MedTrace Logo

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

NCT02326675 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-12-05

No results posted yet for this study

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.

Conditions

  • Mucositis
  • Hematopoietic Stem Cell Transplantation
  • Peripheral Blood Stem Cell Transplantation
  • Stomatitis

Interventions

OTHER

Ice

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.

OTHER

Normal Saline Solution

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.

Sponsors & Collaborators

  • University of Florida Health

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Jamie Dees, RN · UF Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02326675 on ClinicalTrials.gov