Prevention of Unmitigated Chemotherapy-induced Emesis

NCT03996863 | Withdrawn DMC FDA Device

• 1 other identifier: OLith10601
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. .

Conditions

Chemotherapy-induced Nausea and Vomiting; Nausea Post Chemotherapy

Keywords

Nausea; Chemotherapy; cisplatin; Emesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in number of episodes of vomiting

  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

  For the 5 days following each of the two chemotherapy treatment.

• Change in population of "Complete responders"

  For the 5 days following each of the two each chemotherapy treatment

Study Arms (2)

Otoband efficacy on CINV

EXPERIMENTAL

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.

Device: Otoband

Placebo device efficacy on CINV

PLACEBO COMPARATOR

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.

Device: Placebo device

Interventions

Otoband DEVICE

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.

Otoband efficacy on CINV

Placebo device 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.

Placebo device efficacy on CINV

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Otolith Labs: lead
• Drexel University College of Medicine: collaborator

Study Sites (1)

I. Brodsky Associates Outpatient Hematology & Oncology Clinic

Philadelphia, Pennsylvania, 19102, United States

Location

Related Publications (3)

• 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.

  PMID: 26768436 BACKGROUND

• 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.

  PMID: 2787840 BACKGROUND

• 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.

  PMID: 26081597 BACKGROUND

MeSH Terms

Conditions

Vomiting; Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael S Sherman, MD

  Drexel University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The sponsor will be randomly assigning the Otoband or placebo device to participants. The investigator will not know which device is assigned.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 25, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)