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MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

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ClinicalTrials.gov Identifier: NCT03461354
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Professional Compounding Centers of America
Information provided by (Responsible Party):
Jai Patel, Atrium Health

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.

Condition or disease Intervention/treatment Phase
Mucositis Oral Head and Neck Cancer Drug: MucoLox Drug: Sodium Bicarbonate Phase 2

Detailed Description:
The primary objective of this double-arm, single-blinded, Phase II randomized study is 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. Secondary objectives include comparing the time to OMDQ MTS Q2 > 2 between the two arms; estimating and comparing opioid use defined as the average morphine equivalent daily dose (MEDD) at each clinic visit; assessing and comparing changes in the remaining OMDQ questions longitudinally throughout study; evaluating and comparing the duration of symptom relief in those who experience any degree of oral mucositis; evaluating and comparing the frequency of delays in [chemotherapy and/or radiation] therapy throughout the study period; and summarizing and comparing the prevalence and grade of oral mucositis at each clinic visit. The safety objective is to summarize the rates of potential side effects related to each oral formulation. A total of 60 eligible subjects will be enrolled and randomized in a 1:1 fashion to one of the treatment arms. Subjects on the control arm (sodium bicarbonate) who experience severe mucositis will have the option to crossover to the Mucolox arm for an additional 7 ± 2 days or until day 29 ± 5 days, whichever is longer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase II Randomized Trial of an Oral Formulation Containing a Mucoadhesive Polymer Hydrogel Vehicle (MucoLox®) to Mitigate Mucositis Symptoms in Head/Neck Cancer Patients Receiving Radiation ± Chemotherapy
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
Mucolox Arm
Drug: MucoLox
MucoLox formulation, with MucoLox as the delivery vehicle, combined with preserved water, beta-glucan, dexpanthenol, and glutamine

Active Comparator: B
Sodium Bicarb Control Arm
Drug: Sodium Bicarbonate
Sodium bicarbonate oral rinse




Primary Outcome Measures :
  1. AUC for the Oral Mucositis Daily Questionnaire mouth and throat soreness question #2 [ Time Frame: One month ]
    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


Secondary Outcome Measures :
  1. Time to OMDQ MTS > 2 [ Time Frame: One month ]
    To compare the time to OMDQ MTS Q2 > 2 between the two arms

  2. Opioid use (morphine equivalent daily dose) [ Time Frame: Weekly during the one-month study period ]
    To estimate opioid use defined as the average morphine equivalent daily dose (MEDD) at each clinic visit: baseline, day 8 ± 2, day 15 ± 2, day 22 ± 2, and the final study visit (day 29 ± 5) and compare between the two arms

  3. Assess remaining OMDQ questions [ Time Frame: One month ]
    To assess changes in the remaining OMDQ questions longitudinally throughout study treatment and compare between the two arms.

  4. Duration of symptom relief [ Time Frame: One month ]
    To evaluate and compare the duration of symptom relief in those who experience any degree of oral mucositis between the two arms

  5. Frequency of chemoradiation delays [ Time Frame: One month ]
    To evaluate the frequency of delays in [chemotherapy and/or radiation] therapy throughout the study period and compare between the two arms.

  6. Oral mucositis grade [ Time Frame: Weekly during the one month study period ]
    To summarize the prevalence and grade of oral mucositis at each clinic visit: baseline, day 8 ± 2, day 15 ± 2, day 22 ± 2, and the final study visit (day 29 ± 5), as assessed by the treating investigator using the WHO criteria for grading, and compare between the two arms.


Other Outcome Measures:
  1. Drug-related adverse events [ Time Frame: One month ]
    To summarize the rates of potential side effects related to each oral formulation, including but not limited to mouth discomfort, allergic reactions, exacerbation of mucositis symptoms, mouth ulcers, dry mouth, unpleasant taste or dysgeusia. Safety variables include AEs and SAEs related to the study treatment. Adverse events will be evaluated continuously throughout the study. Safety, tolerability, relationship to study treatment, and intensity will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Subjects must meet all of the following criteria:

  1. 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
  2. At least 18 years of age
  3. ECOG performance status less than or equal to 2 or Karnofsky performance score greater than or equal to 70%.
  4. Able and willing to complete OMDQ as determined by the treating Investigator
  5. Able and willing to swish/spit the oral formulation as determined by the treating Investigator
  6. Able and willing to provide informed consent

Exclusion Criteria

Subjects must not meet any of the following criteria:

  1. 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.

    1. 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]).
    2. 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

  2. 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.
  3. 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.
  4. Presence of baseline grade > 1 oral mucositis per WHO criteria as determined by the treating investigator
  5. Receiving chronic immunosuppression as determined by the Investigator
  6. Known hypersensitivity to any ingredients in the mouthwash formulations that may result in anaphylaxis.
  7. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461354


Contacts
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Contact: Tia Riley 704-403-0501 Tia.Riley@atriumhealth.org

Locations
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United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Tia Riley    704-403-0501    Tia.Riley@atriumhealth.org   
Principal Investigator: Jai N Patel, PharmD, BCOP         
Sponsors and Collaborators
Atrium Health
Professional Compounding Centers of America
Investigators
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Principal Investigator: Jai Patel, PharmD, BCOP Levine Cancer Institute, Atrium Health (formerly Carolinas HealthCare System)

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Responsible Party: Jai Patel, Chief, Pharmacology Research, Atrium Health
ClinicalTrials.gov Identifier: NCT03461354     History of Changes
Other Study ID Numbers: LCI-HN-MUC-LOX-001
00024266 ( Other Identifier: Advarra IRB )
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mucositis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases