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出境医 / 临床实验 / Prevention of Unmitigated Chemotherapy-induced Emesis (PUCE)

Prevention of Unmitigated Chemotherapy-induced Emesis (PUCE)

Study Description
Brief Summary:
Chemotherapy-induced nausea and vomiting (CINV) remains a major obstacle to patient care and continues to decrease quality of life. Despite the addition of medications and antiemetic regimens, doctors' ability to control CINV is still inadequate: even moderately-emetogenic chemotherapy regimens cause roughly 20% of patients to have vomiting and over 40% to experience significant nausea. In this study, the investigators test a transcranial vibrating system that has shown great promise at reducing nausea and vomiting. .

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Nausea and Vomiting Nausea Post Chemotherapy Device: Otoband Device: Placebo device Not Applicable

Detailed Description:

Chemotherapy-induced nausea and vomiting (CINV) remains a major obstacle to cancer patient care despite numerous medications being available to prevent and treat CINV.

CINV decreases quality of life in roughly one third of patients receiving highly emetogenic chemotherapy. In addition, roughly half to two thirds of all patients receiving chemotherapy require rescue anti-emetic medications despite being given guideline-based prophylactic anti-emetics.The anti-emesis armamentarium continues to grow with new medications, including olanzapine and fosaprepitant, being studied in recent years. However, despite the addition of these medications and guideline-based antiemetic regimens, the ability to control CINV is still inadequate as even moderately-emetogenic chemotherapy regimens cause roughly 20% of patients to have vomiting and over 40% to experience significant nausea.

In this study, the investigators aim to test a new transcranial vibrating system that has shown promise in phase I studies for treating dizziness, motion sickness and nausea.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Patients who qualify for the study based on their response to the first round of chemotherapy will be randomly assigned to one of two groups for their second and third rounds of chemotherapy.

Half of the patients will be given a device set at working parameters believed to significantly mitigate nausea for their second round, and a placebo device for the third round of chemotherapy. The second half of the patients will receive the placebo device for the second round and the effective device for the third round.
Masking: Double (Participant, Investigator)
Masking Description: The sponsor will be randomly assigning the Otoband or placebo device to participants. The investigator will not know which device is assigned.
Primary Purpose: Treatment
Official Title: PUCE Study: Prevention of Unmitigated Chemotherapy-induced Emesis
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Otoband efficacy on CINV

Participants will wear the Otoband during infusion following chemotherapy treatments, placed against the skin, on the flat part of the right mastoid bone.

The Otoband will be able to function maximum 16 hours per day. Study participants will be instructed to use the device for 30 minutes in the morning, and then as needed for symptoms while at home for four days. Once the OtoBand is applied and turned on they are expected to wear it continually for up to 30 minutes. Subjects can stop the OtoBand 5 minutes after cessation of nausea but will be asked to resume stimulation if the nausea recurs within 30 minutes. The participant will be asked to fill out the MASCC Antiemesis Tool questionnaire at 24 hours post infusion and again at day 5 post infusion. Participants will also be asked to fill out an OtoBand Use Questionnaire daily for the four days following their chemotherapy infusion.

 Device: Otoband
Participants during infusion following chemotherapy will wear the Otoband set at normal power (effective) for four days following treatment and nausea outcomes will be recorded by questionnaire or by the investigator during site visits.
Placebo Comparator: Placebo device efficacy on CINV

Participants will wear the placebo device during infusion following chemotherapy treatments, placed against the skin, on the flat part of the right mastoid bone.

The placebo device will be able to function maximum 16 hours per day. Study participants will be instructed to use the device for 30 minutes in the morning, and then as needed for symptoms while at home for four days. Once the device is applied and turned on they are expected to wear it continually for up to 30 minutes. Subjects can stop the device 5 minutes after cessation of nausea but will be asked to resume stimulation if the nausea recurs within 30 minutes. The participant will be asked to fill out the MASCC Antiemesis Tool questionnaire at 24 hours post infusion and again at day 5 post infusion. Participants will also be asked to fill out an OtoBand Use Questionnaire daily for the four days following their chemotherapy infusion.

 Device: Placebo device
Participants during infusion following chemotherapy will wear the placebo device set at low power (6 decibels lower than normal power, ineffective power) for four days following treatment and nausea outcomes will be recorded by questionnaire or by the investigator during site visits.
Outcome Measures
Primary Outcome Measures :
  1. Change in MAT (MASCC Antiemesis Tool) score [ Time Frame: MAT score is obtained on day 5 following each of the three chemotherapy treatments. ]

    Potential subjects will be screened for eligibility based on their responses to the (standard of care) questionnaire developed by the "Multinational Association for Supportive Care in Cancer" and called the MAT (Multinational Antiemesis Tool). MAT scores range from 0 (no issue) to 10 (most severe).

    Any difference in severity of nausea as measured by MAT score between active and placebo phases, and compared to the scores obtained in the pre-trial round of chemotherapy, will be analyzed.



Secondary Outcome Measures :
  1. Change in number of episodes of vomiting [ Time Frame: For the 5 days following each of the two chemotherapy infusions, with effective and placebo devices. ]
    The investigator will quantify any difference in the number of episodes of vomiting experienced because of chemotherapy-induced nausea and vomiting (CINV) between effective and placebo phases, and compare to the number of episodes that happened during the previous pre-trial chemotherapy session.

  2. Change in amount of rescue antiemetics required to control chemotherapy-induced nausea and vomiting [ Time Frame: For the 5 days following each of the two chemotherapy treatment. ]
    The investigator will quantify any difference in the amount of rescue antiemetics the patient chooses to control chemotherapy-induced nausea and vomiting (CINV) between effective and placebo phases, and compare to the amounts taken during the previous pre-trial chemotherapy session.

  3. Change in population of "Complete responders" [ Time Frame: For the 5 days following each of the two each chemotherapy treatment ]
    The investigator will quantify any difference in number of participants who are Complete Responders, as defined by a nausea severity scale on the MAT < 3, no vomiting, and no use of rescue antiemetics for the complete 4 days following chemotherapy infusion, between acute and placebo phases.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject currently receiving chemotherapy known to be emetogenic (i.e subject has already received one round of chemotherapy)
  • MASCC Antiemesis Tool score of > 6 on the nausea severity scale and/or
  • One or more episodes of vomiting anytime in the 4 days following receipt of chemotherapy and/or
  • The need for three or more uses of rescue antiemetic medications within 4 days of chemotherapy during previous round.

Exclusion Criteria:

  • Pregnant women
  • Individuals unable to provide informed consent
  • Any preexisting condition causing significant nausea or vomiting, or causing reaction to the bone conduction system (e.g. superior canal dehiscence)
  • Prisoners
Contacts and Locations

Locations
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United States, Pennsylvania
I. Brodsky Associates Outpatient Hematology & Oncology Clinic
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Otolith Labs
Drexel University College of Medicine
Investigators
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Principal Investigator: Michael S Sherman, MD Drexel University College of Medicine
Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date April 27, 2021
Actual Study Start Date  ICMJE August 1, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019) 		Change in MAT (MASCC Antiemesis Tool) score [ Time Frame: MAT score is obtained on day 5 following each of the three chemotherapy treatments. ]
Potential subjects will be screened for eligibility based on their responses to the (standard of care) questionnaire developed by the "Multinational Association for Supportive Care in Cancer" and called the MAT (Multinational Antiemesis Tool). MAT scores range from 0 (no issue) to 10 (most severe). Any difference in severity of nausea as measured by MAT score between active and placebo phases, and compared to the scores obtained in the pre-trial round of chemotherapy, will be analyzed.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Change in number of episodes of vomiting [ Time Frame: For the 5 days following each of the two chemotherapy infusions, with effective and placebo devices. ]
    The investigator will quantify any difference in the number of episodes of vomiting experienced because of chemotherapy-induced nausea and vomiting (CINV) between effective and placebo phases, and compare to the number of episodes that happened during the previous pre-trial chemotherapy session.
  • Change in amount of rescue antiemetics required to control chemotherapy-induced nausea and vomiting [ Time Frame: For the 5 days following each of the two chemotherapy treatment. ]
    The investigator will quantify any difference in the amount of rescue antiemetics the patient chooses to control chemotherapy-induced nausea and vomiting (CINV) between effective and placebo phases, and compare to the amounts taken during the previous pre-trial chemotherapy session.
  • Change in population of "Complete responders" [ Time Frame: For the 5 days following each of the two each chemotherapy treatment ]
    The investigator will quantify any difference in number of participants who are Complete Responders, as defined by a nausea severity scale on the MAT < 3, no vomiting, and no use of rescue antiemetics for the complete 4 days following chemotherapy infusion, between acute and placebo phases.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Unmitigated Chemotherapy-induced Emesis
Official Title  ICMJE PUCE Study: Prevention of Unmitigated Chemotherapy-induced Emesis
Brief Summary Chemotherapy-induced nausea and vomiting (CINV) remains a major obstacle to patient care and continues to decrease quality of life. Despite the addition of medications and antiemetic regimens, doctors' ability to control CINV is still inadequate: even moderately-emetogenic chemotherapy regimens cause roughly 20% of patients to have vomiting and over 40% to experience significant nausea. In this study, the investigators test a transcranial vibrating system that has shown great promise at reducing nausea and vomiting. .
Detailed Description

Chemotherapy-induced nausea and vomiting (CINV) remains a major obstacle to cancer patient care despite numerous medications being available to prevent and treat CINV.

CINV decreases quality of life in roughly one third of patients receiving highly emetogenic chemotherapy. In addition, roughly half to two thirds of all patients receiving chemotherapy require rescue anti-emetic medications despite being given guideline-based prophylactic anti-emetics.The anti-emesis armamentarium continues to grow with new medications, including olanzapine and fosaprepitant, being studied in recent years. However, despite the addition of these medications and guideline-based antiemetic regimens, the ability to control CINV is still inadequate as even moderately-emetogenic chemotherapy regimens cause roughly 20% of patients to have vomiting and over 40% to experience significant nausea.

In this study, the investigators aim to test a new transcranial vibrating system that has shown promise in phase I studies for treating dizziness, motion sickness and nausea.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Patients who qualify for the study based on their response to the first round of chemotherapy will be randomly assigned to one of two groups for their second and third rounds of chemotherapy.

Half of the patients will be given a device set at working parameters believed to significantly mitigate nausea for their second round, and a placebo device for the third round of chemotherapy. The second half of the patients will receive the placebo device for the second round and the effective device for the third round.

Masking: Double (Participant, Investigator)
Masking Description:
The sponsor will be randomly assigning the Otoband or placebo device to participants. The investigator will not know which device is assigned.
Primary Purpose: Treatment
Condition  ICMJE
  • Chemotherapy-induced Nausea and Vomiting
  • Nausea Post Chemotherapy
Intervention  ICMJE
  • Device: Otoband
    Participants during infusion following chemotherapy will wear the Otoband set at normal power (effective) for four days following treatment and nausea outcomes will be recorded by questionnaire or by the investigator during site visits.
  • Device: Placebo device
    Participants during infusion following chemotherapy will wear the placebo device set at low power (6 decibels lower than normal power, ineffective power) for four days following treatment and nausea outcomes will be recorded by questionnaire or by the investigator during site visits.
Study Arms  ICMJE
  • Experimental: Otoband efficacy on CINV

    Participants will wear the Otoband during infusion following chemotherapy treatments, placed against the skin, on the flat part of the right mastoid bone.

    The Otoband will be able to function maximum 16 hours per day. Study participants will be instructed to use the device for 30 minutes in the morning, and then as needed for symptoms while at home for four days. Once the OtoBand is applied and turned on they are expected to wear it continually for up to 30 minutes. Subjects can stop the OtoBand 5 minutes after cessation of nausea but will be asked to resume stimulation if the nausea recurs within 30 minutes. The participant will be asked to fill out the MASCC Antiemesis Tool questionnaire at 24 hours post infusion and again at day 5 post infusion. Participants will also be asked to fill out an OtoBand Use Questionnaire daily for the four days following their chemotherapy infusion.

    Intervention: Device: Otoband
  • Placebo Comparator: Placebo device efficacy on CINV

    Participants will wear the placebo device during infusion following chemotherapy treatments, placed against the skin, on the flat part of the right mastoid bone.

    The placebo device will be able to function maximum 16 hours per day. Study participants will be instructed to use the device for 30 minutes in the morning, and then as needed for symptoms while at home for four days. Once the device is applied and turned on they are expected to wear it continually for up to 30 minutes. Subjects can stop the device 5 minutes after cessation of nausea but will be asked to resume stimulation if the nausea recurs within 30 minutes. The participant will be asked to fill out the MASCC Antiemesis Tool questionnaire at 24 hours post infusion and again at day 5 post infusion. Participants will also be asked to fill out an OtoBand Use Questionnaire daily for the four days following their chemotherapy infusion.

    Intervention: Device: Placebo device
Publications *
  • Kottschade L, Novotny P, Lyss A, Mazurczak M, Loprinzi C, Barton D. Chemotherapy-induced nausea and vomiting: incidence and characteristics of persistent symptoms and future directions NCCTG N08C3 (Alliance). Support Care Cancer. 2016 Jun;24(6):2661-7. doi: 10.1007/s00520-016-3080-y. Epub 2016 Jan 15.
  • Lindley CM, Bernard S, Fields SM. Incidence and duration of chemotherapy-induced nausea and vomiting in the outpatient oncology population. J Clin Oncol. 1989 Aug;7(8):1142-9.
  • Escobar Y, Cajaraville G, Virizuela JA, Álvarez R, Muñoz A, Olariaga O, Tamés MJ, Muros B, Lecumberri MJ, Feliu J, Martínez P, Adansa JC, Martínez MJ, López R, Blasco A, Gascón P, Calvo V, Luna P, Montalar J, Del Barrio P, Tornamira MV. Incidence of chemotherapy-induced nausea and vomiting with moderately emetogenic chemotherapy: ADVICE (Actual Data of Vomiting Incidence by Chemotherapy Evaluation) study. Support Care Cancer. 2015 Sep;23(9):2833-40. doi: 10.1007/s00520-015-2809-3. Epub 2015 Jun 17. Erratum in: Support Care Cancer. 2015 Sep;23(9):2841.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 23, 2021) 		0
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2019) 		40
Actual Study Completion Date  ICMJE August 1, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject currently receiving chemotherapy known to be emetogenic (i.e subject has already received one round of chemotherapy)
  • MASCC Antiemesis Tool score of > 6 on the nausea severity scale and/or
  • One or more episodes of vomiting anytime in the 4 days following receipt of chemotherapy and/or
  • The need for three or more uses of rescue antiemetic medications within 4 days of chemotherapy during previous round.

Exclusion Criteria:

  • Pregnant women
  • Individuals unable to provide informed consent
  • Any preexisting condition causing significant nausea or vomiting, or causing reaction to the bone conduction system (e.g. superior canal dehiscence)
  • Prisoners
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03996863
Other Study ID Numbers  ICMJE OLith10601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Otolith Labs
Study Sponsor  ICMJE Otolith Labs
Collaborators  ICMJE Drexel University College of Medicine
Investigators  ICMJE
Principal Investigator: Michael S Sherman, MD Drexel University College of Medicine
PRS Account Otolith Labs
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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