Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant
Stopped early · Not applicable
Conditions studied: Mucositis, Hematopoietic Stem Cell Transplantation, Peripheral Blood Stem Cell Transplantation, Stomatitis
In brief
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.
Key facts
- Study ID
- NCT02326675
- Run by
- University of Florida
- People needed
- 29
- Starts
- 2015-03-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2018-12-05
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- UF Health Shands Cancer Hopsital — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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