Chemotherapy-induced Nausea and VomitingPUCENCT03996863
Prevention of Unmitigated Chemotherapy-induced Emesis
A study testing Otoband in people with Chemotherapy-induced Nausea and Vomiting and Nausea Post Chemotherapy, run by Otolith Labs at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting, Nausea Post Chemotherapy
- What is being tested?
- Otoband
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
I. Brodsky Associates Outpatient Hematology & Oncology Clinic
Philadelphia, Pennsylvania, 19102
About this study
Official title: PUCE Study: Prevention of Unmitigated Chemotherapy-induced Emesis
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. .
Read the 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.
- Being tested
- Otoband, Placebo device
- Keywords
- Nausea, Chemotherapy, cisplatin, Emesis
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtobandDevice
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 deviceDevice
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 group | Role | What they receive |
|---|---|---|
| Otoband efficacy on CINV | Experimental | 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. Receives: Device: Otoband |
| Placebo device efficacy on CINV | Placebo comparator | 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. Receives: Device: Placebo device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MAT (MASCC Antiemesis Tool) score
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.
Measured: MAT score is obtained on day 5 following each of the three chemotherapy treatments.
Secondary outcomes (3)
Change in number of episodes of vomiting
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.
Measured: For the 5 days following each of the two chemotherapy infusions, with effective and placebo devices.
Change in amount of rescue antiemetics required to control chemotherapy-induced nausea and vomiting
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.
Measured: For the 5 days following each of the two chemotherapy treatment.
Change in population of "Complete responders"
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.
Measured: For the 5 days following each of the two each chemotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Aug 2019
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Why it stopped: Drexel Oncology was shut down a few days before first patient in.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otolith Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Drexel University College of Medicine
- Responsible party
- Sponsor
- Investigators
- Michael S Sherman, MD, Principal investigator, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996863
- Sponsor's protocol ID
- OLith10601
- Acronym
- PUCE
- Status last verified
- Apr 2021
- First submitted
- 17 Jun 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 26768436Lindley 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. doi: 10.1200/JCO.1989.7.8.1142.
PubMed 2787840Escobar Y, Cajaraville G, Virizuela JA, Alvarez R, Munoz A, Olariaga O, Tames MJ, Muros B, Lecumberri MJ, Feliu J, Martinez P, Adansa JC, Martinez MJ, Lopez R, Blasco A, Gascon 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.
PubMed 26081597
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PUCE Study: Prevention of Unmitigated Chemotherapy-induced Emesis
- ClinicalTrials.gov ID
- NCT03996863
- Acronym / sponsor ID
- PUCE / OLith10601
- Keywords
- Nausea, Chemotherapy, cisplatin, Emesis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Drexel Oncology was shut down a few days before first patient in.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Otolith LabsIndustry (pharma, biotech, devices)
- Collaborators
- Drexel University College of Medicine
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Otoband efficacy on CINV | Experimental | Device: OtobandParticipants 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. |
| Placebo device efficacy on CINV | Placebo comparator | Device: Placebo deviceParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtobandParticipants 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 | Otoband efficacy on CINV |
| Placebo deviceParticipants 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. | Device | Placebo device efficacy on CINV |
Primary outcome
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.
3 secondary outcomes
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.
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.
Change in population of "Complete responders"
Time frame: For the 5 days following each of the two each chemotherapy treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 26768436Kottschade 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.
- Background: PubMed 2787840Lindley 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. doi: 10.1200/JCO.1989.7.8.1142.
- Background: PubMed 26081597Escobar Y, Cajaraville G, Virizuela JA, Alvarez R, Munoz A, Olariaga O, Tames MJ, Muros B, Lecumberri MJ, Feliu J, Martinez P, Adansa JC, Martinez MJ, Lopez R, Blasco A, Gascon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Sherman, MD principal investigator
Drexel University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otoband in people with Chemotherapy-induced Nausea and Vomiting and Nausea Post Chemotherapy, run by Otolith Labs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MAT (MASCC Antiemesis Tool) score (time frame: MAT score is obtained on day 5 following each of the three chemotherapy treatments.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03996863, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.