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Completed

NCT Number: NCT04595838

A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis

This study will compare the use of the Chemo MouthpieceTM device along with best supportive oral care to best supportive oral care alone to rate the effectiveness of Chemo MouthpieceTM in lessening symptoms associated with chemotherapy regimen known to place patients at risk for symptomatic mucositis and, of those, chemotherapy regimens for which ice-based cryotherapy has been demonstrated to have a favorable impact on oral mucositis symptom management. Subjects who are receiving standard chemotherapy regimens will be randomly assigned to receive either study device and oral care ingredients or oral care ingredients only. All subjects will complete daily diaries for the first 14 days of chemotherapy Cycles 1 and 2. Subjects who are assigned to the study device arm will use the device during their chemotherapy infusion in clinic and will continue to use the device at home ,at least twice daily, for the first six (6) days of chemotherapy Cycles 1 and 2. Prior to the first chemotherapy infusion in Cycle 3, all subjects in the study regardless of treatment assignment will have the option of using the Chemo MouthpieceTM for subsequent cycles.

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Key information

Conditions

Oral Mucositis Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chan Soon-Shiong Institute for Medicine, Costa Mesa, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-80 years
  • Planned to receive at least 2 cycles of infused stomatotoxic chemotherapy regimens such as:
  • CMF (cyclophosphamide (Cytoxan), methotrexate, 5-FU)
  • Standard AC+T regimen (doxorubicin (Adriamycin), cyclophosphamide (Cytoxan), Taxane [paclitaxel (Taxol) or docetaxel (Taxotere)]) or any combination of two or more components (e.g., ACT, TAC, TA, AT, AC)
  • ABVD (doxorubicin (Adriamycin), bleomycin, vinblastine, dacarbazine)
  • FOLFIRI (irinotecan, 5-FU, leucovorin)
  • Any other 5-FU-based regimen (excluding FOLFOX)
  • Be willing and able to complete all study-related activities
  • Properly obtained written informed consent

Exclusion criteria

  • Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
  • Concurrent radiotherapy
  • Unable or unwilling to complete study assessments
  • Unable or unwilling to avoid using ice chips
  • Known allergy to silicone
  • Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to randomization
  • Any other clinical or psychiatric condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the protocol
  • Chronic use of opioid analgesics

Treatment and study plan

Chemo Mouthpiece

Device

Frozen tube that fills the oral cavity used during and after chemotherapy to ease and prevent symptoms of oral mucositis

Other names: Oral cryotherapy delivery device

Best Supportive Care only

Other

Standard Oral care for Chemotherapy

Primary outcomes

  1. The incidence of oral mucositis symptomatic events observed during the first cycle of chemotherapy.

    Time frame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)

    The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater.

  2. The incidence of oral mucositis symptomatic events observed during the second cycle of chemotherapy.

    Time frame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)

    The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater.

  3. The incidence of severe oral mucositis symptomatic events observed during the first cycle of chemotherapy.

    Time frame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)

    The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater.

  4. The incidence of severe oral mucositis symptomatic events observed during the second cycle of chemotherapy.

    Time frame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)

    The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater.

Secondary outcomes

  1. Incidence and severity of oral mucositis symptoms per chemotherapy cycle

    Time frame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)

    • The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater.

  2. Incidence and severity of oral mucositis symptoms per chemotherapy cycle

    Time frame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)

    • The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater.

  3. Duration of oral mucositis symptoms

    Time frame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)

    • The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater.

  4. Duration of oral mucositis symptoms

    Time frame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)

    • The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater.

  5. Percent of days the Chemo MouthpieceTM was used

    Time frame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)

    • Device use will be measured on a daily diary completed for at least the first 14 days of each cycle. The diary will also be completed on any additional days that the patient uses the device.

  6. Percent of days the Chemo MouthpieceTM was used

    Time frame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)

    • Device use will be measured on a daily diary completed for at least the first 14 days of each cycle. The diary will also be completed on any additional days that the patient uses the device.

  7. Ease of use of the Chemo MouthpieceTM based on patient-reported Chemo Mouthpiece End of Study Device Assessment

    Time frame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)

    patient-reported Chemo Mouthpiece End of Study Device Assessment

  8. Ease of use of the Chemo MouthpieceTM based on patient-reported Chemo Mouthpiece End of Study Device Assessment

    Time frame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)

    patient-reported Chemo Mouthpiece End of Study Device Assessment

  9. Analgesic use to control mouth pain

    Time frame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)

    Device use will be measured on a daily diary completed for at least the first 14 days of each cycle. The diary will also be completed on any additional days that the patient uses the device.

  10. Analgesic use to control mouth pain

    Time frame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)

    Device use will be measured on a daily diary completed for at least the first 14 days of each cycle. The diary will also be completed on any additional days that the patient uses the device.

Sponsors and collaborators

Lead sponsor

Chemo Mouthpiece

Industry

Registry information

Official study title

A Randomized, Prospective, Multi-center Trial to Assess the Efficacy of a Cryotherapy Device Versus Best Supportive Oral Care in Mitigating Symptoms of Oral Mucositis in Patients Receiving Chemotherapy for the Treatment of Cancer

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2020
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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