Studies

Intraoral Scan Test Results

how to treat oral mucositisThe intraoral scan at left (above) shows the subject’s heat distribution before the Chemo Mouthpiece™ was administered. At the right, the scan shows the heat distribution afterward. The light area indicates the highest temperature, the dark shows the lowest.

The device was tested on 12 people in a room maintained at 70 F. The device was held in the mouth for 30 minutes with the oral cavity scanned just prior to insertion, and immediately after it was removed.

The Chemo Mouthpiece™ reduced patients’ oral temperature by an average of 31.2 degrees F, while ice chips only reduce it by an average of 23.2 degrees F. It also cooled the oral cavity more uniformly.

The results are certified by thermographer Julie Conner, CCT.

 

Time/Temperature Log (degrees F)

SessionStart TimeStarting TempEnd TimeEnding Mouth Roof TempEnding Upper Lip TempEnding Bottom Lip tempMeanDifference (Start-Mean)
19:3089.210:0054.971.671.66623.2
210:0093.910:3057.959.269.162.131.9
310:3093.711:0057.660.87564.529.3
411:0095.211:3053.473.874.767.327.9
511:3096.312:005557.761.558.138.2
612:0093.412:3062.264.665.16429.4
71:0095.91:3051.854.969.858.837.1
81:3094.82:0054.957.271.661.233.6
92:0095.72:3066.470.770.769.326.5
102:3093.63:0053.250.563.755.837.7
113:00953:3058.665.767.563.931.1
123:3094.64:0057.666.772.765.729
Averages:94.35762.869.463.131.2
Comparable Cooling with Ice Chips23.2

 

Time/Temperature Log (degrees C)

SessionStart TimeStarting TempEnd TimeEnding Mouth Roof TempEnding Upper Lip TempEnding Bottom Lip tempMeanDifference (Start-Mean)
19:3031.810:0012.722.022.018.912.9
210:0034.410:3014.415.120.616.717.7
310:3034.311:0014.216.023.91816.3
411:0035.711:3012.814.316.414.521.2
511:3035.412:0019.121.521.520.714.7
612:0035.512:3011.012.721.014.920.6
71:0034.11:3016.818.118.417.816.3
81:3035.12:0011.923.223.719.615.5
92:0034.82:3014.219.322.618.716.1
102:3034.93:0012.714.022.016.218.7
113:0034.23:3011.810.317.613.221.0
123:3035.04:0014.818.719.717.717.3
Averages:34.613.8717.120.817.317.4
Comparable Cooling with Ice Chips12.9

 

The following table summarizes the outcomes of various clinical studies on the effect of oral cryotherapy on occurrence of cancer chemotherapy-associated mucositis. The studies include individual clinical studies with small patient cohorts, randomized clinical trials, and meta-analysis of clinical studies. Cancer types in which oral cryotherapy was evaluated span a range of solid tumors including lung, gastrointestinal, other epithelial cancers, as well as haematological cancers. Chemotherapy modalities evaluated include Leucovorin/5-Fluorouracil, Etoposide, Platinol, Mitomycin, Vinblastin, Edatrexate, and Melphalan, in addition to stem cell transplantation in the case of hematologic cancers.

The majority of studies report a convincing evidence level (I, II, or III) supporting the use of oral cryotherapy (in the form of ice chips, flakes, cubes, or balls) to prevent oral mucositis in patients undergoing cancer chemotherapy

A range of treatments to address this problem have been attempted, including pain killing drugs (anesthetics, analgesics), oral coating agents to soothe the condition, anti-inflammatory drugs, antimicrobials to prevent infection and worsening of the condition, and non-drug alternatives including nutritional supplements, laser therapy, and ice therapy. Basic oral care and hygiene is considered an important part of any such treatment

The typical modality of oral ice cryotherapy evaluated involves placing ice in the mouth 5–10 minutes prior to chemotherapy initiation, retaining them throughout the chemotherapy session, and continuing to have ice in the mouth for 15–35 minutes after each session.

The majority of studies report reduction or lack of chemotherapy-induced mouth blisters, pain, and mouth temperature due the use of oral ice cryotherapy.

Cancer Type: Various Solid Tumors

Treatment ModalityReferenceLevel of EvidenceGuideline
Chemotherapy (5-FU bolus i.v)IIRecommendation: that patients receiving bolus 5-FU chemotherapy undergo 30-min oral cryotherapy to prevent oral mucositis

Cancer Type: Hematologic Cancers

Treatment ModalityReferenceLevel of EvidenceGuideline
Haematopoietic stem cell transplantation HSCT) with or without total body irradiation. Chemotherapy(Melphalan)IIISuggestion to use cryotherapy to prevent oral mucositis in patients receiving high-dose melphalan, with or without total body irradiation, as conditioning for HSCT

Cancer Type: Various (excluding Head and Neck)

Treatment ModalityReferenceLevel of EvidenceGuideline
Chemotherapy(Various)IISuggestion to use cryotherapy for mucositis prevention

Cancer Type: Colon Cancer

Treatment ModalityReferenceLevel of EvidenceGuideline
Chemotherapy (Leucovorin/ 5-FU)IIISuggestion to use allopurinol ice balls during chemotherapy

Cancer Type: Various solid tumors (including lung)

Treatment ModalityReferenceLevel of EvidenceGuideline
Chemotherapy (Etoposide, Platinol, Mitomycin, Vinblastin)ISuggestion to place ice cubes in mouth 5 mins before, during, and till end of IV infusion chemotherapy

Cancer Type: Gastrointestinal cancer

Treatment ModalityReferenceLevel of EvidenceGuideline
Chemotherapy(Leucovorin. 5-FU)ISuggestion to place ice cubes in mouth 5 mins before, during, and till end of IV infusion chemotherapy

Cancer Type: Various solid tumors

Treatment ModalityReferenceLevel of EvidenceGuideline
Chemotherapy (5-FU continuous infusion i.v.)IIINo guideline possible

Cancer Type: Various solid tumors

Treatment ModalityReferenceLevel of EvidenceGuideline
Chemotherapy (edatrexate i.v.)(investigational drug)IIINo guideline possible