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Mucositis OralNCT03461354

MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

A study testing MucoLox and Sodium Bicarbonate in people with Mucositis Oral and Head and Neck Cancer, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mucositis Oral, Head and Neck Cancer
What is being tested?
MucoLox and Sodium Bicarbonate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteUnited States
Study dates
9 Apr 2018to 1 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
MucoLox, Sodium Bicarbonate
Keywords
Oral rinse, Chemotherapy and Radiation Side Effects
Medical subject headings
Stomatitis, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MucoLoxOther

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

  • Sodium BicarbonateOther

    Sodium bicarbonate oral rinse

Study groups in NCT03461354
Study groupRoleWhat they receive
AExperimentalMucolox Arm
Receives: Other: MucoLox
BActive comparatorSodium Bicarb Control Arm
Receives: Other: Sodium Bicarbonate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: One month

Secondary outcomes (7)

  1. Time to OMDQ MTS > 2

    To compare the time to OMDQ MTS Q2 > 2 between the two arms

    Measured: One month

  2. Opioid use (morphine equivalent daily dose)

    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

    Measured: Weekly during the one-month study period

  3. Assess remaining OMDQ questions

    To assess changes in the remaining OMDQ questions longitudinally throughout study treatment and compare between the two arms.

    Measured: One month

  4. Duration of symptom relief

    To evaluate and compare the duration of symptom relief in those who experience any degree of oral mucositis between the two arms

    Measured: One month

  5. Frequency of chemoradiation delays

    To evaluate the frequency of delays in [chemotherapy and/or radiation] therapy throughout the study period and compare between the two arms.

    Measured: One month

  6. Oral mucositis grade

    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.

    Measured: Weekly during the one month study period

  7. Comparison of self-reported OMDQ scores versus investigator-assessed mucositis

    The Generalized McNemar's test will be used to analyze correlation between patient report OMDQ Q2 scores and oral mucositis grading assessed by treating investigator using WHO criteria.

    Measured: Weekly during the one month study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2018
  2. Study start9 Apr 2018
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2024

Why it stopped: Interim analysis indicated study closure

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03461354
Sponsor's protocol ID
IRB00081365
Other IDs
00024266, LCI-HN-MUC-LOX-001
Status last verified
Feb 2025
First submitted
27 Feb 2018
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MucoLox and Sodium Bicarbonate in people with Mucositis Oral and Head and Neck Cancer, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Interim analysis indicated study closure). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC for the Oral Mucositis Daily Questionnaire mouth and throat soreness question #2 (time frame: One month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03461354.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.

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