Trotti, A., Garden, A., Warde, P., Symonds, P., Langer, C., Redman, R., et al. (2004). A multinational, randomized phase III trial of iseganan HCl oral solution for reducing the severity of oral mucositis in patients receiving radiotherapy for head-and-neck malignancy. International Journal of Radiation Oncology, Biology, Physics, 58(3), 674–681.

Iseganan HCL oral solution for reduction of severity of oral mucositis in patients receiving radiotherapy for head and neck malignancy.

9 mg doses of iseganan plus institute-specific standard of care (SOC) management of oral hygiene, or placebo plus SOC, or SOC alone (n = 81) in a 3;2;1 distribution. Drug administered within three days before and not more than two days after start RT and continued daily until last day of RT.

The study was comprised of 505 patients, ≥18 years old, with a median range of 56–58 years.

9 mg doses of iseganan plus institute-specific standard of care (SOC) management of oral hygiene (n = 253). 

Placebo plus SOC (n = 171)

SOC alone (n = 81)

Head and neck cancer, scheduled to receive minimum of 60 Gy to no less than three protocol specified anatomic sites each a min of 2 cm² area of mucosa.
 

Multi-site: 53 institutions US, Canada, France, Germany, UK

July 2000 – Dec 2001

RCT

Double blind if study drug or placebo

NCI-CTC radiation mucositis scale, pain, and difficulty swallowing (0 – 10)
Saliva samples for quantitative and qualitative microbiologic assessments
Assessments performed twice weekly during RT and four and eight weeks after completion.
 

No difference between iseganan and placebo groups for any study endpoint.

Iseganan group – fewer developed ulcerative OM and experienced less severe OM than SOC alone, also smaller proportion of placebo group developed ulcerative OM than SOC alone.

Emphasis on oral rinsing or the vehicle solution used may significantly reduce the incidence and severity of RT-induced ulcerative OM and associated clinical outcomes.

 

No positive effect

Study concludes with statement that “iseganan oral solution is safe and well tolerated in patients with compromised oral mucosa while receiving RT for head and neck cancer. Investigations with iseganan in clinical settings where infection is a known and significant factor should continue.” However, the treatment effect was not significant.

Sponsored by IntraBiotics Pharmaceuticals – R. Redman and H. Fuchs are employees of IntraBiotics; some authors were paid consultants.

No positive effect

Contributes to mixed findings regarding antimicrobial agents and mucositis