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

NCT02399228 | Completed Phase 2 Results

• 1 other identifier: SAN005-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Keywords

radiation therapy; chemotherapy; head and neck cancer

Outcome Measures

Primary Outcomes (1)

• Patients Achieving Less Than or Equal to "2" RTOG Score At Visit 9

  The Radiation Therapy Oncology Group (RTOG) is the measure of anatomical changes associated with oral mucositis. Patients scores will be compared to historical data of patient progression. RTOG Scoring Criteria- Grade 0(none)- No change over baseline Grade 1(mild)- Irritation, may experience slight pain, not requiring analgesic Grade 2(moderate)- Patchy mucositis that may produce inflammatory serosanguinitis discharge; may experience moderate pain requiring analgesia Grade 3(severe) -Confluent, fibrinous mucositis, may include severe pain requiring narcotic Grade 4(life-threatening)-Ulceration, hemorrhage, or necrosis

  Up to ten (10) weeks

Secondary Outcomes (2)

• Subject Self Reporting Burning or Irritation

  Up to ten (10) weeks

• NRPS (Numerical Rating Pain Scale)

  Up to ten (10) weeks

Other Outcomes (1)

• Safety Will be Assessed Based on the Frequency and Severity of Adverse Events.

  [ Time Frame: Up to ten (10) weeks ]

Study Arms (1)

0.25% EISO Mouth Rinse

EXPERIMENTAL

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".

Drug: 0.25% EISO mouth rinse

Interventions

0.25% EISO mouth rinse 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

Also known as: East Indian sandalwood oil, Albuterpenoids

0.25% EISO Mouth Rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• At least 18 years of age
• Estimated survival of at least 6 months.
• 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
• 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.
• Are willing to refrain from using other treatments for oral mucositis until they consult with the study investigator(s).
• Are able to give written informed consent in a manner approved by the Institutional Review Board and comply with the requirements of the study.

You may not qualify if:

• Have preexisting mucositis from other causes.
• Are immunosuppressed or in chronic use of immunosuppressive drugs.
• 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.).
• Eastern Cooperative Oncology Group (ECOG) performance status \> 3
• Unwilling or unable to follow the protocol requirements.
• Have any condition that in the opinion of the investigator would confound the efficacy, safety and tolerability assessments, such as oral thrush.
• Have participated in any clinical trial in the previous 30 days.
• Are pregnant, breastfeeding, or unwilling to practice an acceptable form of birth control during the study.

Sponsors & Collaborators

• Santalis Pharmaceuticals, Inc.: lead
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

UTHSCSA Cancer Therapy and Research Center (CTRC)

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

• 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.

  PMID: 19028343 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Stomatitis; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Dr. Ying Li, M.D., Ph.D.
• Organization: University of Texas Health Science Center at San Antonio

liy8@uthscsa.edu

210-450-1719

Study Officials

• Paul Castella, PhD

  Santalis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 26, 2015
• Study Start: October 4, 2015
• Primary Completion: May 20, 2017
• Study Completion: May 20, 2017
• Last Updated: November 19, 2021
• Results First Posted: November 19, 2021

Record last verified: 2021-11

Locations

US (1)