Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Group 1 (lower dose methylene blue, standard of care)
Patients receive lower dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
Experimental
Group 2 (medium dose methylene blue, standard of care)
Patients receive medium dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
Experimental
Group 3 (higher dose methylene blue, standard of care)
Patients receive higher dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
Active comparator
Group 4 (standard of care)
Patients receive standard of care therapy.
Outcomes the sponsor listed as primary.
Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool
Time frame · Baseline up to day 7
Oral mucositis pain reduction (measured by using the Numeric Rating Scale (NRS); from 0, representing no pain, to 10, representing the worst possible pain) from baseline to 7 days post treatment. The pain scale is included in the Modified Harris mucositis-related pain assessment tool.
Change in Oral Function Burden (OFB) Scores
Time frame · Baseline up to day 7
Oral functioning (eat, swallow, talk: unable=2, difficulty=1, able=0. Oral functioning score is the total score of 3 categories, ranged 0-6). Scale is included in the Modified Harris mucositis-related pain assessment tool. Measurements are obtained at day 0, 1, 2, and 7. Modified Harris mucositis-related pain assessment tool. Lowest value=0 representing normal. Highest value =6 representing worst outcome.
World Health Organization Oral Mucositis Severity Grades
Time frame · Up to day 2
Used the WHO grading system (0= no mucositis, 3=severe mucositis) The clinical severity of the OM was documented only at enrollment point to the study. Most of the patients had the grade 3 mucositis (Soreness/erythema + ulceration + ability to use a liquid diet only), per World Health Organization criteria. See table below which indicates the description of the various grades. Grade Description 0 No changes 1. Soreness/erythema 2. Soreness/erythema + ulceration + ability to eat solid foods 3. Soreness/erythema + ulceration + ability to use a liquid diet only Secondary endpoint included oral functioning burden (0=normal, 6= worse oral function) (OFB; measured on a scale of 0, representing normal, to 6, meaning total inability, reflecting a total score of three categories: the ability to eat, swallow, and talk, each scored as unable = 2, difficult = 1, able = 0).
Morphine Equivalent Daily Doses (MEDD)
Time frame · Baseline to Day 2
Morphine equivalent daily dose (MEDD) used for oral mucositis pain at 2 post MB administration. Before the study was implemented, it was observed that many patients had pain resolved just within a few doses. Therefore, the study aimed to cover only 100 cc of MB, which typically last about 2 days. Some patients requested more MB after the two days which had to be provided by the pharmacy and ordered by the primary team and paid by patient insurance. This was considered out of the study, but the patients were still followed. Also, there was no average, only self-reported level of pain from the patient at point of data collection.
Pain Duration
Time frame · Up to 30-90 days
Measured the days the patient was in pain. The study aimed to cover only 100 cc of MB, which typically last about 2 days. Some patients requested more MB after the two days which had to be provided by the pharmacy and ordered by the primary team and paid by patient insurance. This was considered out of the study, but the patients were still followed. We followed for 30-90 days (no treatment for 30-90 days), only to observe for AEs. Also, there was no average, only self-reported level of pain from the patient at point of data collection.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Conventional Therapy (Controlled Arm) | 1.69 | 3.09 |
| Conventional Therapy + Methylene Blue (MB) 0.025% | 5.2 | 2.81 |
| Conventional Therapy + Methylene Blue (MB) 0.05% | 4.54 | 2.93 |
| Conventional Therapy + Methylene Blue (MB) 0.1% | 5.15 | 2.64 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Conventional Therapy (Controlled Arm) | 0.81 | 1.11 |
| Conventional Therapy + Methylene Blue (MB) 0.025% | 2.47 | 1.55 |
| Conventional Therapy + Methylene Blue (MB) 0.05% | 2.79 | 1.72 |
| Conventional Therapy + Methylene Blue (MB) 0.1% | 2.87 | 1.60 |
| Group | Value (Participants) |
|---|---|
| Conventional Therapy (Controlled Arm) | 1 |
| Conventional Therapy + Methylene Blue (MB) 0.025% | 0 |
| Conventional Therapy + Methylene Blue (MB) 0.05% | 1 |
| Conventional Therapy + Methylene Blue (MB) 0.1% | 4 |
| Group | Value (mg) |
|---|---|
| Conventional Therapy (Controlled Arm) | 117.5 |
| Conventional Therapy + Methylene Blue (MB) 0.025% | 115 |
| Conventional Therapy + Methylene Blue (MB) 0.05% | 107 |
| Conventional Therapy + Methylene Blue (MB) 0.1% | 120 |
| Group | Value (days) |
|---|---|
| Conventional Therapy (Controlled Arm) | 5.5 |
| Conventional Therapy + Methylene Blue (MB) 0.025% | 8 |
| Conventional Therapy + Methylene Blue (MB) 0.05% | 6 |
| Conventional Therapy + Methylene Blue (MB) 0.1% | 5 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Conventional Therapy (Controlled Arm)Participants receive standard of care therapy. | 0 / 16 | 0 / 16 | 0 / 16 |
| Conventional Therapy + Methylene Blue (MB) 0.025%Participants receive 0.025% dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy. | 1 / 15 | 0 / 15 | 0 / 15 |
| Conventional Therapy + Methylene Blue (MB) 0.05%Participants receive 0.05% dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy. | 0 / 14 | 0 / 14 | 0 / 14 |
| Conventional Therapy + Methylene Blue (MB) 0.1%Participants receive 0.1% dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy. | 0 / 15 | 0 / 15 | 0 / 15 |
Each cell reads participants affected / participants at risk, as the registry posted them.
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