MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

NCT03461354 | Terminated DMC

• 3 other identifiers: IRB0008136500024266LCI-HN-MUC-LOX-001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine if the administration of prophylactic MucoLox formulation versus sodium bicarbonate mouthwash in subjects with head/neck cancer receiving radiation ± chemotherapy will result in significantly fewer subjects experiencing severe mucositis.

Conditions

Mucositis Oral; Head and Neck Cancer

Keywords

Oral rinse; Chemotherapy and Radiation Side Effects

Outcome Measures

Primary Outcomes (1)

• AUC for the Oral Mucositis Daily Questionnaire mouth and throat soreness question #2

  To compare the area under the curve (AUC) for the Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness (MTS) question 2 (Q2) score over a one-month period in subjects receiving the MucoLox formulation versus sodium bicarbonate rinse (as the control) for the prevention of severe mucositis in subjects with head/neck cancer receiving radiation ± chemotherapy

  One month

Secondary Outcomes (7)

• Time to OMDQ MTS > 2

  One month

• Opioid use (morphine equivalent daily dose)

  Weekly during the one-month study period

• Assess remaining OMDQ questions

  One month

• Duration of symptom relief

  One month

• Frequency of chemoradiation delays

  One month

Other Outcomes (1)

• Drug-related adverse events

  One month

Study Arms (2)

A

EXPERIMENTAL

Mucolox Arm

Other: MucoLox

B

ACTIVE COMPARATOR

Sodium Bicarb Control Arm

Other: Sodium Bicarbonate

Interventions

MucoLox OTHER

MucoLox formulation, with MucoLox as the delivery vehicle, combined with preserved water, beta-glucan, dexpanthenol, and glutamine

A

Sodium Bicarbonate OTHER

Sodium bicarbonate oral rinse

B

Eligibility Criteria

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

You may qualify if:

• Subjects must meet all of the following criteria:
• Confirmed head/neck cancer scheduled to receive at least a 28-day course of radiation to the head/neck area (radiation field must include at least one mucosal site within the oral cavity space, oropharynx, hypopharynx or larynx). Subjects must be planned to receive a minimum cumulative dose of 40 Gy and maximum dose of 72 Gy of radiation. Subjects may or may not be scheduled to receive concomitant platinum-based chemotherapy administered with radiation
• At least 18 years of age
• ECOG performance status less than or equal to 2 or Karnofsky performance score greater than or equal to 70%.
• Able and willing to complete OMDQ as determined by the treating Investigator
• Able and willing to swish/spit the oral formulation as determined by the treating Investigator
• Able and willing to provide informed consent

You may not qualify if:

• Subjects must not meet any of the following criteria:
• Receiving any other pharmacological treatment within 1 week of initiation of study treatment for oral mucositis, excluding analgesics, antibiotics, antifungals, and hydration for symptom management. Subjects must also agree to not use any other mouthwash formulations to prevent or treat mucositis during the course of the study.
• The subject's enrolling investigator must agree to not prescribe any other mouthwash formulations to prevent or treat oral mucositis during protocol-directed treatment (Note: subjects may receive standard of care treatment if the subject develops oral mucositis and discontinues study treatment \[or may crossover to Arm A if randomized to Arm B\]).
• Subjects must also agree to not use any other mouthwash formulations to prevent or treat oral mucositis during protocol-defined treatment.
• i. Agents suggested to modify oral mucositis risk or course that are not allowed include sodium bicarbonate, magic mouthwash formulations, amifostine, benzydamine, cevimeline, glutamine rinse, topical GM-CSF, interleukin-11, chlorhexidine, hydrogen peroxide, diphenhydramine, palifermin, pilocarpine, steroid rinses, sucralfate, and various oral rinse medical devices
• Untreated or unresolved oral infections, including oral candidiasis or active lesions due to oral herpes simplex virus infection that in the opinion of the investigator would compromise study outcomes.
• Signs and symptoms of any mouth and/or throat condition or active dental disease that would impair the ability to administer the mouthwash and/or assess the development of oral mucositis, as determined by the Investigator.
• Presence of baseline grade \> 1 oral mucositis per WHO criteria as determined by the treating investigator
• Receiving chronic immunosuppression as determined by the Investigator
• Known hypersensitivity to any ingredients in the mouthwash formulations that may result in anaphylaxis.
• Use, or suspicion of use, of illicit drugs or substances (self-reported) that may, in the opinion of the Investigator, have a reasonable chance of contributing to non-compliance, opioid abuse, drug toxicity, and/or otherwise skewing the trial result

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Professional Compounding Centers of America: collaborator
• Atrium Health Levine Cancer Institute: collaborator

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Stomatitis; Head and Neck Neoplasms

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jai Patel, PharmD, BCOP

  Levine Cancer Institute, Atrium Health (formerly Carolinas HealthCare System)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 12, 2018
• Study Start: April 9, 2018
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)