Clinical trial · Interventional
Relief Band as an Adjunct to Antiemetic Therapy in Patients Who Receive Mod to Highly Emetogenic Chemotherapy
Randomized Single-Blind Study of Nometex as an Adjunct to Standard Anti-emetics in Ovarian and Advanced Endometrial and Cervical Cancer Patients Who Receive Moderately to Highly Emetogenic Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Did not receive IRB approval from our institution therefore the study was closed.
Summary
Brief summary (as posted)
The primary study hypotheses are that, without increasing doses of breakthrough medications or device intolerance, the Nometex™ device worn for 5-days beginning with the day of chemotherapy administration in women with ovarian or advanced endometrial or cervical cancer will, as an adjunct to standard-of-care anti-emetics, reduce vomiting episodes, and reduce the severity of nausea. The secondary hypotheses are that the Nometex™ device reduces acute (Day 1) emetic episodes, day 1 and days 2-5 severity of nausea, and delayed (days 2-5) emetic episodes without increasing doses of breakthrough medications or device intolerance.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nausea | — | UNRESOLVED | — |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activated Nometex Device | Device | — | UNRESOLVED |
| Unactivated Nometex Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Activated Nometex Device
- description
- Nometex Device that is activated so will be sending electrical pulses to the median nerve which will travel through afferent nerve fibers to the emetic centers of the brain. It is in these areas that the neurotransmitters modulate signals going to the stomach via the Vagus nerve. These electrical signals normalize the stomach rhythms, thereby alleviating nausea and vomiting.
- interventionNames
- Device: Activated Nometex Device
- type
- SHAM_COMPARATOR
- label
- Unactivated Nometex Device
- description
- The Nometex device will not be activated and therefore have no effect on the nausea/vomiting associated with chemotherapy.
- interventionNames
- Device: Unactivated Nometex Device
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with ovarian (including fallopian tube) or advanced endometrial or cervical cancer 2. Chemotherapy-naïve or who have had previous chemotherapy exposure, but who have not yet received the first infusion 3. 18 years of age or older, and can provide cognizant informed consent presenting to the Helen F. Graham Cancer Center 4. ECOG Status of 0-2 5. Standardized Antiemetic Regimen Exclusion Criteria: 1. Pre-existing or at-risk for a peripheral neuropathy in region of device placement 2. Implanted cardiac pace maker 3. Nickel or other metal allergies 4. Previous experience with median nerve/P6 stimulation 5. Receiving concurrent radiation therapy 6. Previous participants of this study will be excluded from future participation in this study.
References
Publications (16)
- BACKGROUNDGriffin AM, Butow PN, Coates AS, Childs AM, Ellis PM, Dunn SM, Tattersall MH. On the receiving end. V: Patient perceptions of the side effects of cancer chemotherapy in 1993. Ann Oncol. 1996 Feb;7(2):189-95. doi: 10.1093/oxfordjournals.annonc.a010548. PMID 8777177
- BACKGROUNDOsoba D, Zee B, Warr D, Latreille J, Kaizer L, Pater J. Effect of postchemotherapy nausea and vomiting on health-related quality of life. The Quality of Life and Symptom Control Committees of the National Cancer Institute of Canada Clinical Trials Group. Support Care Cancer. 1997 Jul;5(4):307-13. doi: 10.1007/s005200050078. PMID 9257427
- BACKGROUNDLindley CM, Hirsch JD, O'Neill CV, Transau MC, Gilbert CS, Osterhaus JT. Quality of life consequences of chemotherapy-induced emesis. Qual Life Res. 1992 Oct;1(5):331-40. doi: 10.1007/BF00434947. PMID 1299465
- BACKGROUNDLaszlo J. Nausea and vomiting as major complications of cancer chemotherapy. Drugs. 1983 Feb;25 Suppl 1:1-7. doi: 10.2165/00003495-198300251-00002. PMID 6840017
- BACKGROUNDCampos D, Pereira JR, Reinhardt RR, Carracedo C, Poli S, Vogel C, Martinez-Cedillo J, Erazo A, Wittreich J, Eriksson LO, Carides AD, Gertz BJ. Prevention of cisplatin-induced emesis by the oral neurokinin-1 antagonist, MK-869, in combination with granisetron and dexamethasone or with dexamethasone alone. J Clin Oncol. 2001 Mar 15;19(6):1759-67. doi: 10.1200/JCO.2001.19.6.1759. PMID 11251007
- BACKGROUNDBirch R, Weaver CH, Carson K, Buckner CD. A randomized trial of once vs twice daily administration of intravenous granisetron with dexamethosone in patients receiving high-dose cyclophosphamide, thiotepa and carboplatin. Bone Marrow Transplant. 1998 Oct;22(7):685-8. doi: 10.1038/sj.bmt.1701412. PMID 9818697
- BACKGROUNDNavari RM, Reinhardt RR, Gralla RJ, Kris MG, Hesketh PJ, Khojasteh A, Kindler H, Grote TH, Pendergrass K, Grunberg SM, Carides AD, Gertz BJ. Reduction of cisplatin-induced emesis by a selective neurokinin-1-receptor antagonist. L-754,030 Antiemetic Trials Group. N Engl J Med. 1999 Jan 21;340(3):190-5. doi: 10.1056/NEJM199901213400304.