Clinical trial NCT03469284: MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)
Official title: Randomized Controlled Trial Comparing 4 Intervention Arms, Including 3 Different Concentrations of Methylene Blue Oral Rinse Combined With Conventional Therapy and Conventional Therapy, in Patients With Intractable Pain Associated With Oral Mucositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Neoplasm
Oral Pain
Stomatitis
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVES:

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool
timeFrame: Baseline up to day 7
Secondary outcomes:
measure: Change in Oral Function Burden (OFB) Scores
timeFrame: Baseline up to day 7
measure: World Health Organization Oral Mucositis Severity Grades
timeFrame: Up to day 2
measure: Morphine Equivalent Daily Doses (MEDD)
timeFrame: Baseline to Day 2
measure: Pain Duration
timeFrame: Up to 30-90 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Carlos Roldan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roldan CJ, Huh B, Song J, Nieto Y, Osei J, Chai T, Nouri K, Koyyalagunta L, Bruera E. Methylene blue for intractable pain from oral mucositis related to cancer treatment: a randomized phase 2 clinical trial. BMC Med. 2022 Nov 3;20(1):377. doi: 10.1186/s12916-022-02579-8.