Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant
| Status: | Terminated |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 12/7/2018 |
| Start Date: | March 2015 |
| End Date: | December 2017 |
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.
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.
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.
o 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
o 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
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.
o 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
o 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
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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