Relief Band as an Adjunct to Antiemetic Therapy in Patients Who Receive Mod to Highly Emetogenic Chemotherapy

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01980160
• Other study ID #: NMT-Nometex
• Status: Withdrawn
• Phase: N/A
• First received: October 14, 2013
• Last updated: September 30, 2015
• Start date: November 2013
• Est. completion date: January 2016

Study information

• Verified date: September 2015
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Device:
• Activated Nometex Device
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.
• Unactivated Nometex Device

Locations

Country	Name	City	State
United States	Helen F. Graham Cancer Center	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Christiana Care Health Services	Neurowave Medical Technologies

Country where clinical trial is conducted

United States, 

References & Publications (16)

Birch 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. — View Citation

Campos 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. — View Citation

Gralla RJ, Osoba D, Kris MG, Kirkbride P, Hesketh PJ, Chinnery LW, Clark-Snow R, Gill DP, Groshen S, Grunberg S, Koeller JM, Morrow GR, Perez EA, Silber JH, Pfister DG. Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. American Society of Clinical Oncology. J Clin Oncol. 1999 Sep;17(9):2971-94. Erratum in: J Clin Oncol 2000 Aug;18(16):3064. J Clin Oncol 1999 Dec;17(12):3860. — View Citation

Griffin 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. — View Citation

Herrington JD, Kwan P, Young RR, Lagow E, Lagrone L, Riggs MW. Randomized, multicenter comparison of oral granisetron and oral ondansetron for emetogenic chemotherapy. Pharmacotherapy. 2000 Nov;20(11):1318-23. — View Citation

Laszlo J. Nausea and vomiting as major complications of cancer chemotherapy. Drugs. 1983 Feb;25 Suppl 1:1-7. — View Citation

Lindley 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. — View Citation

Navari 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. — View Citation

Osoba 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. — View Citation

Osowski CL, Dix SP, Lynn M, Davidson T, Cohen L, Miyahara T, Sexauer MC, Joyce R, Yeager A, Wingard JR. An open-label dose comparison study of ondansetron for the prevention of emesis associated with chemotherapy prior to bone marrow transplantation. Support Care Cancer. 1998 Nov;6(6):511-7. — View Citation

Oyama H, Kaneda M, Katsumata N, Akechi T, Ohsuga M. Using the bedside wellness system during chemotherapy decreases fatigue and emesis in cancer patients. J Med Syst. 2000 Jun;24(3):173-82. — View Citation

Schwartzberg LS. Chemotherapy-induced nausea and vomiting: which antiemetic for which therapy? Oncology (Williston Park). 2007 Jul;21(8):946-53; discussion 954, 959, 962 passim. Review. — View Citation

Shen J, Wenger N, Glaspy J, Hays RD, Albert PS, Choi C, Shekelle PG. Electroacupuncture for control of myeloablative chemotherapy-induced emesis: A randomized controlled trial. JAMA. 2000 Dec 6;284(21):2755-61. — View Citation

Sigsgaard T, Herrstedt J, Handberg J, Kjaer M, Dombernowsky P. Ondansetron plus metopimazine compared with ondansetron plus metopimazine plus prednisolone as antiemetic prophylaxis in patients receiving multiple cycles of moderately emetogenic chemotherapy. J Clin Oncol. 2001 Apr 1;19(7):2091-7. — View Citation

Treish I, Shord S, Valgus J, Harvey D, Nagy J, Stegal J, Lindley C. Randomized double-blind study of the Reliefband as an adjunct to standard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy. Support Care Cancer. 2003 Aug;11(8):516-21. Epub 2003 Jun 27. — View Citation

Wickham R. Evolving treatment paradigms for chemotherapy-induced nausea and vomiting. Cancer Control. 2012 Apr;19(2 Suppl):3-9. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes of Vomiting	The primary outcome measure we are looking for is the number of vomiting episodes in patients with active wrist bands verse the sham wrist bands.	1 month	No
Primary	Severity of Nausea	One of the primary outcomes we are investigating is the severity of nausea in patients with active wrist bands verse the sham wrist bands.	1 month	No
Secondary	Acute Emetic Episodes	More specifically, the number of episodes of vomiting on Day 1.	1 day	No
Secondary	Severity of nausea	The severity of acute nausea on day 1 of treatment.	1 day	No
Secondary	Delayed severe nausea	The delayed number severe nausea episodes on days 2-5.	5 days	No
Secondary	Delayed emetic episodes	Looking at the number of delayed emetic episodes during days 2-5 of treatment.	5 days	No
Secondary	Rescue Medication Use	Will look at the use of rescue medication throughout treatment.	1 month	No