Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer

Overview

About this study

Evaluate the efficacy of methylene blue mouth wash for increasing oral intake and relieving pain in patients with oral mucositis related to cancer and/or cancer treatments.

Oral intake will improve after six doses of methylene blue mouthwash compared to usual care. Usual care is defined as the institutional standard of care at the study site which includes magic mouthwash (lidocaine/diphenhydramine/Maalox) and sodium bicarbonate oral rinse.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult patients (age 18 and over).
  • Active cancer diagnosis.
  • Admitted to the inpatient setting.
  • Grade 3-4 oral mucositis per the World Health Organization (WHO).
  • Grade 3: soreness and erythema, able to eat solid food.
  • Grade 4: soreness and erythema, able to tolerate liquid diet only.
  • Patient reports oropharyngeal pain.
  • Able to provide informed consent.

Exclusion Criteria:

  • Pediatric age (under 18 years old).
  • Any contraindication to methylene blue.
  • Pregnant women.

Eligibility last updated 10/25/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Regina Mackey, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20541617

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