Prevention of Unmitigated Chemotherapy-induced Emesis

Chemotherapy-induced Nausea and Vomiting Clinical Trial

— PUCE  

Official title:

PUCE Study: Prevention of Unmitigated Chemotherapy-induced Emesis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03996863
• Other study ID #: OLith10601
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: April 2021
• Source: Otolith Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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. .

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Nausea Post Chemotherapy
• Vomiting

Intervention

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 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.

Locations

Country	Name	City	State
United States	I. Brodsky Associates Outpatient Hematology & Oncology Clinic	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Otolith Labs	Drexel University College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	MAT score is obtained on day 5 following each of the three chemotherapy treatments.
Secondary	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.	For the 5 days following each of the two chemotherapy infusions, with effective and placebo devices.
Secondary	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.	For the 5 days following each of the two chemotherapy treatment.
Secondary	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.	For the 5 days following each of the two each chemotherapy treatment