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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates the efficacy of auricular percutaneous electrical nerve field stimulator in children, adolescents and young adults with 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 data supports the effectiveness of the treatment Auricular Neurostimulation for Chemotherapy-Induced Nausea and Vomiting?

Research shows that electrical stimulation, including auricular neurostimulation, can help reduce nausea and vomiting caused by chemotherapy. Studies have found that stimulating specific points, like the P6 point, can decrease the frequency and severity of these symptoms, providing relief for many patients. ^{1 2 3 4 5}

Is auricular neurostimulation safe for humans?

Auricular neurostimulation, including techniques like electrostimulation and auricular acupuncture, has been studied for various conditions and is generally considered safe for humans. Studies have shown it to be a non-toxic procedure with no significant safety concerns reported. ^{1 2 3 4 5}

How does auricular neurostimulation differ from other treatments for chemotherapy-induced nausea and vomiting?

Auricular neurostimulation is unique because it involves stimulating nerves in the ear using small electrical currents, which is different from traditional drug treatments or acupuncture methods. This approach targets specific nerve pathways to help reduce nausea and vomiting without the need for medication. ^{1 3 5 6 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Non-invasive stimulation of the P6 (Neiguan) antiemetic acupuncture point in cancer chemotherapy. [2022]

3. United States 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Auricular Acupuncture in Chemotherapy-Induced Peripheral Neuropathy: A Case Series of 73 Cases. [2022]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Auricular Acupuncture During Chemotherapy Infusion in Breast Cancer Patients: A Feasibility Study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effects of auricular acupressure on chemotherapy-induced nausea and vomiting in breast cancer patients: a preliminary randomized controlled trial. [2022]