A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Oral Mucositis

• Status: Completed
• Trial end date: 2017-05-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santalis Pharmaceuticals, Inc.
• Collaborator: The University of Texas Health Science Center at San Antonio

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. 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.