LeukemiaPhase 3MATCHNCT06940570
Methadone as an Alternative Treatment for Children Underdoing HSCT
A Phase 3 study testing PCA plus methadone (Experimental) and PCA Alone (SOC) in people with Leukemia and Aplastic Anemia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Mucositis is a normal side effect of stem cell transplant which happens as a result of chemotherapy being given prior to a new donor cell infusion (bone marrow transplant). The chemotherapy will kill cancer cells, but good cells, such as those in the mouth, are killed too. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Leukemia, Aplastic Anemia, Bone Marrow Failure Syndromes
- What is being tested?
- PCA plus methadone (Experimental) and PCA Alone (SOC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2028to 1 Aug 2029
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All subjects admitted will receive a myeloablative conditioning regimen followed by autologous or allogeneic bone marrow transplant during transplant admission. Conditioning may include chemotherapy, radiation, or a combination of both methods to be determined by primary attending transplant physician. Diagnoses will include but not limited to those with liquid tumors, solid tumors, hematological/congenital blood disorders, or severe combined immunodeficiency syndromes.
- Subjects must be 6-18 years of age and demonstrate understanding of PCA use or have a parent available for PCA by proxy, meaning parent can push the button for the patient. Patient maximum age is 18 years old. PCA proxy in compliance with Pain Assessment and Management policy per institution.
- Performance status: Karnofsky/Lansky >50% prior to receiving conditioning.
- Be cognitively able to utilize and understand patient-controlled analgesia (PCA).
- Informed consent will be obtained from all participants or their parents or guardians, assent will be obtained from children ages 10-17 years of age per institutional policy.
Who cannot join
- QT prolongation prior to receiving myeloablative conditioning as evidenced by QTc being >450 for both girls and boys prior to starting methadone.
- Medical history of QT prolongation, VF, or VT.
- Patients on chronic pain medications on admission or have received more than 30 days of continuous opioids over the past month.
- Patients receiving a non-myeloablative regimen or no conditioning.
- Neurological or psychiatric condition that could confound reliable assessment of pain and sedation (non-verbal, global delay).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to morphine or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
- History of opioid misuse disorder OR opioid risk assessment tool score >8.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Single Center Trial to Determine the Efficacy of Methadone as a First Line Agent in the Reduction and Treatment of Pain in Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation
Mucositis is a normal side effect of stem cell transplant which happens as a result of chemotherapy being given prior to a new donor cell infusion (bone marrow transplant). The chemotherapy will kill cancer cells, but good cells, such as those in the mouth, are killed too. The mouth cells going away causes the areas in the mouth to be blistered, irritated, sore, and extremely painful. Pain medication (usually morphine or hydromorphone if allergic to morphine) are given when oral blisters are seen or felt by patient in patient's mouth. However, one pain medication given through a vein in the patient may or may not be effective and providers are often challenged with providing good pain control while waiting for the new donor cells to grow, which will then heal the mouth. This is a period of waiting that is 6-8 weeks.
The investigators know that methadone, a second pain medication, may decrease pain in a different way than morphine. This is because methadone works in a different way in the brain than morphine. By giving these pain medicines together, the hope of the study is to show decreased pain while waiting for new cells to grow.
Read more
The goal of this clinical trial is to hope to learn whether adding methadone (second pain medication) to the current pain medication which is morphine alone (all patients will receive this pain medication) will help reduce the pain experience of participant. Current treatment of morphine alone is sometimes not entirely effective and so any improvement of pain while waiting for new cells to grow is one of the goals of this study. If methadone is effective in decreasing pain, then patients may benefit in the future from using these two medications up front when getting a transplant.
Participant in this study between 6-18 years of age and is needing a stem cell transplant for a disease that can potentially be cured by transplantation.
Participant in this study is receiving chemotherapy and/or radiation conditioning that can cause mucositis. Participants are being asked to participate in this study because participants meet criteria to receive methadone that may or may not reduce pain experience versus just being given morphine alone, which is what all patients are given when the participants have mucositis.
The main goal of the study is to see if less opioid (pain medication) when methadone is added in comparison to participant who uses PCA only. The investigators also want to learn if patient's overall function is improved if given methadone. Another goal would be to see the number of TPN days the participant received and if the participant who was given methadone began to eat sooner. Other smaller goals include learning about side effects of methadone, and if the hospital stay is less for those who receive the study medication.
This medication will be given at Children's Medical Center of Dallas while participant is admitted for the stem cell transplant. There is no sponsor that is funding the study and this drug will be given free of charge in exchange for participation in the study
Read the detailed description
Given high reports of pain while despite receiving PCA during transplant, our current management of mucositis induced pain is suboptimal. In a study of children receiving transplantation, pain was a main concern for this cohort during and after transplantation. The investigators propose to conduct this study to determine if methadone used as a primary analgesic in patients with mucositis can improve the current standard of care which will be demonstrated by improved pain scores, maintenance of functionality, and recovery during and following HSCT. This study will be a single blind randomized controlled design. Patients will be randomly assigned by permuted block randomization in groups of eight. Patient will be randomly assigned to receive either basal/PCA of one opioid (control) in the first arm OR PCA plus methadone where methadone will be used as basal long-acting medication (experimental).
Study subjects will be children who are undergoing an autologous or allogeneic stem cell transplant receiving a myeloablative regimen and meet all inclusion criteria. This unique population is being studied as it is a controlled setting where the PI can anticipate pain in >90% of the patients following ablation, the number of patients who experience mucositis after receiving ablative conditioning. The study will only be conducted in the inpatient stem cell transplant setting and no follow up should be necessary when these subjects are discharged from the hospital after transplant.
The following goals of the study are as follows:
- Will the concomitant administration of intravenous administered methadone with on demand opioid PCA improve pain score numbers in the PCA/methadone arm (experimental) in comparison to a continuous infusion PCA with demand opioid arm (control, standard of care)?
- Will the administration of methadone with increased individualized titration result in a reduction of 25% in total morphine milligram equivalents (MME) in experimental versus control arm?
- Will the methadone experimental arm increase functionality during transplantation period?
- Will those receiving methadone have reduced TPN days during hospital stay as compared to control arm?
- Will the child resumes oral intake more rapidly compared to control arm?
- The investigators also want to describe adverse events and incidence associated with methadone when administered in combination with morphine or hydromorphone, specifically QTc prolongation that has been documented with study medication.
- Conditions
- Leukemia, Aplastic Anemia, Bone Marrow Failure Syndromes, SCID
- Being tested
- PCA plus methadone (Experimental), PCA Alone (SOC)
- Keywords
- intractable pain, methadone, mucositis, pediatric cancer, hematopoietic stem cell transplantation
- Medical subject headings
- Leukemia, Anemia, Aplastic, Bone Marrow Failure Disorders, Pain, Intractable, Mucositis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCA plus methadone (Experimental)Drug
Also called Addition of methadone to standard of care (SOC)
This study is novel. There are no other interventions to distinguish in this or another study.
PCA Alone (SOC)Drug
Also called Morphine OR Hydromorphone
PCA Alone (Control) arm. PCA opioid will include morphine OR hydromorphone (if patient has a sensitivity or is unable to tolerate or allergic to morphine).
| Study group | Role | What they receive |
|---|---|---|
| Group A: Control Arm (n = 30) | Active comparator | Pt will receive: PCA opioid will include morphine OR hydromorphone (if patient has a sensitivity or is unable to tolerate or allergic to morphine). This is the exclusive medication/opioid in this arm. The starting doses will be as follows:
* Starting dose for basal infusion of morphine is 0.02 mg/kg/hour up to a maximum of 50 kg.
* Starting PCA dose for morphine is 0.02 mg/kg every 15 minutes for a lockout of 0.1 mg/kg up to a maximum of 50 kg or ideal body weight (PCA starting dose should be no more than 1 mg/push and no more than 5 mg/hour lockout).
* Starting dose for basal infusion of hydromorphone is 0.003 mg/kg/hour up to a maximum of 50 kg IBW.
* Starting PCA dose for hydromorphone is 0.003 mg/kg every 15 minutes for an hourly maximum lockout of 0.012 mg/kg up to a maximum of 50 kg (PCA start
* PCA medications may be titrated up or down by 20-50% each day for desired analgesic effect with improved pain score, continue to engraftment or when medicine is no longer needed. Receives: Drug: PCA Alone (SOC) |
| Group B: Study or Experimental Arm (n = 30) | Experimental | The second arm will be methadone therapy that is scheduled to be given every 8 hours in addition to an on demand PCA. On demand PCA dosing will be the same as control arm but with NO basal/continuous rate. Intravenous methadone will be replacing basal infusion and serve as basal drug in place of continuous medication.
* Starting dose for intravenous methadone is 0.1 mg/kg IV Q8hr up to a maximum of 50 kg. Singular starting methadone will be maximum of 5 mg.
* Methadone may be increased by 20-50% every 48 hours due to half-life of medication. Reduction in analgesia will need to be monitored daily following a change. However, additional methadone increase should not occur until 48 hours have passed to allow for steady state of new dose to take effect. Reduction of methadone dosing by 20-50% can be made anytime per discretion of provider or if concerned about an adverse effect from the methadone.
This will continue until engraftment or until medicine is no longer needed. Receives: Drug: PCA plus methadone (Experimental) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pain score
The purpose of the study is to compare methadone versus standard of care at this center of morphine/hydromorphone PCA and see if methadone is superior to the standard of care as evidenced by reduction in pain scores during inpatient transplant.
To determine whether concomitant administration of intravenous administered methadone with on demand opioid PCA will improve pain score numbers in the PCA/methadone arm by 25% in comparison to a continuous infusion PCA with demand opioid arm.
Measured: Daily after completion of conditioning (day +7 to day +14) through discharge (approximately day +60)
Secondary outcomes (5)
REDUCTION OF OPIOID RECEIVED as evidenced by 25% reduction of MME in experimental arm in comparison to control arm
To determine if methadone (starting dose of 0.1 mg/kg IV Q8hr) with increased titration will result in a reduction of 25% in total morphine milligram equivalents (MME) per day in children who have mucositis following ablative conditioning and subsequent allogeneic or autologous HSCT
Measured: Daily after completion of conditioning (day +7 to day +14) through discharge (approximately day +60)
IMPROVEMENT OF FUNCTIONALITY as evidenced by higher functionality scores in experimental arm in comparison to control
To determine how administration of methadone affects functionality during transplantation period
Measured: Day 0 (stem cell infusion)
REDUCED NUMBER OF DAYS ON PARENTERAL NUTRITION as evidenced by reduced number of TPN days in experimental arm in comparison to control
To determine if the overall TPN days are reduced during hospital stay in experimental arm as compared to the standard PCA regimen
Measured: From enrollment (initiation of TPN- typically on day +1) to engraftment day AND date when able to take solid food again (day just prior to discharge-approx. day+50 to day+60)
INCREASED RETURN TO ORAL LIQUID INTAKE as evidenced by more rapid return to tolerating clears in experimental group versus control
To determine if child resumes oral intake more rapidly compared to control arm
Measured: From enrollment (initiation of TPN- typically on day +1) to engraftment day AND date when able to take solid food again (day just prior to discharge-approx. day+50 to day+60)
Adverse events
To describe adverse events and incidence associated with methadone when administered in combination with morphine or hydromorphone, specifically QTc prolongation that has been documented with study medication
Measured: From first dose of methadone administered (day +1- day +7) until prior to discharge (approximately day +60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Jan 2028 (estimated)
- Primary completionAug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Why it stopped: Study is closed with the IRB due to no funding. May resume once funding is obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized control study where pt is placed in one of two groups, methadone receiving plus PCA push only (experimental) OR PCA/continuous infusion without methadone (control)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James DeMasi, Children's Health
- Investigators
- Victor M Aquino, MD, Principal investigator, UT Southwestern Department of Pediatric Oncology and Stem Cell Transplant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940570
- Sponsor's protocol ID
- STU-2022-0876
- Acronym
- MATCH
- Status last verified
- Oct 2025
- First submitted
- 17 Mar 2025
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no reason to share individualized participant data in this study. My plan is to deidentify all data and all data will be anonymous.
Publications
Portenoy RK. Treatment of cancer pain. Lancet. 2011 Jun 25;377(9784):2236-47. doi: 10.1016/S0140-6736(11)60236-5.
PubMed 21704873Jacob E. Neuropathic pain in children with cancer. J Pediatr Oncol Nurs. 2004 Nov-Dec;21(6):350-7. doi: 10.1177/1043454204270251.
PubMed 15475472Habashy C, Springer E, Hall EA, Anghelescu DL. Methadone for Pain Management in Children with Cancer. Paediatr Drugs. 2018 Oct;20(5):409-416. doi: 10.1007/s40272-018-0304-2.
PubMed 30047027Vasquenza K, Ruble K, Chen A, Billett C, Kozlowski L, Atwater S, Kost-Byerly S. Pain Management for Children during Bone Marrow and Stem Cell Transplantation. Pain Manag Nurs. 2015 Jun;16(3):156-62. doi: 10.1016/j.pmn.2014.05.005. Epub 2014 Sep 26.
PubMed 25267531White MC, Hommers C, Parry S, Stoddart PA. Pain management in 100 episodes of severe mucositis in children. Paediatr Anaesth. 2011 Apr;21(4):411-6. doi: 10.1111/j.1460-9592.2010.03515.x. Epub 2011 Jan 21.
PubMed 21251145Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
PubMed 11932914Vagliano L, Feraut C, Gobetto G, Trunfio A, Errico A, Campani V, Costazza G, Mega A, Matozzo V, Berni M, Alberani F, Banfi MM, Martinelli L, Munaron S, Orlando L, Lubiato L, Leanza S, Guerrato R, Rossetti A, Messina M, Barzetti L, Satta G, Dimonte V. Incidence and severity of oral mucositis in patients undergoing haematopoietic SCT--results of a multicentre study. Bone Marrow Transplant. 2011 May;46(5):727-32. doi: 10.1038/bmt.2010.184. Epub 2010 Sep 6.
PubMed 20818449Tomlinson D, Judd P, Hendershot E, Maloney AM, Sung L. Measurement of oral mucositis in children: a review of the literature. Support Care Cancer. 2007 Nov;15(11):1251-1258. doi: 10.1007/s00520-007-0323-y. Epub 2007 Aug 28.
PubMed 17724620Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162.
PubMed 15108222Sonis ST. The pathobiology of mucositis. Nat Rev Cancer. 2004 Apr;4(4):277-84. doi: 10.1038/nrc1318. No abstract available.
PubMed 15057287Sirkia K, Hovi L, Pouttu J, Saarinen-Pihkala UM. Pain medication during terminal care of children with cancer. J Pain Symptom Manage. 1998 Apr;15(4):220-6. doi: 10.1016/s0885-3924(98)00366-2.
PubMed 9601156Scully C, Sonis S, Diz PD. Oral mucositis. Oral Dis. 2006 May;12(3):229-41. doi: 10.1111/j.1601-0825.2006.01258.x.
PubMed 16700732Schiessl C, Gravou C, Zernikow B, Sittl R, Griessinger N. Use of patient-controlled analgesia for pain control in dying children. Support Care Cancer. 2008 May;16(5):531-6. doi: 10.1007/s00520-008-0408-2. Epub 2008 Feb 15.
PubMed 18274785Rose-Ped AM, Bellm LA, Epstein JB, Trotti A, Gwede C, Fuchs HJ. Complications of radiation therapy for head and neck cancers. The patient's perspective. Cancer Nurs. 2002 Dec;25(6):461-7; quiz 468-9. doi: 10.1097/00002820-200212000-00010.
PubMed 12464838Pearson EC, Woosley RL. QT prolongation and torsades de pointes among methadone users: reports to the FDA spontaneous reporting system. Pharmacoepidemiol Drug Saf. 2005 Nov;14(11):747-53. doi: 10.1002/pds.1112.
PubMed 15918160
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single Center Trial to Determine the Efficacy of Methadone as a First Line Agent in the Reduction and Treatment of Pain in Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06940570
- Acronym / sponsor ID
- MATCH / STU-2022-0876
- Conditions
- Leukemia, Aplastic Anemia, Bone Marrow Failure Syndromes, SCID
- Keywords
- intractable pain, methadone, mucositis, pediatric cancer, hematopoietic stem cell transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study is closed with the IRB due to no funding. May resume once funding is obtained.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2028 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mucositis is a normal side effect of stem cell transplant which happens as a result of chemotherapy being given prior to a new donor cell infusion (bone marrow transplant). The chemotherapy will kill cancer cells, but good cells, such as those in the mouth, are killed too. The mouth cells going away causes the areas in the mouth to be blistered, irritated, sore, and extremely painful. Pain medication (usually morphine or hydromorphone if allergic to morphine) are given when oral blisters are seen or felt by patient in patient's mouth. However, one pain medication given through a vein in the patient may or may not be effective and providers are often challenged with providing good pain control while waiting for the new donor cells to grow, which will then heal the mouth. This is a period of waiting that is 6-8 weeks.
The investigators know that methadone, a second pain medication, may decrease pain in a different way than morphine. This is because methadone works in a different way in the brain than morphine. By giving these pain medicines together, the hope of the study is to show decreased pain while waiting for new cells to grow.
The goal of this clinical trial is to hope to learn whether adding methadone (second pain medication) to the current pain medication which is morphine alone (all patients will receive this pain medication) will help reduce the pain experience of participant. Current treatment of morphine alone is sometimes not entirely effective and so any improvement of pain while waiting for new cells to grow is one of the goals of this study. If methadone is effective in decreasing pain, then patients may benefit in the future from using these two medications up front when getting a transplant.
Participant in this study between 6-18 years of age and is needing a stem cell transplant for a disease that can potentially be cured by transplantation.
Participant in this study is receiving chemotherapy and/or radiation conditioning that can cause mucositis. Participants are being asked to participate in this study because participants meet criteria to receive methadone that may or may not reduce pain experience versus just being given morphine alone, which is what all patients are given when the participants have mucositis.
The main goal of the study is to see if less opioid (pain medication) when methadone is added in comparison to participant who uses PCA only. The investigators also want to learn if patient's overall function is improved if given methadone. Another goal would be to see the number of TPN days the participant received and if the participant who was given methadone began to eat sooner. Other smaller goals include learning about side effects of methadone, and if the hospital stay is less for those who receive the study medication.
This medication will be given at Children's Medical Center of Dallas while participant is admitted for the stem cell transplant. There is no sponsor that is funding the study and this drug will be given free of charge in exchange for participation in the study
Detailed description
Given high reports of pain while despite receiving PCA during transplant, our current management of mucositis induced pain is suboptimal. In a study of children receiving transplantation, pain was a main concern for this cohort during and after transplantation. The investigators propose to conduct this study to determine if methadone used as a primary analgesic in patients with mucositis can improve the current standard of care which will be demonstrated by improved pain scores, maintenance of functionality, and recovery during and following HSCT. This study will be a single blind randomized controlled design. Patients will be randomly assigned by permuted block randomization in groups of eight. Patient will be randomly assigned to receive either basal/PCA of one opioid (control) in the first arm OR PCA plus methadone where methadone will be used as basal long-acting medication (experimental).
Study subjects will be children who are undergoing an autologous or allogeneic stem cell transplant receiving a myeloablative regimen and meet all inclusion criteria. This unique population is being studied as it is a controlled setting where the PI can anticipate pain in >90% of the patients following ablation, the number of patients who experience mucositis after receiving ablative conditioning. The study will only be conducted in the inpatient stem cell transplant setting and no follow up should be necessary when these subjects are discharged from the hospital after transplant.
The following goals of the study are as follows:
- Will the concomitant administration of intravenous administered methadone with on demand opioid PCA improve pain score numbers in the PCA/methadone arm (experimental) in comparison to a continuous infusion PCA with demand opioid arm (control, standard of care)?
- Will the administration of methadone with increased individualized titration result in a reduction of 25% in total morphine milligram equivalents (MME) in experimental versus control arm?
- Will the methadone experimental arm increase functionality during transplantation period?
- Will those receiving methadone have reduced TPN days during hospital stay as compared to control arm?
- Will the child resumes oral intake more rapidly compared to control arm?
- The investigators also want to describe adverse events and incidence associated with methadone when administered in combination with morphine or hydromorphone, specifically QTc prolongation that has been documented with study medication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This will be a randomized control study where pt is placed in one of two groups, methadone receiving plus PCA push only (experimental) OR PCA/continuous infusion without methadone (control)
| Arm | Type | Receives |
|---|---|---|
| Group A: Control Arm (n = 30) | Active comparator | Drug: PCA Alone (SOC)Pt will receive: PCA opioid will include morphine OR hydromorphone (if patient has a sensitivity or is unable to tolerate or allergic to morphine). This is the exclusive medication/opioid in this arm. The starting doses will be as follows: * Starting dose for basal infusion of morphine is 0.02 mg/kg/hour up to a maximum of 50 kg. * Starting PCA dose for morphine is 0.02 mg/kg every 15 minutes for a lockout of 0.1 mg/kg up to a maximum of 50 kg or ideal body weight (PCA starting dose should be no more than 1 mg/push and no more than 5 mg/hour lockout). * Starting dose for basal infusion of hydromorphone is 0.003 mg/kg/hour up to a maximum of 50 kg IBW. * Starting PCA dose for hydromorphone is 0.003 mg/kg every 15 minutes for an hourly maximum lockout of 0.012 mg/kg up to a maximum of 50 kg (PCA start * PCA medications may be titrated up or down by 20-50% each day for desired analgesic effect with improved pain score, continue to engraftment or when medicine is no longer needed. |
| Group B: Study or Experimental Arm (n = 30) | Experimental | Drug: PCA plus methadone (Experimental)The second arm will be methadone therapy that is scheduled to be given every 8 hours in addition to an on demand PCA. On demand PCA dosing will be the same as control arm but with NO basal/continuous rate. Intravenous methadone will be replacing basal infusion and serve as basal drug in place of continuous medication. * Starting dose for intravenous methadone is 0.1 mg/kg IV Q8hr up to a maximum of 50 kg. Singular starting methadone will be maximum of 5 mg. * Methadone may be increased by 20-50% every 48 hours due to half-life of medication. Reduction in analgesia will need to be monitored daily following a change. However, additional methadone increase should not occur until 48 hours have passed to allow for steady state of new dose to take effect. Reduction of methadone dosing by 20-50% can be made anytime per discretion of provider or if concerned about an adverse effect from the methadone. This will continue until engraftment or until medicine is no longer needed. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- All subjects admitted will receive a myeloablative conditioning regimen followed by autologous or allogeneic bone marrow transplant during transplant admission. Conditioning may include chemotherapy, radiation, or a combination of both methods to be determined by primary attending transplant physician. Diagnoses will include but not limited to those with liquid tumors, solid tumors, hematological/congenital blood disorders, or severe combined immunodeficiency syndromes.
- Subjects must be 6-18 years of age and demonstrate understanding of PCA use or have a parent available for PCA by proxy, meaning parent can push the button for the patient. Patient maximum age is 18 years old. PCA proxy in compliance with Pain Assessment and Management policy per institution.
- Performance status: Karnofsky/Lansky >50% prior to receiving conditioning.
- Be cognitively able to utilize and understand patient-controlled analgesia (PCA).
- Informed consent will be obtained from all participants or their parents or guardians, assent will be obtained from children ages 10-17 years of age per institutional policy.
Key exclusion criteria (8 listed)
- QT prolongation prior to receiving myeloablative conditioning as evidenced by QTc being >450 for both girls and boys prior to starting methadone.
- Medical history of QT prolongation, VF, or VT.
- Patients on chronic pain medications on admission or have received more than 30 days of continuous opioids over the past month.
- Patients receiving a non-myeloablative regimen or no conditioning.
- Neurological or psychiatric condition that could confound reliable assessment of pain and sedation (non-verbal, global delay).
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 |
|---|---|---|
| PCA plus methadone (Experimental)Also: Addition of methadone to standard of care (SOC)This study is novel. There are no other interventions to distinguish in this or another study. | Drug | Group B: Study or Experimental Arm (n = 30) |
| PCA Alone (SOC)Also: Morphine OR HydromorphonePCA Alone (Control) arm. PCA opioid will include morphine OR hydromorphone (if patient has a sensitivity or is unable to tolerate or allergic to morphine). | Drug | Group A: Control Arm (n = 30) |
Primary outcome
Reduction of pain score
Time frame: Daily after completion of conditioning (day +7 to day +14) through discharge (approximately day +60)
The purpose of the study is to compare methadone versus standard of care at this center of morphine/hydromorphone PCA and see if methadone is superior to the standard of care as evidenced by reduction in pain scores during inpatient transplant. To determine whether concomitant administration of intravenous administered methadone with on demand opioid PCA will improve pain score numbers in the PCA/methadone arm by 25% in comparison to a continuous infusion PCA with demand opioid arm.
5 secondary outcomes
REDUCTION OF OPIOID RECEIVED as evidenced by 25% reduction of MME in experimental arm in comparison to control arm
Time frame: Daily after completion of conditioning (day +7 to day +14) through discharge (approximately day +60)
IMPROVEMENT OF FUNCTIONALITY as evidenced by higher functionality scores in experimental arm in comparison to control
Time frame: Day 0 (stem cell infusion)
REDUCED NUMBER OF DAYS ON PARENTERAL NUTRITION as evidenced by reduced number of TPN days in experimental arm in comparison to control
Time frame: From enrollment (initiation of TPN- typically on day +1) to engraftment day AND date when able to take solid food again (day just prior to discharge-approx. day+50 to day+60)
INCREASED RETURN TO ORAL LIQUID INTAKE as evidenced by more rapid return to tolerating clears in experimental group versus control
Time frame: From enrollment (initiation of TPN- typically on day +1) to engraftment day AND date when able to take solid food again (day just prior to discharge-approx. day+50 to day+60)
Adverse events
Time frame: From first dose of methadone administered (day +1- day +7) until prior to discharge (approximately day +60)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Background: PubMed 21704873Portenoy RK. Treatment of cancer pain. Lancet. 2011 Jun 25;377(9784):2236-47. doi: 10.1016/S0140-6736(11)60236-5.
- Background: PubMed 15475472Jacob E. Neuropathic pain in children with cancer. J Pediatr Oncol Nurs. 2004 Nov-Dec;21(6):350-7. doi: 10.1177/1043454204270251.
- Background: PubMed 30047027Habashy C, Springer E, Hall EA, Anghelescu DL. Methadone for Pain Management in Children with Cancer. Paediatr Drugs. 2018 Oct;20(5):409-416. doi: 10.1007/s40272-018-0304-2.
- Background: PubMed 25267531Vasquenza K, Ruble K, Chen A, Billett C, Kozlowski L, Atwater S, Kost-Byerly S. Pain Management for Children during Bone Marrow and Stem Cell Transplantation. Pain Manag Nurs. 2015 Jun;16(3):156-62. doi: 10.1016/j.pmn.2014.05.005. Epub 2014 Sep 26.
- Background: PubMed 21251145White MC, Hommers C, Parry S, Stoddart PA. Pain management in 100 episodes of severe mucositis in children. Paediatr Anaesth. 2011 Apr;21(4):411-6. doi: 10.1111/j.1460-9592.2010.03515.x. Epub 2011 Jan 21.
- Background: PubMed 11932914Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
- Background: PubMed 20818449Vagliano L, Feraut C, Gobetto G, Trunfio A, Errico A, Campani V, Costazza G, Mega A, Matozzo V, Berni M, Alberani F, Banfi MM, Martinelli L, Munaron S, Orlando L, Lubiato L, Leanza S, Guerrato R, Rossetti A, Messina M, Barzetti L, Satta G, Dimonte V. Incidence and severity of oral mucositis in patients undergoing haematopoietic SCT--results of a multicentre study. Bone Marrow Transplant. 2011 May;46(5):727-32. doi: 10.1038/bmt.2010.184. Epub 2010 Sep 6.
- Background: PubMed 17724620Tomlinson D, Judd P, Hendershot E, Maloney AM, Sung L. Measurement of oral mucositis in children: a review of the literature. Support Care Cancer. 2007 Nov;15(11):1251-1258. doi: 10.1007/s00520-007-0323-y. Epub 2007 Aug 28.
- Background: PubMed 15108222Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162.
- Background: PubMed 15057287Sonis ST. The pathobiology of mucositis. Nat Rev Cancer. 2004 Apr;4(4):277-84. doi: 10.1038/nrc1318. No abstract available.
- Background: PubMed 9601156Sirkia K, Hovi L, Pouttu J, Saarinen-Pihkala UM. Pain medication during terminal care of children with cancer. J Pain Symptom Manage. 1998 Apr;15(4):220-6. doi: 10.1016/s0885-3924(98)00366-2.
- Background: PubMed 16700732Scully C, Sonis S, Diz PD. Oral mucositis. Oral Dis. 2006 May;12(3):229-41. doi: 10.1111/j.1601-0825.2006.01258.x.
- Individual participant dataSharing planned: No. There is no reason to share individualized participant data in this study. My plan is to deidentify all data and all data will be anonymous.
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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.
Victor M Aquino, MD principal investigator
UT Southwestern Department of Pediatric Oncology and Stem Cell Transplant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PCA plus methadone (Experimental) and PCA Alone (SOC) in people with Leukemia and Aplastic Anemia, run by University of Texas Southwestern Medical 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 8 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: paused, as of the sponsor's last update on 23 Oct 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Reduction of pain score (time frame: Daily after completion of conditioning (day +7 to day +14) through discharge (approximately day +60)). 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 NCT06940570, which also lists 39 linked publications.
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 23 Oct 2025.