Prevention of Unmitigated Chemotherapy-induced Emesis (PUCE Trial)

N/A

Waitlist Available

Led By Michael S Sherman, MD

Research Sponsored by Otolith Labs

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for the 5 days following each of the two chemotherapy treatment.

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. .

Eligible Conditions

CINV
Nausea and Vomiting

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for the 5 days following each of the two chemotherapy treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for the 5 days following each of the two chemotherapy treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and for the 5 days following each of the two chemotherapy treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in MAT (MASCC Antiemesis Tool) score

Secondary study objectives

Change in amount of rescue antiemetics required to control chemotherapy-induced nausea and vomiting

Change in number of episodes of vomiting

Change in population of "Complete responders"

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Otoband efficacy on CINVExperimental Treatment1 Intervention

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.

Group II: Placebo device efficacy on CINVPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Otoband

2021

N/A

~30

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