MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | February 28, 2019 |
| End Date: | February 25, 2021 |
| Contact: | Carlos Roldan |
| Email: | croldan@mdanderson.org |
| Phone: | 713-792-6070 |
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
This early phase I trial studies how well methylene blue works in treating participants with
cancer and pain associated with oral mucositis. Methylene blue may relieve pain associated
with oral mucositis.
cancer and pain associated with oral mucositis. Methylene blue may relieve pain associated
with oral mucositis.
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: Participants are randomized to 1 of 4 groups.
GROUP 1: Participants 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: Participants receive medium dose methylene blue PO to swish and spit for 5 minutes
every 6 hours then receive standard of care therapy.
GROUP 3: Participants receive higher dose methylene blue PO to swish and spit for 5 minutes
every 6 hours then receive standard of care therapy.
GROUP 4: Participants receive standard of care therapy.
After completion of study treatment, participants are followed up at 1, 2, 7, and 30 days.
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: Participants are randomized to 1 of 4 groups.
GROUP 1: Participants 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: Participants receive medium dose methylene blue PO to swish and spit for 5 minutes
every 6 hours then receive standard of care therapy.
GROUP 3: Participants receive higher dose methylene blue PO to swish and spit for 5 minutes
every 6 hours then receive standard of care therapy.
GROUP 4: Participants receive standard of care therapy.
After completion of study treatment, participants are followed up at 1, 2, 7, and 30 days.
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
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Carlos Roldan
Phone: 713-792-6070
Click here to add this to my saved trials
