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. .
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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.
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.
I. Brodsky Associates Outpatient Hematology & Oncology Clinic
Philadelphia, Pennsylvania, United States
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.
Time frame: MAT score is obtained on day 5 following each of the three chemotherapy treatments.
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.
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
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.
Time frame: 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.
Time frame: For the 5 days following each of the two each chemotherapy treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.