Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 48
• Participant gender: Both

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. 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: University of Florida Health
• Treatments: Etoposide
• Last Updated: 2016-12-14

Criteria

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.