Auricular Neurostimulation for Chemotherapy-Induced Nausea and Vomiting

Overseen By Angela Steineck, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Developmental delays, Pregnancy, Cardiopulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special ear device using electrical stimulation, known as auricular percutaneous neurostimulation, can alleviate nausea and vomiting caused by chemotherapy. Participants will receive both the active treatment and a placebo during different chemotherapy cycles to compare effects. The trial targets children, adolescents, and young adults who experience moderate to severe nausea from chemotherapy. Ideal candidates are those scheduled for at least two cycles of the same chemotherapy that typically causes nausea and vomiting. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for chemotherapy-induced nausea and vomiting.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that auricular neurostimulation is safe for treating chemotherapy-induced nausea and vomiting?

Research has shown that ear-based nerve stimulation appears safe for people. Studies on similar devices indicate they are well-tolerated and do not cause serious side effects. For instance, the FDA reviewed a similar device for children and teens with stomach pain and found it safe. Other research found that patients using nerve stimulation experienced less nausea and vomiting without major issues. This suggests the treatment is generally safe and could be a good option for managing nausea and vomiting caused by chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about auricular percutaneous neurostimulation for chemotherapy-induced nausea and vomiting because it offers a non-drug alternative to traditional antiemetic medications. Most standard treatments for this condition involve medications like ondansetron or metoclopramide, which can have side effects. This new method uses electrical stimulation targeting specific nerve pathways to potentially reduce nausea and vomiting without the need for pharmaceuticals. Additionally, it provides a unique, non-invasive delivery method that could be more convenient and comfortable for patients undergoing chemotherapy.

What evidence suggests that auricular neurostimulation is effective for chemotherapy-induced nausea and vomiting?

Research shows that using a small device to stimulate a nerve in the ear might help with nausea and vomiting caused by chemotherapy. This trial will compare two treatments: active percutaneous neurostimulation, which targets the vagus nerve to control nausea, and sham percutaneous neurostimulation. Past studies have shown that active nerve stimulation can reduce nausea and improve the quality of life for both children and adults. Early evidence from similar treatments also suggests it can help with other symptoms, like pain. While more research is needed, these findings suggest that ear nerve stimulation could effectively manage chemotherapy side effects. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children, adolescents, and young adults who are about to receive chemotherapy that's known to cause moderate or severe nausea and vomiting. They must have at least one more cycle of the same chemo planned. It's not for those with developmental delays affecting participation, ear infections or skin conditions, uncontrolled infections, electrical implants in their body, pregnancy, severe heart/lung disease, bleeding disorders or psoriasis vulgaris.

Inclusion Criteria

My chemotherapy is known to cause moderate to severe nausea.

I am scheduled for chemotherapy and will have at least one more round of the same treatment.

Exclusion Criteria

Pregnancy

I have been diagnosed with psoriasis vulgaris.

I have a severe ear infection or skin condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active or sham auricular neurostimulation therapy for a maximum of 5 days during chemotherapy admission

5 days

Inpatient admission

Crossover Treatment

Participants cross over to the other group (active vs sham) during the next identical chemotherapy cycle

5 days

Inpatient admission

Follow-up

Participants are monitored for nausea, vomiting, and need for additional antiemetic support up to 7 days after completion of intervention

7 days

What Are the Treatments Tested in This Trial?

Interventions

• Auricular percutaneous neurostimulation
• Sham percutaneous neurostimulation

Trial Overview The study is testing a device called an auricular percutaneous electrical nerve field stimulator against a sham (fake) version to see if it can reduce nausea and vomiting caused by chemotherapy. Participants will be randomly assigned to either the real treatment group or the sham control group.

How Is the Trial Designed?

Group I: Active percutaneous neurostimulation Active Control 1 Intervention

Subject randomized to maximum of 5 days of active vs sham neurostimulation therapy with moderate to severe emetogenic chemotherapy admission . With the next scheduled identical chemotherapy cycle, each subject will cross over to the other one (active vs sham)

Group II: Sham percutaneous neurostimulation Placebo Group 1 Intervention

Subject randomized to maximum of 5 days of active vs sham neurostimulation therapy with moderate to severe emetogenic chemotherapy admission . With the next scheduled identical chemotherapy cycle, each subject will cross over to the other one (active vs sham)

Auricular percutaneous neurostimulation is already approved in United States for the following indications:

Approved in United States as IB-Stim for:

• Functional abdominal pain associated with irritable bowel syndrome (IBS) in pediatric patients

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Auricular acupressure (AA) combined with standard antiemetic treatment significantly improved outcomes for chemotherapy-induced nausea and vomiting (CINV) in 114 breast cancer patients, particularly reducing acute nausea severity compared to standard care alone.

Both true and sham AA groups showed better complete response rates for acute CINV than the standard care group, indicating that AA may have both specific and placebo effects in managing nausea during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of auricular acupressure on chemotherapy-induced nausea and vomiting in breast cancer patients: a preliminary randomized controlled trial. Tan, JY., Molassiotis, A., Suen, LKP., et al.[2022]

Transcutaneous electrical stimulation of the P6 antiemetic point significantly benefited over 100 patients with chemotherapy-induced nausea who did not respond well to standard antiemetics, with more than 75% experiencing considerable relief.

This non-invasive technique, while slightly less effective than acupuncture, is safe and easy to administer, especially when using a simple TENS machine for 5-minute sessions every 2 hours, enhancing the overall antiemetic effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive stimulation of the P6 (Neiguan) antiemetic acupuncture point in cancer chemotherapy. Dundee, JW., Yang, J., McMillan, C.[2022]

Auricular acupuncture during chemotherapy was found to be feasible for breast cancer patients, with 24 out of 26 enrolled participants completing all sessions and assessments.

Patients reported significant reductions in symptom burden, anxiety, and nausea severity after receiving acupuncture during chemotherapy, suggesting potential benefits for managing distressing symptoms associated with treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular Acupuncture During Chemotherapy Infusion in Breast Cancer Patients: A Feasibility Study. Yang, E., Lu, W., Giobbie-Hurder, A., et al.[2022]

This study will compare the effectiveness and safety of auricular acupuncture (AA) and electroacupuncture (EA) in reducing chemotherapy-induced nausea and vomiting (CINV) in 120 participants receiving cisplatin, starting treatment before their first chemotherapy session and continuing for three cycles.

The outcomes will include the incidence and severity of CINV, as well as secondary measures like abdominal distension and quality of life, providing valuable insights into which acupuncture method may be more beneficial for patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of auricular acupuncture versus electroacupuncture in ameliorating chemotherapy-induced nausea and vomiting among patients receiving cisplatin-based regimens. Liu, MY., Sung, L., Liao, YS., et al.[2023]

Nerve electrical stimulation (NES) significantly reduced the severity of nausea and vomiting in patients with advanced gastric cancer undergoing chemotherapy, with P-values of 0.02 and 0.04 respectively.

The NES treatment also improved appetite (P=0.02) without any reported adverse events, suggesting it is a safe and effective option for managing chemotherapy-induced nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nerve electrical stimulation for treating chemotherapy-induced nausea and vomiting in patients with advanced gastric cancer: A randomized controlled trial. Guo, WC., Wang, F.[2020]

Auricular acupuncture was found to be a safe and effective treatment for chemotherapy-induced peripheral neuropathy (CIPN), with 65% of the 73 treated cancer patients reporting satisfaction and 31% experiencing a significant impact on their daily lives.

Efficacy was observed in 96% of patients after just one or two treatments, suggesting that auricular acupuncture could be beneficial if applied earlier during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Auricular Acupuncture in Chemotherapy-Induced Peripheral Neuropathy: A Case Series of 73 Cases. Viel, E., Truong, D., Rambach, L., et al.[2022]

Electrostimulation of the Pericardium 6 (PC 6) point significantly reduces the frequency of acute nausea and vomiting in cancer patients undergoing chemotherapy, based on a systematic review of 14 clinical trials.

The treatment not only helps control nausea and vomiting but also potentially improves the overall quality of life for patients, making it a promising complementary therapy for managing chemotherapy-induced nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Stimulation of PC 6 to Control Chemotherapy-Induced Nausea and Vomiting in Patients with Cancer: A Systematic Review and Meta-Analysis. Garcia, GT., Ribeiro, RF., Faria Santos, IB., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-vomiting-3-2021-2313e

Auricular Neurostimulation for Chemotherapy-Induced ... This study evaluates the efficacy of auricular percutaneous electrical nerve field stimulator in children, adolescents and young adults with chemotherapy ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04721171

Study Details | NCT04721171 | Effectiveness of Electrical ... We hypothesize that 1) Neurostimulation via a novel auricular percutaneous electrical nerve field stimulation (PENFS) device is a safe, non-invasive opioid ...

3. trial.medpath.com trial.medpath.com/clinical-trial/9e5f8486bd5e46cf/nct03434652-efficacy-auricular-neurostimulation-cyclic-vomiting-syndrome

Auricular Neurostimulation for Cyclic Vomiting Syndrome By stimulating a branch of the vagus nerve in the outer ear, this study aims to improve symptoms and quality of life in both children and adults with CVS.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05143554/auricular-neurostimulation-for-chemotherapy-induced-nausea-and-vomiting

Auricular Neurostimulation for Chemotherapy Induced ... This study evaluates the efficacy of auricular percutaneous electrical nerve field stimulator in children, adolescents and young adults with chemotherapy ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37389229/

Percutaneous electrical nerve field stimulation improves ... This is the first study to demonstrate the efficacy of auricular neurostimulation using PENFS for pain and several disabling comorbidities ...

6. ibstim.com ibstim.com/safety-profile/

Safety Profile for IB-Stim The FDA evaluated IB-Stim for safety in patients (11-18 years) with functional abdominal pain and IBS.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10825590/

Opinion: Percutaneous electrical nerve field stimulation ... Percutaneous electrical nerve field stimulation compared to standard medical therapy in adolescents with functional abdominal pain disorders.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9340022/

Percutaneous auricular nerve stimulation ... Neuromodulation with percutaneous electrical nerve field stimulation is associated with reduction in signs and symptoms of opioid withdrawal ...