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

Primary Purpose

Oral Mucositis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

0.25% EISO mouth rinse

About this trial

This is an interventional prevention trial for Oral Mucositis focused on measuring radiation therapy, chemotherapy, head and neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

UTHSCSA Cancer Therapy and Research Center (CTRC)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

0.25% EISO Mouth Rinse

Arm Description

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".

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subject Self Reporting Burning or Irritation

Calculated by the number and percentage of subjects self reporting irritation of grade 1 (mild) or higher.

NRPS (Numerical Rating Pain Scale)

Severity of pain in the oral cavity/oropharynx was measured using the numerical rating pain scale (NRPS) at each study visit. The NRPS is an 11-point scale from 0-10: 0 = No pain 10 = The most intense pain imaginable.

Full Information

NCT ID

NCT02399228

First Posted

March 17, 2015

Last Updated

November 16, 2021

Sponsor

Santalis Pharmaceuticals, Inc.

Collaborators

The University of Texas Health Science Center at San Antonio

1. Study Identification

Unique Protocol Identification Number

NCT02399228

Brief Title

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

Official Title

An Open-Label, Proof of Concept, Efficacy, Safety and Tolerability Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Prevention and Treatment of Oral Mucositis Induced by Radiation Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

October 4, 2015 (Actual)

Primary Completion Date

May 20, 2017 (Actual)

Study Completion Date

May 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Santalis Pharmaceuticals, Inc.

Collaborators

The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Mucositis

Keywords

radiation therapy, chemotherapy, head and neck cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.25% EISO Mouth Rinse

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

0.25% EISO mouth rinse

Other Intervention Name(s)

East Indian sandalwood oil, Albuterpenoids

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to ten (10) weeks

Secondary Outcome Measure Information:

Title

Subject Self Reporting Burning or Irritation

Description

Calculated by the number and percentage of subjects self reporting irritation of grade 1 (mild) or higher.

Time Frame

Up to ten (10) weeks

Title

NRPS (Numerical Rating Pain Scale)

Description

Time Frame

Up to ten (10) weeks

Other Pre-specified Outcome Measures:

Title

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

Description

Adverse Events (AEs) will be assessed in accordance the Common Terminology Criteria for Adverse Events (CTCAE). The number of patients experiencing adverse events possibly, or probably related to the study product will be reported. Possibly related: A clinical event, including laboratory test abnormality (if applicable), with a reasonable time sequence to administration of the drug, but which could also be explained by concurrent disease or other drugs or chemicals. Probably related: A clinical event, including laboratory test abnormality (if applicable), with a reasonable time sequence to administration of the drug, unlikely to be attributed to concurrent disease or other drugs or chemicals, and which follows a clinically reasonable response on withdrawal.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Castella, PhD

Organizational Affiliation

Santalis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

UTHSCSA Cancer Therapy and Research Center (CTRC)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19028343

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

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

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