Status:
COMPLETED
MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Malignant Neoplasm
Oral Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2022
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03469284
Start Date
February 28 2019
End Date
February 3 2022
Last Update
April 25 2023
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030