Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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.

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 ;


Study Design


Related Conditions & MeSH terms

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

NCT number NCT02326675
Study type Interventional
Source University of Florida
Contact
Status Terminated
Phase N/A
Start date March 2015
Completion date December 2017

See also
  Status Clinical Trial Phase
Completed NCT00766883 - Problem-Solving Education for Caregivers and Patients During Stem Cell Transplant Phase 2
Recruiting NCT06148610 - Evaluation of the Impact of the Use of NewSpringForMe on Transplanted Patients' Quality of Life and Support
Recruiting NCT04690933 - AntiCMV molécules Monitoring in Real-life in Stem Cell Recipients
Completed NCT02564458 - Fitness in Allogeneic Stem Cell Transplantation N/A
Recruiting NCT02543073 - MSC for Treatment of Interstitial Lung Disease After Allo-HSCT Phase 1/Phase 2
Not yet recruiting NCT01714557 - Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation N/A
Completed NCT00701688 - Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Phase 1
Completed NCT00023530 - Blood and Marrow Transplant Clinical Research Network N/A
Recruiting NCT04092309 - Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Patients After Bone Marrow Transplantation N/A
Completed NCT00000603 - Cord Blood Stem Cell Transplantation Study (COBLT) Phase 2
Completed NCT02663622 - Phase II Trial of Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002) Phase 2
Recruiting NCT04937634 - Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation Phase 1
Recruiting NCT04203108 - ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis Phase 4
Completed NCT03654599 - Effects of Digital Stories Intervention on Psychosocial Well-being N/A
Withdrawn NCT03279133 - Ledipasvir/Sofosbuvir Treatment for Hepatitis C in HCT Recipients. Phase 4
Completed NCT05151406 - Myths and Misconceptions About HSCT in a Limited Resource Region N/A
Completed NCT02241005 - Theraworx Bath Wipes Versus Standard Bath Wipes in the Reduction of Vancomycin-Resistant Enterococci N/A
Recruiting NCT03689465 - PTCy-ATG vs ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis Phase 4
Recruiting NCT04868786 - Pharmacokinetics and Pharmacodynamics of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation Phase 1
Recruiting NCT03010579 - Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation Phase 4