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

NCT ID: NCT02399228

Last Updated: 2021-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-04
• Study Completion Date: 2017-05-20

Brief 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.

Detailed Description

The objectives of this proof of concept trial are: to evaluate the efficacy, safety and tolerability of SAN005 when administered to adults for the prevention and treatment of radiation induced oral mucositis.

Subjects will be instructed on the administration of study medication thrice daily till oral mucositis resolves. Subjects will return to the clinic once a week while receiving radiation and then once every two weeks once their radiation has been completed and then until their mucositis has resolved for the Final Study Visit.

Preliminary Efficacy Evaluation will be the severity of pain rated by the Numeric Pain Rating Scale (NRPS) and mucositis grade by Radiation Therapy Oncology Group (RTOG) criteria at Visit 7 (Day 36). Additional secondary efficacy evaluations will include the severity of pain rated by the NRPS and mucositis grade by RTOG criteria at each study visit, frequency of the percutaneous endoscopic gastrostomy (PEG) tube for feeding during the duration of treatment and weight loss from baseline through Visit 5 and 7. The time of mucositis onset and duration will also be used in assessing efficacy. Additional secondary and exploratory endpoints will be outlined in the statistical analysis plan. The overall efficacy is determined by comparing the data to historical controls. Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug. In addition, tolerability evaluations will be performed at each study visit.

Conditions

Oral Mucositis

Keywords

radiation therapy; chemotherapy; head and neck cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

0.25% EISO Mouth Rinse

A mouth rinse containing 0.25% East Indian sandalwood oil (EISO), a candidate botanical drug substance. The rinse will be used three times a day for up to ten weeks. The material will not be ingested but used to "swish, gargle and spit".

Group Type: EXPERIMENTAL

0.25% EISO mouth rinse

Intervention Type: DRUG

A mouth rinse to be used three times a day during the course of radiation and/or chemotherapy to prevent or minimize oral mucositis

Interventions

0.25% EISO mouth rinse

A mouth rinse to be used three times a day during the course of radiation and/or chemotherapy to prevent or minimize oral mucositis

Intervention Type: DRUG

Other Intervention Names

East Indian sandalwood oil, Albuterpenoids

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: collaborator

Santalis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Castella, PhD

Role: STUDY_DIRECTOR

Santalis Pharmaceuticals

Locations

UTHSCSA Cancer Therapy and Research Center (CTRC)

San Antonio, Texas, United States

Countries

United States

References

Rosenthal DI, Trotti A. Strategies for managing radiation-induced mucositis in head and neck cancer. Semin Radiat Oncol. 2009 Jan;19(1):29-34. doi: 10.1016/j.semradonc.2008.09.006.

Reference Type: BACKGROUND

PMID: 19028343 (View on PubMed)

Singh CU NJ, inventors. : Derivatives of sandalwood oil and santalols for treating cold sores and herpes. . US patent application publication US2008/0058413 A1. 06 2008

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

SAN005-01

Identifier Type: -

Identifier Source: org_study_id