Herbal Mouthrinse for Oral Mucositis Study
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study involves adults receiving radiation therapy for head and neck cancer and will test
      whether or not the study mouthrinse may lessen oral mucositis.
    

Detailed description: 
      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.
    

Intervention name(s): Neem Mouthrinse; Placebo Mouthrinse
Intervention type(s): Drug; Drug
Intervention description(s): 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.; 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Other intervention name(s): aloe; anise; ascorbic acid; clove; glycerin; extract of neem leaf; peppermint; poloxamer 407; potassium sorbate; spearmint; thyme; water; xylitol; aloe; anise; ascorbic acid; clove; glycerin; peppermint; poloxamer 407; potassium sorbate; spearmint; thyme; water; xylitol
Intervention MeSH terms: Ascorbic Acid; Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Oral; Mucositis; Stomatitis; Radiotherapy