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Methylene Blue in Treating Patients with Cancer and Pain Associated with Oral Mucositis

Trial Status: Temporarily Closed to Accrual

This phase II trial studies how well methylene blue works in treating patients with cancer and pain associated with oral mucositis. Methylene blue may relieve pain associated with oral mucositis.

Inclusion Criteria

  • Patients with a cancer diagnosis, receiving chemotherapy, radiation therapy or the combination
  • Patients with a current diagnosis of oral mucositis
  • Patients with pain and oral dysfunction associated with oral mucositis despite conventional therapy
  • Voluntary written consent
  • Patient must agree to use of contraception or abstinence from sex during the treatment period and for 30 days after patient's last dose

Exclusion Criteria

  • Patients with known allergy to MB
  • Patients taking medications with known significant drug interactions
  • Pregnant or lactating patients
  • Patients who are cognitively impaired and unable to consent for the study
  • Patients with risk of broncho-aspiration based on documented swallowing test by a speech pathologist (if available)
  • Patients with known history of G6PD deficiency
  • Patients undergoing any other experimental intervention for oral mucositis
  • Patients who have no pain or impairment in oral function, patients who are not symptomatic
  • Patients with head and neck cancer
  • Patients on serotonergic drugs

Texas

Houston
M D Anderson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Carlos Roldan
Phone: 713-792-6070

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of methylene blue (MB) in reducing the severity of mucositis-related pain, measured by numeric rating scale (NRS), in cancer patients who underwent or are undergoing chemotherapy or radiation therapy.

OUTLINE: Patients are randomized to 1 of 4 groups.

GROUP 1: Patients receive lower dose methylene blue orally (PO) to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.

GROUP 2: Patients receive medium dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.

GROUP 3: Patients receive higher dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.

GROUP 4: Patients receive standard of care therapy. Patients may cross-over and be randomized to Groups 1-3 after the first 2 checkups.

After completion of study treatment, patients are followed up at 1, 2, 7, and 30 days.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Carlos Roldan

  • Primary ID 2016-1051
  • Secondary IDs NCI-2018-00822
  • Clinicaltrials.gov ID NCT03469284

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