Oral MucositisNCT01789658
Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
A study testing Cryotherapy in people with Oral Mucositis and Pain, run by Uppsala University at 5 sites in Sweden.
Trial summary
Oral mucositis (OM) is a common adverse effect of chemotherapy, radiotherapy and conditioning regimens before Hematopoietic Stem Cell Transplantation (HSCT). The aim of this study is to effectiveness of cryotherapy as a prophylactic treatment in children undergoing HSCT. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Oral Mucositis, Pain, Infection
- 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
- 53 participants
- Where
- 5 sitesSweden
- Study dates
- Oct 2012to Oct 2016
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 4-18 Undergoing Hematopoietic Stem Cell Transplantation in Sweden sufficient knowledge in swedish to understand the protocols -
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Pediatric Oncology Department, Queen Silvia Childrens´ Hospital
Gothenburg, SE-41685
Departent of Pediatric Oncology, Lund University Hospital
Lund, SE-22185
Center for Allogeneic Stem Cell Transplantation, Karolinska University Hospital, Hudding
Stockholm, SE-14186
Department of pediatrics B78, Karolinska University Hospital
Stockholm, Se-14186
Department of Hematology, Uppsala University Hospital
Uppsala, SE-75185
About this study
Official title: A Randomized Controlled Trial of Cryotherapy for Prevention and Reduction of Severity of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation.
Oral mucositis (OM) is a common adverse effect of chemotherapy, radiotherapy and conditioning regimens before Hematopoietic Stem Cell Transplantation (HSCT). The aim of this study is to effectiveness of cryotherapy as a prophylactic treatment in children undergoing HSCT.
Read the detailed description
There is a complex pathobiology behind OM; chemo and radiotherapy affects the mucosa and submucosa causing DNA-strand brakes and generation of reactive oxygen species (ROS). This initiates a cascade of events, among others activation of transcription factors, up-regulation of pro-inflammatory cytokines, and activation of macrophages and proteases leading to tissue injury causing symptoms such as erythema, edema, ulceration, taste perception alterations, and mouth dryness. OM often causes local and systemic infections, fatigue, pain, and difficulties in basal functions such as swallowing (and hence drinking and eating) and talking and reduces patients' psychological well-being. Nearly 90 % of pediatric patients undergoing HSCT are afflicted with OM. In pediatric patients mucositis is reported as one of the most painful and debilitating side effects during cancer treatment.Beyond a significant suffering for the patient it is hence associated with higher costs for health care and increased mortality.
The current scientific situation regarding prevention and treatment of OM has been summarized in Cochrane reports showing limited data on adults and practically missing data on children and adolescents. Concluding guidelines from these reports emphasize the need for well conducted randomized controlled trials (RCT's) to evaluate and refine treatments in order to establish evidence based interventions.
The use of cryotherapy to prevent oral mucositis in patients who are receiving high-dose chemotherapy as a conditioning agent prior to HSCT continue to show evidence in the adult population.
The aim of this study is to compare treatment with cryotherapy (Arm 1)with a standard oral care protocal (Arm 2)
ARM 1 Children are instructed to use chew on ice-chips, ingest ice-cream or ice-water during infusion of chemotherapy as part of the conditioning treatment prior to HSCT. Melted ice should be replaced by new as soon as possible. Children receiving a 24-hour infusion are instructed to use cryotherapy for one hour 4 times a day.
ARM 2 Standard care for prevention and management of oral mucositis
Primary outcome
- Degree and duration of Oral mucositis
Secondary outcomes
- Oral pain
- Opioid use
- Duration of parenteral nutrition
- Weight loss
- Duration of neutropenic fever
- Duration of antibiotic treatment
- Duration of hospitalization
- Emotional and psychological status
- C reactive protein (CRP) and s-albumin correlation to grade of Oral Mucositis
- Conditions
- Oral Mucositis, Pain, Infection, Nutrition Aspect of Cancer
- Being tested
- Cryotherapy
- Keywords
- Oral Mucositis, Children, Cryotherapy, Hematopoietic Stem Cell Transplantation
- Medical subject headings
- Stomatitis, Pain, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
Cryotherapy with ice-chips, ice cream or ice water is given during conditioning treatment with chemotherapy prior to HSCT.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Cryotherapy during conditioning treatment with chemotherapy prior to HSCT Receives: Other: Cryotherapy |
| Control | No intervention | Standard oral Care. No Cryotherapy during conditioning treatment prior to HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucositis grade - WHO Oral Toxicity Scale
WHO-Oral toxicity scale Grade 0 - No mucositis Grade 1 - Erythema and/or soreness Grade 2 - Erythema and/or ulcers. Can eat solid food. Grade 3 - Erythema and/or Ulcers. No solid food but can ingest liquids. Grade 4 - Oral alimentation not possible.
Measured: Daily until engraftment, an expected average of 20 days.
Secondary outcomes (4)
Mucositis grade - Children´s International Mucositis Evaluation Scale (ChiMES)
Daily evaluation by child and parent.
Measured: Daily until engraftment, an expected average of 20 days.
Pain - Childrens Hospital Eastern Ontario Pain Scale (CHEOPS)
Daily assessment by nurse
Measured: Daily until Engraftment an expected average of 20 days.
Mouth Pain
Mouth Pain measured with Numerical Rating scale(NRS)for children >7 years and parents and Facial Pain Scale(FPS) for children < 7 years
Measured: Daily until Engraftment an expected average of 20 days
Emotional and Psychological status
Beck youth inventories for depression and anxiety
Measured: Daily until engraftment, an expected average of 20 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2016
- Study completionOct 2016
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 Oral MucositisStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Childhood Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Gustaf Ljungman, MD, PhD, Study director, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789658
- Sponsor's protocol ID
- UU-OM-01
- Status last verified
- Oct 2016
- First submitted
- 5 Feb 2013
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kamsvag T, Svanberg A, Legert KG, Arvidson J, von Essen L, Mellgren K, Toporski J, Winiarski J, Ljungman G. Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations-a feasibility study and randomized controlled trial. Support Care Cancer. 2020 Oct;28(10):4869-4879. doi: 10.1007/s00520-019-05258-2. Epub 2020 Jan 28.
PubMed 31993753
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Cryotherapy for Prevention and Reduction of Severity of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation.
- ClinicalTrials.gov ID
- NCT01789658
- Acronym / sponsor ID
- UU-OM-01
- Conditions
- Oral Mucositis, Pain, Infection, Nutrition Aspect of Cancer
- Keywords
- Oral Mucositis, Children, Cryotherapy, Hematopoietic Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Childhood Cancer Foundation
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 Feb 2013 (estimated)
- 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.
Oral mucositis (OM) is a common adverse effect of chemotherapy, radiotherapy and conditioning regimens before Hematopoietic Stem Cell Transplantation (HSCT). The aim of this study is to effectiveness of cryotherapy as a prophylactic treatment in children undergoing HSCT.
Detailed description
There is a complex pathobiology behind OM; chemo and radiotherapy affects the mucosa and submucosa causing DNA-strand brakes and generation of reactive oxygen species (ROS). This initiates a cascade of events, among others activation of transcription factors, up-regulation of pro-inflammatory cytokines, and activation of macrophages and proteases leading to tissue injury causing symptoms such as erythema, edema, ulceration, taste perception alterations, and mouth dryness. OM often causes local and systemic infections, fatigue, pain, and difficulties in basal functions such as swallowing (and hence drinking and eating) and talking and reduces patients' psychological well-being. Nearly 90 % of pediatric patients undergoing HSCT are afflicted with OM. In pediatric patients mucositis is reported as one of the most painful and debilitating side effects during cancer treatment.Beyond a significant suffering for the patient it is hence associated with higher costs for health care and increased mortality.
The current scientific situation regarding prevention and treatment of OM has been summarized in Cochrane reports showing limited data on adults and practically missing data on children and adolescents. Concluding guidelines from these reports emphasize the need for well conducted randomized controlled trials (RCT's) to evaluate and refine treatments in order to establish evidence based interventions.
The use of cryotherapy to prevent oral mucositis in patients who are receiving high-dose chemotherapy as a conditioning agent prior to HSCT continue to show evidence in the adult population.
The aim of this study is to compare treatment with cryotherapy (Arm 1)with a standard oral care protocal (Arm 2)
ARM 1 Children are instructed to use chew on ice-chips, ingest ice-cream or ice-water during infusion of chemotherapy as part of the conditioning treatment prior to HSCT. Melted ice should be replaced by new as soon as possible. Children receiving a 24-hour infusion are instructed to use cryotherapy for one hour 4 times a day.
ARM 2 Standard care for prevention and management of oral mucositis
Primary outcome
- Degree and duration of Oral mucositis
Secondary outcomes
- Oral pain
- Opioid use
- Duration of parenteral nutrition
- Weight loss
- Duration of neutropenic fever
- Duration of antibiotic treatment
- Duration of hospitalization
- Emotional and psychological status
- C reactive protein (CRP) and s-albumin correlation to grade of Oral Mucositis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Other: CryotherapyCryotherapy during conditioning treatment with chemotherapy prior to HSCT |
| Control | No intervention | –Standard oral Care. No Cryotherapy during conditioning treatment prior to HSCT |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Age between 4-18 Undergoing Hematopoietic Stem Cell Transplantation in Sweden sufficient knowledge in swedish to understand the protocols -
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 |
|---|---|---|
| CryotherapyCryotherapy with ice-chips, ice cream or ice water is given during conditioning treatment with chemotherapy prior to HSCT. | Other | Cryotherapy |
Primary outcome
Mucositis grade - WHO Oral Toxicity Scale
Time frame: Daily until engraftment, an expected average of 20 days.
WHO-Oral toxicity scale Grade 0 - No mucositis Grade 1 - Erythema and/or soreness Grade 2 - Erythema and/or ulcers. Can eat solid food. Grade 3 - Erythema and/or Ulcers. No solid food but can ingest liquids. Grade 4 - Oral alimentation not possible.
4 secondary outcomes
Mucositis grade - Children´s International Mucositis Evaluation Scale (ChiMES)
Time frame: Daily until engraftment, an expected average of 20 days.
Pain - Childrens Hospital Eastern Ontario Pain Scale (CHEOPS)
Time frame: Daily until Engraftment an expected average of 20 days.
Mouth Pain
Time frame: Daily until Engraftment an expected average of 20 days
Emotional and Psychological status
Time frame: Daily until engraftment, an expected average of 20 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Derived from this study: PubMed 31993753Kamsvag T, Svanberg A, Legert KG, Arvidson J, von Essen L, Mellgren K, Toporski J, Winiarski J, Ljungman G. Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations-a feasibility study and randomized controlled trial. Support Care Cancer. 2020 Oct;28(10):4869-4879. doi: 10.1007/s00520-019-05258-2. Epub 2020 Jan 28.
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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.
Gustaf Ljungman, MD, PhD study director
Uppsala University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Oral Mucositis and Pain, run by Uppsala University at 5 sites in Sweden.
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 1 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: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mucositis grade - WHO Oral Toxicity Scale (time frame: Daily until engraftment, an expected average of 20 days.). 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 NCT01789658, 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 27 Oct 2016.