Herbal Mouthrinse for Oral Mucositis Study

The broad goal of our research is development of an effective Complementary and Alternative
Medicine (CAM) approach to prevent mucositis or lessen its severity and complications. Oral
mucositis (OM) is a clinically challenging and debilitating side effect of conventional
radiotherapy (RT), affecting almost all patients undergoing RT for head and neck cancer. OM
includes inflammation of the oral mucosa with or without opportunistic microbial infection.
It ranges from mild erythema to severe ulceration accompanied by persistent pain leading to
inability to tolerate or swallow food and fluids. OM frequently causes unwanted cancer
treatment dose reductions or breaks in therapy. Despite use of pain medications, severe OM
is associated with substantially increased use of costly health care resources. Presently,
there are no effective treatments for OM. The primary aim of the current proposal is to
determine whether or not a mouthrinse containing an herbal extract with known
anti-inflammatory and anti-microbial medicinal properties, will reduce the severity of oral
mucositis in cancer patients undergoing conventional radiotherapy to the head and neck.
Because of the prominent inflammatory and microbial aspects of OM we anticipate that the
herbal mouthrinse will reduce the severity of the pain and secondary infections associated
with OM, and will improve the quality of life in head and neck cancer patients undergoing
RT. Therefore, the specific aims of our Phase II double-blind, randomized, controlled trial
are 1) to determine if the severity of oral mucositis is reduced in RT patients receiving
the herbal mouthrinse compared to patients receiving the comparison mouthrinse and 2) to
determine the effects of the herbal mouthrinse on the microbial environment of the oral
cavity and on quality of life. Findings from this study will provide evidence to support
more in-depth biological assessment of the anti-inflammatory and anti-microbial mechanisms
by which the herbal extract reduces oral mucositis, and additional study in other
populations experiencing mucositis.

Inclusion Criteria:

- Anatomic site: lip (inner aspect), oral cavity, pharynx or larynx; includes tonsils
and salivary glands (ICD-9: 140-149 or 161).

- Malignant tumor: ICD-O morphology 2 (in situ) or 3 (malignant, invasive or
infiltrating).

- Adult aged 18-89 years.

- Patient recommended or planned to undergo radiotherapy to the head and neck regions,
as part of their cancer treatment regimen.

- Radiotherapy to be given in standard doses over a 4 - 7 week period.

Exclusion Criteria:

- Prior radiation treatment for cancer of the oral cavity, head or neck.

- Baseline mouth and throat soreness (MTS) extreme score of 4.

- Eastern Cooperative Oncology Group (ECOG) performance status >2.

- Unable to sign Informed Consent.

- Known history of allergy to any of the mouthrinse constituents (aloe, anise, ascorbic
acid, clove, glycerin, peppermint, poloxamer 407, potassium sorbate, spearmint,
thyme, water, xylitol).

- Inability to use a mouth rinse.

- Patient unable to communicate with study personnel in English (either themselves or
an interpreter).