NCT02399228

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

Completed Phase 2 Results posted Last updated 19 November 2021

What this trial tests

Phase 2 trial testing 0.25% EISO mouth rinse in Oral Mucositis in 13 participants. Completed in 20 May 2017.

Timeline

4 October 2015

Primary endpoint
20 May 2017

20 May 2017

Quick facts

Lead sponsor	Santalis Pharmaceuticals, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	13
Start date	4 October 2015
Primary completion	20 May 2017
Estimated completion	20 May 2017
Sites	1 location across United States

Drugs / interventions tested

• 0.25% EISO mouth rinse — full drug profile →

Conditions studied

• Oral Mucositis — all drugs for Oral Mucositis →

Sponsor

Santalis Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Oral Mucositis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patients Achieving Less Than or Equal to "2" RTOG Score At Visit 9 Primary · Up to ten (10) weeks

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)-Ulceratio

Group	Value	95% CI
0.25% EISO Mouth Rinse	7

Subject Self Reporting Burning or Irritation Secondary · Up to ten (10) weeks

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

Group	Value	95% CI
0.25% EISO Mouth Rinse	4
0.25% EISO Mouth Rinse	4
0.25% EISO Mouth Rinse	3
0.25% EISO Mouth Rinse	2

NRPS (Numerical Rating Pain Scale) Secondary · Up to ten (10) weeks

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.

Group	Value	95% CI
0.25% EISO Mouth Rinse	3.875	± 2.75

Safety Will be Assessed Based on the Frequency and Severity of Adverse Events. Secondary · [ Time Frame: Up to ten (10) weeks ]

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 a

Nausea (Mild)

Group	Value	95% CI
0.25% EISO Mouth Rinse	2

Vomiting (Mild)

Group	Value	95% CI
0.25% EISO Mouth Rinse	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Over the course of the treatment (up to 10 weeks), which was while the patients were undergoing radiotherapy and chemo.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

0.25% EISO Mouth Rinse

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (36 terms — click to expand)

Reaction	System	0.25% EISO Mouth Rinse
Nausea	Gastrointestinal disorders	—
Dysgeusia	General disorders	—
Dry Mouth	General disorders	—
Fatigue	General disorders	—
Dermatitis Radiation	Skin and subcutaneous tissue disorders	—
Weight Loss	General disorders	—
Vomiting Grade 1	Gastrointestinal disorders	—
Dysphagia	General disorders	—
Insomnia	General disorders	—
Mucositis	Skin and subcutaneous tissue disorders	—
Anemia	Metabolism and nutrition disorders	—
Cough	General disorders	—
Creatinine Increased	Renal and urinary disorders	—
Dyspepsia	Gastrointestinal disorders	—
Ear Pain	Ear and labyrinth disorders	—
Hypoalbuminemia	General disorders	—
Hypocalcemia	Renal and urinary disorders	—
Hypomagnesemia	General disorders	—
Hyponatremia	General disorders	—
Lymphocyte count decreased	Immune system disorders	—
Mucosal Infection	Immune system disorders	—
Oral Pain	General disorders	—
Sore Throat	General disorders	—
White Blood Cell Decreased	Immune system disorders	—
Chills	General disorders	—
Constipation	General disorders	—
Dizziness	General disorders	—
Epistaxis	General disorders	—
Hyperpigmentation	Skin and subcutaneous tissue disorders	—
Hypokalemia	General disorders	—
Memory Impairment	Psychiatric disorders	—
Neutrophil Count Decreased	Immune system disorders	—
Otitis Externa	Eye disorders	—
Otitis Media	Eye disorders	—
Platelet Count Decreased	Immune system disorders	—
Tumor Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—

Data from ClinicalTrials.gov NCT02399228 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ionizing radiation: molecular mechanisms, biological effects, and therapeutic targets.
   Wei W, Ren Y, Lan J, Yi J, et al · · 2026 · PMID 41507636 · DOI 10.1186/s43556-025-00358-4