Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy

Hyperemesis Gravidarum Clinical Trial

Official title:

Trial of Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy: A Pilot Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05098067
• Other study ID #: 1763191-1
• Status: Completed
• Phase: Phase 2
• Start date: May 24, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: February 2024
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Between fifty and eighty percent of pregnant women experience nausea and vomiting in pregnancy making it one of the most common medical complications of pregnancy. Hyperemesis gravidarum is an extreme form of nausea and vomiting of pregnancy and results in evidence of acute starvation (i.e. large ketonuria), and weight loss (>5% of a woman's pre-pregnancy weight). Hyperemesis gravidarum is also surprisingly common. In fact, it is the second leading cause of preterm hospitalization during pregnancy, second only preterm labor. Hospitalization is often required because hyperemesis is frequently refractory to common anti-nausea medications. However, capsaicin cream, a potent TRPV1 agonist, commonly used to relieve muscular and neuropathic pain, may be able to reduce the symptoms of nausea and emesis in patients with nausea and vomiting of pregnancy. Smaller studies have demonstrated capsaicin to be both safe and effective when used to treat intraoperative nausea during cesarean delivery. To begin to address whether capsaicin cream could be used to reduce preterm admissions and shorten emergency room visits for hyperemesis, this study will randomize women presenting to the emergency room for nausea and vomiting to treatment with capsaicin cream as an adjunctive medication or routine care. The project will investigate the impact of capsaicin cream on hospital length of stay as well as representation for additional treatment. If effective, capsaicin cream has the potential not only to reduce emergency room visits, hospital admissions and overall health care costs, but also to drastically improve patient quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2023
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women in the first trimester (0-14 weeks gestation)
• Presenting to the emergency room at Women & Infants Hospital in Rhode Island with a chief complaint of nausea and vomiting
• English or Spanish speaking
• Have not taken an anti-emetic such as Reglan or Zofran within the 6 hours prior to presentation

Exclusion Criteria:

• Allergy to Reglan, capsaicin or Zofran
• Another identifiable source for nausea and vomiting (i.e. gastritis, COVID, diabetic ketoacidosis)
• Molar pregnancies,
• Patients with a history of gastroparesis
• Patients with a history of preexisting diabetes mellitus

Related Conditions & MeSH terms

• Hyperemesis Gravidarum
• Nausea
• Nausea Gravidarum
• Pregnancy Complications
• Vomiting
• Vomiting of Pregnancy

Intervention

Drug:
• Capsaicin Topical Cream
5g 0.075% applied once
• Metoclopramide
10mg IV once
• Ondansetron
8mg IV once if needed
• Lactated Ringers, Intravenous
1000cc once

Locations

Country	Name	City	State
United States	Women and Infants Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bleehen SS. Pigmented basal cell epithelioma. Light and electron microscopic studies on tumours and cell cultures. Br J Dermatol. 1975 Oct;93(4):361-70. doi: 10.1111/j.1365-2133.1975.tb06509.x. — View Citation

Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x. — View Citation

Dean DJ, Sabagha N, Rose K, Weiss A, France J, Asmar T, Rammal JA, Beyer M, Bussa R, Ross J, Chaudhry K, Smoot T, Wilson K, Miller J. A Pilot Trial of Topical Capsaicin Cream for Treatment of Cannabinoid Hyperemesis Syndrome. Acad Emerg Med. 2020 Nov;27(11):1166-1172. doi: 10.1111/acem.14062. Epub 2020 Jul 20. — View Citation

Gazmararian JA, Petersen R, Jamieson DJ, Schild L, Adams MM, Deshpande AD, Franks AL. Hospitalizations during pregnancy among managed care enrollees. Obstet Gynecol. 2002 Jul;100(1):94-100. doi: 10.1016/s0029-7844(02)02024-0. — View Citation

Piwko C, Koren G, Babashov V, Vicente C, Einarson TR. Economic burden of nausea and vomiting of pregnancy in the USA. J Popul Ther Clin Pharmacol. 2013;20(2):e149-60. Epub 2013 Jul 10. — View Citation

Richards JR, Lapoint JM, Burillo-Putze G. Cannabinoid hyperemesis syndrome: potential mechanisms for the benefit of capsaicin and hot water hydrotherapy in treatment. Clin Toxicol (Phila). 2018 Jan;56(1):15-24. doi: 10.1080/15563650.2017.1349910. Epub 2017 Jul 21. — View Citation

Yosipovitch G, Mengesha Y, Facliaru D, David M. Topical capsaicin for the treatment of acute lipodermatosclerosis and lobular panniculitis. J Dermatolog Treat. 2005 Aug;16(3):178-80. doi: 10.1080/09546630510041079. — View Citation

Yuan LJ, Qin Y, Wang L, Zeng Y, Chang H, Wang J, Wang B, Wan J, Chen SH, Zhang QY, Zhu JD, Zhou Y, Mi MT. Capsaicin-containing chili improved postprandial hyperglycemia, hyperinsulinemia, and fasting lipid disorders in women with gestational diabetes mellitus and lowered the incidence of large-for-gestational-age newborns. Clin Nutr. 2016 Apr;35(2):388-393. doi: 10.1016/j.clnu.2015.02.011. Epub 2015 Mar 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Symptom Control	Time to perceived symptom control as measured by time elapsed between metoclopramide administration and patient request for discharge.	180 minutes
Secondary	Number of Antiemetics Needed for Symptom Control		180 minutes