A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Oral Mucositis
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Intervention: 0.25% EISO mouth rinse
Intervention description: A mouth rinse to be used three times a day during the course of radiation and/or chemotherapy to prevent or minimize oral mucositis
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: radiation therapy; chemotherapy; head and neck cancer

Summary:

      The initial proposed clinical study will be conducted in adult head and neck cancer subjects.
      This will be an open-labeled, proof of concept trial to evaluate the efficacy, safety and
      tolerability of EISO in a form of oral rinse as adjunctive therapy to standard of care.
      Santalis believes that the proposed study is a prudent and appropriate approach to
      investigate the potential of their product to prevent or improve oral mucositis symptoms
      commonly seen in subjects undergoing radiotherapy with or without chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects with head and neck cancer involving the oropharynx or oral cavity, who are
             expected to undergo high dose radiation therapy (i.e., ≥ 60 Gy) that typically results
             in oral mucositis, with or without concurrent chemotherapy or biologic targeted
             therapy.

          2. At least 18 years of age

          3. Estimated survival of at least 6 months.

          4. No prior radiation therapy to the head and neck area, and no chemotherapy within the
             last year except for induction chemotherapy delivered (or to be delivered) prior to
             the current course of radiation therapy

          5. Female subjects of child-bearing potential must agree to use an adequate form of
             contraceptive (e.g., hormonal, barrier method or abstinence) prior to study entry and
             for the duration of the trial.

          6. Are willing to refrain from using other treatments for oral mucositis until they
             consult with the study investigator(s).

          7. Are able to give written informed consent in a manner approved by the Institutional
             Review Board and comply with the requirements of the study.

        Exclusion Criteria:

          1. Have preexisting mucositis from other causes.

          2. Are immunosuppressed or in chronic use of immunosuppressive drugs.

          3. Have a known sensitivity to any of the constituents of the test product including
             sensitivities to sandalwood oil, fragrances or any member of the Compositae family of
             vascular plants (e.g., sunflowers, daisies, dahlias, etc.).

          4. Eastern Cooperative Oncology Group (ECOG) performance status > 3

          5. Unwilling or unable to follow the protocol requirements.

          6. Have any condition that in the opinion of the investigator would confound the
             efficacy, safety and tolerability assessments, such as oral thrush.

          7. Have participated in any clinical trial in the previous 30 days.

          8. Are pregnant, breastfeeding, or unwilling to practice an acceptable form of birth
             control during the study.