MyelomaNCT03704597
Cryotherapy Against Oral Mucositis After High-dose Melphalan
A study testing cryotherapy in people with Myeloma and Mucositis, run by Sahlgrenska University Hospital.
Trial summary
In this prospective, randomised, controlled, open-label, Phase III, non-inferiority clinical trial trial patients with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 hours or 2 hours . Oral mucositis was evaluated prospectively. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myeloma, Mucositis, Cryotherapy Effect
- What is being tested?
- cryotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 30 Dec 2018
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: Cryotherapy as Prophylaxis Against Oral Mucositis After High-dose Melphalan and Autologous Stem Cell Transplantation for Myeloma: a Randomised, Open-label, Phase 3, Non-inferiority Trial Comparing Two and Seven Hours of Cryotherapy.
In this prospective, randomised, controlled, open-label, Phase III, non-inferiority clinical trial trial patients with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 hours or 2 hours . Oral mucositis was evaluated prospectively.
Read the detailed description
We searched MEDLINE and PubMed with the following phrases: "oral mucositis", "oral toxicity", "cryotherapy", "myeloma", "autologous haematopoietic stem cell transplantation", "randomised trial" and "high-dose melphalan".
Oral mucositis, which is a side effect of high-dose chemotherapy, has a major negative impact on the quality of life and survival of patients who undergoing autologous haematopoietic stem cell transplantation (auto-HSCT). For patients with myeloma cryotherapy gives a significant reduction in oral mucositis. The mechanism of action is suggested to be vasoconstriction that is induced by the cooling of the oral mucosa, thereby protecting it from the cytotoxic effects of the chemotherapy. The therapeutic efficacy of cryotherapy in this setting has been confirmed in several trials, it is currently regarded as the standard of care prophylactic regimen for oral mucositis in patients undergoing auto-HSCT for myeloma. However, the long duration of the treatment (7 hours), as reported in the original, placebo-controlled study in 2006, has been associated with significant discomfort for the patients, with negative consequences for compliance.
Uncontrolled trials have previously tested cryotherapy for less than 7 hours in patients with myeloma who receive auto-HSCT. At the time of the planning of the current study in 2014, those results were not yet confirmed in any randomised trial. However last year a randomised trial was published, showing that 2-hour cryotherapy is equally as effective as 6-hour cryotherapy in preventing oral mucositis in patients with myeloma who are treated with high-dose melphalan. The present prospective, randomised study aimed to investigate whether 2 hours of cryotherapy is as effective as 7 hours of cryotherapy in protecting against oral mucositis those patients who are subjected to high-dose melphalan as a conditioning agent for auto-SCT for myeloma.
- Conditions
- Myeloma, Mucositis, Cryotherapy Effect
- Being tested
- cryotherapy
- Medical subject headings
- Neoplasms, Plasma Cell, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyOther
Cooling of oral mucosa
| Study group | Role | What they receive |
|---|---|---|
| 7-hour cryotherapy | Active comparator | Standard of care Receives: Other: cryotherapy |
| 2-hour cryotherapy | Experimental | Experimental treatment Receives: Other: cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral mucositis WHO
Grades 3-4 oral mucositis
Measured: day 1-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 Mar 2014
- Primary completion1 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyelomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan-Erik Johansson, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704597
- Sponsor's protocol ID
- Sahlgrenska
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Johansson JE, Bratel J, Hardling M, Heikki L, Mellqvist UH, Hasseus B. Cryotherapy as prophylaxis against oral mucositis after high-dose melphalan and autologous stem cell transplantation for myeloma: a randomised, open-label, phase 3, non-inferiority trial. Bone Marrow Transplant. 2019 Sep;54(9):1482-1488. doi: 10.1038/s41409-019-0468-6. Epub 2019 Feb 4.
PubMed 30718802
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy as Prophylaxis Against Oral Mucositis After High-dose Melphalan and Autologous Stem Cell Transplantation for Myeloma: a Randomised, Open-label, Phase 3, Non-inferiority Trial Comparing Two and Seven Hours of Cryotherapy.
- ClinicalTrials.gov ID
- NCT03704597
- Acronym / sponsor ID
- Sahlgrenska
- Conditions
- Myeloma, Mucositis, Cryotherapy Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 15 Oct 2018 (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.
In this prospective, randomised, controlled, open-label, Phase III, non-inferiority clinical trial trial patients with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 hours or 2 hours . Oral mucositis was evaluated prospectively.
Detailed description
We searched MEDLINE and PubMed with the following phrases: "oral mucositis", "oral toxicity", "cryotherapy", "myeloma", "autologous haematopoietic stem cell transplantation", "randomised trial" and "high-dose melphalan".
Oral mucositis, which is a side effect of high-dose chemotherapy, has a major negative impact on the quality of life and survival of patients who undergoing autologous haematopoietic stem cell transplantation (auto-HSCT). For patients with myeloma cryotherapy gives a significant reduction in oral mucositis. The mechanism of action is suggested to be vasoconstriction that is induced by the cooling of the oral mucosa, thereby protecting it from the cytotoxic effects of the chemotherapy. The therapeutic efficacy of cryotherapy in this setting has been confirmed in several trials, it is currently regarded as the standard of care prophylactic regimen for oral mucositis in patients undergoing auto-HSCT for myeloma. However, the long duration of the treatment (7 hours), as reported in the original, placebo-controlled study in 2006, has been associated with significant discomfort for the patients, with negative consequences for compliance.
Uncontrolled trials have previously tested cryotherapy for less than 7 hours in patients with myeloma who receive auto-HSCT. At the time of the planning of the current study in 2014, those results were not yet confirmed in any randomised trial. However last year a randomised trial was published, showing that 2-hour cryotherapy is equally as effective as 6-hour cryotherapy in preventing oral mucositis in patients with myeloma who are treated with high-dose melphalan. The present prospective, randomised study aimed to investigate whether 2 hours of cryotherapy is as effective as 7 hours of cryotherapy in protecting against oral mucositis those patients who are subjected to high-dose melphalan as a conditioning agent for auto-SCT for myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7-hour cryotherapy | Active comparator | Other: cryotherapyStandard of care |
| 2-hour cryotherapy | Experimental | Other: cryotherapyExperimental treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| cryotherapyCooling of oral mucosa | Other | 2-hour cryotherapy, 7-hour cryotherapy |
Primary outcome
Oral mucositis WHO
Time frame: day 1-14
Grades 3-4 oral mucositis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 30718802Johansson JE, Bratel J, Hardling M, Heikki L, Mellqvist UH, Hasseus B. Cryotherapy as prophylaxis against oral mucositis after high-dose melphalan and autologous stem cell transplantation for myeloma: a randomised, open-label, phase 3, non-inferiority trial. Bone Marrow Transplant. 2019 Sep;54(9):1482-1488. doi: 10.1038/s41409-019-0468-6. Epub 2019 Feb 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy in people with Myeloma and Mucositis, run by Sahlgrenska University Hospital.
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Oral mucositis WHO (time frame: day 1-14). 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 NCT03704597, 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 15 Oct 2018; AzTrials last refreshed its copy on 31 Oct 2026.