Trial Outcomes & Findings for A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Oral Mucositis (NCT NCT02399228)

Last Updated: 2021-11-19

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Up to ten (10) weeks

Results posted on

2021-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	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". 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
Overall Study STARTED	13
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.25% EISO Mouth Rinse n=13 Participants 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". 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	55.4 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to ten (10) weeks

Population: Not all subjects analyzed at visit 9 completed the trial. Therefore, the number of completed subjects (7) is less than the number of subjects analyzed for this endpoint.

Outcome measures

Outcome measures
Measure	0.25% EISO Mouth Rinse n=7 Participants 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". 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
Patients Achieving Less Than or Equal to "2" RTOG Score At Visit 9	7 Participants

SECONDARY outcome

Timeframe: Up to ten (10) weeks

Population: All subjects who reported tolerability at any point during the study were analyzed

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

Outcome measures

Outcome measures
Measure	0.25% EISO Mouth Rinse n=13 Participants 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". 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
Subject Self Reporting Burning or Irritation None	4 Participants
Subject Self Reporting Burning or Irritation Mild	4 Participants
Subject Self Reporting Burning or Irritation Moderate	3 Participants
Subject Self Reporting Burning or Irritation Severe	2 Participants

SECONDARY outcome

Timeframe: Up to ten (10) weeks

Population: ITT (Intention-to-treat)

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.

Outcome measures

Outcome measures
Measure	0.25% EISO Mouth Rinse n=13 Participants 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". 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
NRPS (Numerical Rating Pain Scale)	3.875 score on a scale Standard Deviation 2.75

OTHER_PRE_SPECIFIED outcome

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

Population: Only 4 patients reported adverse events possibly or probably related to the study product.

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.

Outcome measures

Outcome measures
Measure	0.25% EISO Mouth Rinse n=13 Participants 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". 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
Safety Will be Assessed Based on the Frequency and Severity of Adverse Events. Nausea (Mild)	2 participants
Safety Will be Assessed Based on the Frequency and Severity of Adverse Events. Vomiting (Mild)	2 participants

Adverse Events

0.25% EISO Mouth Rinse

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	0.25% EISO Mouth Rinse n=13 participants at risk 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". 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
Gastrointestinal disorders Nausea	46.2% 6/13 • Number of events 6 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Gastrointestinal disorders Vomiting Grade 1	23.1% 3/13 • Number of events 3 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Dysgeusia	46.2% 6/13 • Number of events 6 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Dry Mouth	38.5% 5/13 • Number of events 5 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Fatigue	38.5% 5/13 • Number of events 5 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Skin and subcutaneous tissue disorders Dermatitis Radiation	30.8% 4/13 • Number of events 4 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Weight Loss	30.8% 4/13 • Number of events 4 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Dysphagia	23.1% 3/13 • Number of events 3 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Insomnia	23.1% 3/13 • Number of events 3 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Skin and subcutaneous tissue disorders Mucositis	23.1% 3/13 • Number of events 3 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Metabolism and nutrition disorders Anemia	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Cough	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Renal and urinary disorders Creatinine Increased	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Gastrointestinal disorders Dyspepsia	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Ear and labyrinth disorders Ear Pain	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Hypoalbuminemia	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Renal and urinary disorders Hypocalcemia	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Hypomagnesemia	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Hyponatremia	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Immune system disorders Lymphocyte count decreased	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Immune system disorders Mucosal Infection	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Oral Pain	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Sore Throat	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Immune system disorders White Blood Cell Decreased	15.4% 2/13 • Number of events 2 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Chills	7.7% 1/13 • Number of events 1 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Constipation	7.7% 1/13 • Number of events 1 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Dizziness	7.7% 1/13 • Number of events 1 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Epistaxis	7.7% 1/13 • Number of events 1 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Skin and subcutaneous tissue disorders Hyperpigmentation	7.7% 1/13 • Number of events 1 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
General disorders Hypokalemia	7.7% 1/13 • Number of events 1 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Psychiatric disorders Memory Impairment	7.7% 1/13 • Number of events 1 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Immune system disorders Neutrophil Count Decreased	7.7% 1/13 • Number of events 1 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Eye disorders Otitis Externa	7.7% 1/13 • Number of events 1 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Eye disorders Otitis Media	7.7% 1/13 • Number of events 1 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Immune system disorders Platelet Count Decreased	7.7% 1/13 • Number of events 1 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	7.7% 1/13 • Number of events 1 • Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo. Adverse events were solicited from subjects through clinic visits and captured on daily diaries

Additional Information

Dr. Ying Li, M.D., Ph.D.

University of Texas Health Science Center at San Antonio

Phone: 210-450-1719

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60