MucositisNCT02326675
Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant
A study testing Ice and Normal Saline Solution in people with Mucositis and Hematopoietic Stem Cell Transplantation, run by University of Florida at 1 site in United States.
Trial summary
Oral mucositis is a common complication of cancer therapy. Mucositis results from damage to the mucosal epithelium after delivery of chemotherapy or radiation treatments designed to treat the cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Mucositis, Hematopoietic Stem Cell Transplantation, Peripheral Blood Stem Cell Transplantation
- What is being tested?
- Ice and Normal Saline Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2017
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects age 18 year old or older who are eligible candidates for myeloablative autologous stem cell transplantation (ASCT).
- Subjects receiving etoposide as part of their conditioning regimen with a planned total dose of ≥ 30 mg/kg.
Who cannot join
- Subjects with prior radiation to head \& neck region.
- Subjects with known oropharynx involvement with their malignancy.
- Subjects with a history of non-compliance or who lack capacity to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Shands Cancer Hopsital
Gainesville, Florida, 32608
About this study
Official title: Randomized Controlled, Open-Label Study on the Use of Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant Patients
Oral mucositis is a common complication of cancer therapy. Mucositis results from damage to the mucosal epithelium after delivery of chemotherapy or radiation treatments designed to treat the cancer. A number of treatment factors have been shown to influence the incidence and severity of mucositis, including chemotherapy type and dosage. High-dose chemotherapy before stem cell transplantation can cause severe oral mucositis and is often the side effect that patients find the most difficult to endure. Cryotherapy, keeping ice chips in the mouth during chemotherapy infusion, has been shown to prevent or alleviate mucositis caused by high-dose melphalan alone or given in combinations used in pre-transplant conditioning. One other drug notorious for causing severe mucositis is etoposide (VP-16). The specific aims of the study are: 1) to assess tolerability of cryotherapy given during chemotherapy administration; 2) to determine the efficacy of cryotherapy in reducing etoposide-induced mucositis.
Read the detailed description
As a participant the following will happen:
There will be a random assignment (much like the flip of a coin) to one of two study groups:
- Group A: Standard mouth care plus cryotherapy, or
- Group B: Standard mouth care.
Standard Mouth Care plus Cryotherapy (Group A)
Will receive the standard mouth care plus Cryotherapy and will consist of:
- Mouth care 3 times daily with a soft-bristle toothbrush or foam toothbrush
- Cryotherapy - beginning 15 minutes before etoposide chemotherapy starts, the consumption of ice chips and/or other very cold and frozen foods (popsicles, Italian Ice etc.) continuously for 30 minutes.
- Short (1 to 3 minutes maximum) breaks over the course of the 30 minute period as long as at least 15 minutes are spent actively engaged in the cryotherapy
- Saline "swish and spit" mouth rinses - you will be asked to rinse your mouth with saline for approximately 30 seconds before spitting out the saline into the sink or basin
- You will be asked to do this 3 times over 15 minutes following each 30 minute period of cryotherapy
- The cycle of 30 minutes of cryotherapy followed by 15 minutes of saline mouth rinses will be repeated until 30 minutes after the etoposide infusion (approximately 3 cycles for a typical 120 minute infusion).
Standard Mouth Care (Group B)
Randomization to the Standard Mouth Care group will consist of:
- Mouth care 3 times daily with a soft-bristle toothbrush or foam toothbrush
- Saline "swish and spit" mouth rinse - rinse the mouth with saline for approximately 30 seconds before spitting out the saline into the sink or basin
- At the beginning of each etoposide infusion, perform three 30-second saline rinses over 15 minutes followed by a 30-minute break from the rinses
- The cycle of 15-minute saline mouth rinses followed by 30-minute break periods will be repeated until 30 minutes after the etoposide infusion (approximately 3 cycles for a typical 120 minute infusion).
The standard mouth care group, will not be permitted to eat ice chips or consume frozen foods during the times these times.
All groups will have the following interventions and assessments performed:
- Mouth Care Diary - the time and type of mouth care and/or cryotherapy
- Mucositis Assessments - pain levels, appetite, ability to swallow liquids and/or food
- Conditions
- Mucositis, Hematopoietic Stem Cell Transplantation, Peripheral Blood Stem Cell Transplantation, Stomatitis
- Being tested
- Ice, Normal Saline Solution
- Keywords
- Etoposide, Cryotherapy
- Medical subject headings
- Mucositis, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IceOther
Also called Cryotherapy,Ice Chips
This group will receive cryotherapy, saline rinses, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators as part of their participation.
Normal Saline SolutionOther
This group will receive saline rinses, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators as part of their participation.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy Group (Group A) | Active comparator | Subjects in the intervention group will receive both standard oral care and cryotherapy. During the 30 minute cryotherapy periods, subjects will eat ice chips, and/or consume very cold or frozen foods. Cryotherapy will begin 15 minutes prior to the start time of each etoposide infusion. After 30 minutes of cryotherapy, subjects will begin the saline rinses. The subject should perform 3 saline rinses over 15 minutes. After 15 minutes of saline rinses, the 30-minute cryotherapy / 15-minute saline rinse cycles will be repeated until 30 min after completion of etoposide infusion (approximately 150 minutes). In addition, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators. Receives: Other: Ice |
| Standard Oral Care Group (Group B) | Active comparator | Subjects in the control group will receive standard oral care only. At the beginning of each etoposide infusion, the subject will begin the saline rinses. The subject will perform 3 saline rinses over 15 minutes followed by 30 minutes of rest (no rinses). The 15-minute saline rinse / 30-minute rest cycles will be repeated until 30 minutes after the completion of the etoposide infusion (approximately 150 minutes). In addition, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators. Receives: Other: Normal Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that tolerate cryotherapy during each etoposide infusion
Measured: Up to seven days prior to stem cell transplant.
Time to onset, severity and duration of mucositis following etoposide administration
Measured: Participants will be followed starting on Day +1 post-transplant until they are discharged from the hospital, an expected average of 3-4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Interim analysis: results of the analysis showed no significant difference between the two study groups
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida Health
- Responsible party
- Sponsor
- Investigators
- Jamie Dees, RN, Principal investigator, UF Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326675
- Sponsor's protocol ID
- IRB201400628
- Status last verified
- Dec 2018
- First submitted
- 12 Dec 2014
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled, Open-Label Study on the Use of Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT02326675
- Acronym / sponsor ID
- IRB201400628
- Conditions
- Mucositis, Hematopoietic Stem Cell Transplantation, Peripheral Blood Stem Cell Transplantation, Stomatitis
- Keywords
- Etoposide, Cryotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis: results of the analysis showed no significant difference between the two study groups
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of Florida Health
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Dec 2014 (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 is a common complication of cancer therapy. Mucositis results from damage to the mucosal epithelium after delivery of chemotherapy or radiation treatments designed to treat the cancer. A number of treatment factors have been shown to influence the incidence and severity of mucositis, including chemotherapy type and dosage. High-dose chemotherapy before stem cell transplantation can cause severe oral mucositis and is often the side effect that patients find the most difficult to endure. Cryotherapy, keeping ice chips in the mouth during chemotherapy infusion, has been shown to prevent or alleviate mucositis caused by high-dose melphalan alone or given in combinations used in pre-transplant conditioning. One other drug notorious for causing severe mucositis is etoposide (VP-16). The specific aims of the study are: 1) to assess tolerability of cryotherapy given during chemotherapy administration; 2) to determine the efficacy of cryotherapy in reducing etoposide-induced mucositis.
Detailed description
As a participant the following will happen:
There will be a random assignment (much like the flip of a coin) to one of two study groups:
- Group A: Standard mouth care plus cryotherapy, or
- Group B: Standard mouth care.
Standard Mouth Care plus Cryotherapy (Group A)
Will receive the standard mouth care plus Cryotherapy and will consist of:
- Mouth care 3 times daily with a soft-bristle toothbrush or foam toothbrush
- Cryotherapy - beginning 15 minutes before etoposide chemotherapy starts, the consumption of ice chips and/or other very cold and frozen foods (popsicles, Italian Ice etc.) continuously for 30 minutes.
- Short (1 to 3 minutes maximum) breaks over the course of the 30 minute period as long as at least 15 minutes are spent actively engaged in the cryotherapy
- Saline "swish and spit" mouth rinses - you will be asked to rinse your mouth with saline for approximately 30 seconds before spitting out the saline into the sink or basin
- You will be asked to do this 3 times over 15 minutes following each 30 minute period of cryotherapy
- The cycle of 30 minutes of cryotherapy followed by 15 minutes of saline mouth rinses will be repeated until 30 minutes after the etoposide infusion (approximately 3 cycles for a typical 120 minute infusion).
Standard Mouth Care (Group B)
Randomization to the Standard Mouth Care group will consist of:
- Mouth care 3 times daily with a soft-bristle toothbrush or foam toothbrush
- Saline "swish and spit" mouth rinse - rinse the mouth with saline for approximately 30 seconds before spitting out the saline into the sink or basin
- At the beginning of each etoposide infusion, perform three 30-second saline rinses over 15 minutes followed by a 30-minute break from the rinses
- The cycle of 15-minute saline mouth rinses followed by 30-minute break periods will be repeated until 30 minutes after the etoposide infusion (approximately 3 cycles for a typical 120 minute infusion).
The standard mouth care group, will not be permitted to eat ice chips or consume frozen foods during the times these times.
All groups will have the following interventions and assessments performed:
- Mouth Care Diary - the time and type of mouth care and/or cryotherapy
- Mucositis Assessments - pain levels, appetite, ability to swallow liquids and/or food
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy Group (Group A) | Active comparator | Other: IceSubjects in the intervention group will receive both standard oral care and cryotherapy. During the 30 minute cryotherapy periods, subjects will eat ice chips, and/or consume very cold or frozen foods. Cryotherapy will begin 15 minutes prior to the start time of each etoposide infusion. After 30 minutes of cryotherapy, subjects will begin the saline rinses. The subject should perform 3 saline rinses over 15 minutes. After 15 minutes of saline rinses, the 30-minute cryotherapy / 15-minute saline rinse cycles will be repeated until 30 min after completion of etoposide infusion (approximately 150 minutes). In addition, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators. |
| Standard Oral Care Group (Group B) | Active comparator | Other: Normal Saline SolutionSubjects in the control group will receive standard oral care only. At the beginning of each etoposide infusion, the subject will begin the saline rinses. The subject will perform 3 saline rinses over 15 minutes followed by 30 minutes of rest (no rinses). The 15-minute saline rinse / 30-minute rest cycles will be repeated until 30 minutes after the completion of the etoposide infusion (approximately 150 minutes). In addition, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects age 18 year old or older who are eligible candidates for myeloablative autologous stem cell transplantation (ASCT).
- Subjects receiving etoposide as part of their conditioning regimen with a planned total dose of ≥ 30 mg/kg.
Key exclusion criteria (3 listed)
- Subjects with prior radiation to head \& neck region.
- Subjects with known oropharynx involvement with their malignancy.
- Subjects with a history of non-compliance or who lack capacity to give informed consent.
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 |
|---|---|---|
| IceAlso: Cryotherapy,Ice ChipsThis group will receive cryotherapy, saline rinses, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators as part of their participation. | Other | Cryotherapy Group (Group A) |
| Normal Saline SolutionThis group will receive saline rinses, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators as part of their participation. | Other | Standard Oral Care Group (Group B) |
Primary outcome
Number of participants that tolerate cryotherapy during each etoposide infusion
Time frame: Up to seven days prior to stem cell transplant.
Time to onset, severity and duration of mucositis following etoposide administration
Time frame: Participants will be followed starting on Day +1 post-transplant until they are discharged from the hospital, an expected average of 3-4 weeks.
Results and safety
The study was stopped early (reason given: Interim analysis: results of the analysis showed no significant difference between the two study groups). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
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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.
Jamie Dees, RN principal investigator
UF Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice and Normal Saline Solution in people with Mucositis and Hematopoietic Stem Cell Transplantation, run by University of Florida 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Dec 2018. 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.
Are results available for this study?
The study was stopped early (reason given: Interim analysis: results of the analysis showed no significant difference between the two study groups). 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?
Number of participants that tolerate cryotherapy during each etoposide infusion (time frame: Up to seven days prior to stem cell transplant.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2018.