Prevention of Unmitigated Chemotherapy-induced Emesis

Not Applicable

Withdrawn

• Conditions: Chemotherapy-induced Nausea and Vomiting; Nausea Post Chemotherapy
• Interventions: Device: Otoband; Device: Placebo device

• Registration Number: NCT03996863
• Lead Sponsor: Otolith Labs

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 Timeline

• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-25
• Study Start: 2019-08-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-23
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Otoband efficacy on CINV	Otoband	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.
Placebo device efficacy on CINV	Placebo device	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.

Primary Outcome Measures

Name	Time	Method
Change in MAT (MASCC Antiemesis Tool) score	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

Name	Time	Method
Change in number of episodes of vomiting	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	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"	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.

Trial Locations

Locations (1)

I. Brodsky Associates Outpatient Hematology & Oncology Clinic; 🇺🇸 Philadelphia, Pennsylvania, United States