Clinical trial NCT03996863: Prevention of Unmitigated Chemotherapy-induced Emesis
Official title: PUCE Study: Prevention of Unmitigated Chemotherapy-induced Emesis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Nausea Post Chemotherapy
Keywords: Nausea
Chemotherapy
cisplatin
Emesis
Lead sponsor: Otolith Labs
Sponsor class: INDUSTRY
Collaborators: name: Drexel University College of Medicine
First posted: 2019-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in MAT (MASCC Antiemesis Tool) score
timeFrame: MAT score is obtained on day 5 following each of the three chemotherapy treatments.
Secondary outcomes:
measure: Change in number of episodes of vomiting
timeFrame: For the 5 days following each of the two chemotherapy infusions, with effective and placebo devices.
measure: Change in amount of rescue antiemetics required to control chemotherapy-induced nausea and vomiting
timeFrame: For the 5 days following each of the two chemotherapy treatment.
measure: Change in population of "Complete responders"
timeFrame: For the 5 days following each of the two each chemotherapy treatment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: I. Brodsky Associates Outpatient Hematology & Oncology Clinic
state: Pennsylvania
Study officials:
affiliation: Drexel University College of Medicine
name: Michael S Sherman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1200/JCO.1989.7.8.1142.
citation: Escobar 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.