Malignant NeoplasmPhase 2NCT03469284
MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)
A Phase 2 study testing Best Practice and Methylene Blue in people with Malignant Neoplasm and Oral Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm, Oral Pain, Stomatitis
- What is being tested?
- Best Practice and Methylene Blue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2019to 3 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Malignant Neoplasm, Oral Pain, Stomatitis
- Being tested
- Best Practice, Methylene Blue
- Medical subject headings
- Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Given standard of care therapy
Methylene BlueDrug
Also called Azul de Metileno, Azul Metile, Blu di Metilene, CI Basic Blue 9
Given lower dose PO
Methylene BlueDrug
Also called Azul de Metileno, Azul Metile, Blu di Metilene, CI Basic Blue 9
Given medium dose PO
Methylene BlueDrug
Also called Azul de Metileno, Azul Metile, Blu di Metilene, CI Basic Blue 9
Given higher dose PO
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (lower dose methylene blue, standard of care) | Experimental | Patients receive lower dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy. Receives: Other: Best Practice; Drug: Methylene Blue |
| Group 2 (medium dose methylene blue, standard of care) | Experimental | Patients receive medium dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy. Receives: Other: Best Practice; Drug: Methylene Blue |
| Group 3 (higher dose methylene blue, standard of care) | Experimental | Patients receive higher dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy. Receives: Other: Best Practice; Drug: Methylene Blue |
| Group 4 (standard of care) | Active comparator | Patients receive standard of care therapy. Receives: Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool
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.
Measured: Baseline up to day 7
Secondary outcomes (4)
Change in Oral Function Burden (OFB) Scores
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.
Measured: Baseline up to day 7
World Health Organization Oral Mucositis Severity Grades
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
- Soreness/erythema
- Soreness/erythema + ulceration + ability to eat solid foods
- 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).
Measured: Up to day 2
Morphine Equivalent Daily Doses (MEDD)
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.
Measured: Baseline to Day 2
Pain Duration
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.
Measured: Up to 30-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start28 Feb 2019
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Roldan, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469284
- Sponsor's protocol ID
- 2016-1051
- Other IDs
- NCI-2018-00822, 2016-1051
- Status last verified
- Apr 2023
- First submitted
- 13 Mar 2018
- Last updated
- 25 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 36324139
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03469284
- Acronym / sponsor ID
- 2016-1051
- Conditions
- Malignant Neoplasm, Oral Pain, Stomatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 21 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (lower dose methylene blue, standard of care) | Experimental | Other: Best Practice, Drug: Methylene BluePatients receive lower dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy. |
| Group 2 (medium dose methylene blue, standard of care) | Experimental | Other: Best Practice, Drug: Methylene BluePatients receive medium dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy. |
| Group 3 (higher dose methylene blue, standard of care) | Experimental | Other: Best Practice, Drug: Methylene BluePatients receive higher dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy. |
| Group 4 (standard of care) | Active comparator | Other: Best PracticePatients receive standard of care therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyGiven standard of care therapy | Other | Group 1 (lower dose methylene blue, standard of care), Group 2 (medium dose methylene blue, standard of care), Group 3 (higher dose methylene blue, standard of care), Group 4 (standard of care) |
| Methylene BlueAlso: Azul de Metileno, Azul Metile, Blu di Metilene, CI Basic Blue 9Given lower dose PO | Drug | Group 1 (lower dose methylene blue, standard of care) |
| Methylene BlueAlso: Azul de Metileno, Azul Metile, Blu di Metilene, CI Basic Blue 9Given medium dose PO | Drug | Group 2 (medium dose methylene blue, standard of care) |
| Methylene BlueAlso: Azul de Metileno, Azul Metile, Blu di Metilene, CI Basic Blue 9Given higher dose PO | Drug | Group 3 (higher dose methylene blue, standard of care) |
Primary outcome
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.
4 secondary outcomes
Change in Oral Function Burden (OFB) Scores
Time frame: Baseline up to day 7
World Health Organization Oral Mucositis Severity Grades
Time frame: Up to day 2
Morphine Equivalent Daily Doses (MEDD)
Time frame: Baseline to Day 2
Pain Duration
Time frame: Up to 30-90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36324139Roldan 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.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Roldan principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Best Practice and Methylene Blue in people with Malignant Neoplasm and Oral Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.