neck cancer received daily radation therapy over a 4–6 week period and showed at least grade 1 oral mucositis and pain not alleviated by paracetamol, co-codamol, or aspirin.
The mean age was 61.1 years (range = 28-79 years).
Three patients were smokers.
Double-center, prospective RCT
Single blind trial with the administrating nurse specialist unaware of medication used
Conducted as feasibility study for future sample size calculation
Oral mucositis NCI-CTC for radiation
General pain and pain on speaking VAS 0–10
Swallowing assessment was self-recorded (normal to swallowing own saliva only).
Compliance was queried by the researcher.
Using NCI grading, nine patients had grade 3 or 4 (three in the intervention arm and six in the control arm). The remaining 11 patients had grade 1 or 2 (seven in the Gelclair group and four in the standard therapy group).
No observations of relevance with regard to general pain, pain on speaking, or ability to eat and drink for those with higher grades of oral mucositis.
Number of coanalgesics of strong opiate type
One patient was noncompliant for sucralfate and Mucaine.
General pain: No significant difference was observed between the intervention and the control group across time intervals (p = 0.236).
Reduction in pain on speaking was not significant (p = 0.616).
Swallow: Effects of standard therapy appeared to last longer than Gelclair (NS).
Because the study was only 24 hours, effectiveness with more severe mucositis is not known.