Acupressure for Gastrointestinal Cancers

Overseen By Blake Langley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Corticosteroids, Immunomodulators

Disqualifiers: Eating disorders, Immunodeficiency, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acupressure on the ear can improve appetite and weight in individuals with stage II-IV stomach, esophagus, or pancreatic cancer. The treatment, known as Auricular Acupressure (also called Ear Acupressure, Micro-Acupuncture, or Auriculotherapy), involves placing small pellets on the ear, potentially stimulating the nervous system to address appetite and weight issues. Participants will receive either this acupressure treatment along with their usual care or just their usual care. Suitable candidates have these types of cancer and experience significant appetite loss. As an unphased trial, this study provides a unique opportunity to investigate a non-invasive treatment option that could enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be using corticosteroids or immunomodulators for appetite stimulation at the start of the trial.

What prior data suggests that auricular acupressure is safe for cancer patients?

Research has shown that auricular acupressure is safe for cancer patients. In several studies, patients reported only minor side effects. For instance, about 8% to 12% of patients experienced some tenderness on the ear. No serious side effects were reported. Auricular acupressure has also been found to help with symptoms like pain and nausea, suggesting it is a well-tolerated option for managing cancer-related issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about auricular acupressure for gastrointestinal cancers because it offers a non-invasive alternative to standard treatments like chemotherapy and radiation, which often come with significant side effects. Unlike these traditional treatments, auricular acupressure targets specific points on the ear to potentially alleviate symptoms and improve quality of life without the need for drugs or surgery. This approach taps into the body’s natural healing mechanisms and might offer symptom relief with minimal risk, making it an appealing complementary option for cancer patients.

What evidence suggests that auricular acupressure is effective for improving appetite and weight loss in gastrointestinal cancer patients?

Research has shown that auricular acupressure, which uses small pellets on specific spots on the ear, can help with several cancer-related symptoms. Studies have found that it eases common side effects of cancer treatments, such as nausea, vomiting, and fatigue. For instance, it effectively reduces chemotherapy-induced nausea and improves sleep quality in cancer patients. Additionally, auricular acupressure relieves pain in those receiving cancer treatment. In this trial, one group of participants will undergo auricular acupressure in addition to their usual care, while another group will receive usual care only. Although more research is needed on its effects on appetite and weight, these findings suggest it might improve the quality of life for cancer patients. ^{1 2 5 6 7}

Who Is on the Research Team?

Blake Langley

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with stage II-IV gastric, esophageal, or pancreatic cancer who have appetite issues. Participants need access to a phone and electronic device, must not be on certain medications for appetite stimulation, and should not have had acupressure or acupuncture in the last month. They must be able to eat orally and commit to attending treatments at a specific clinic as well as performing self-applied treatments.

Inclusion Criteria

Able to intake food orally and not require sole or supplemental intravenous nutrition at baseline

Able to understand and willing to sign written informed consent in English

I can go to 4 ear acupressure sessions at Fred Hutch South Lake Union Clinic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo auricular acupressure or receive usual care, with blood samples collected on study

8 weeks

Follow-up

Participants in Arm II are monitored for safety and effectiveness after treatment

8 weeks

Extension

Participants may continue to be monitored for retention and acceptability

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Auricular Acupressure

Trial Overview The study tests auricular acupressure's ability to improve appetite and weight in patients with advanced digestive cancers. It involves sticking small pellets onto the ear that are believed to stimulate the nervous system. Patients will receive this non-invasive treatment both at a clinic and by themselves at home.

How Is the Trial Designed?

Group I: Arm I (acupressure therapy) Experimental Treatment 4 Interventions

Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.

Group II: Arm II (usual care) Active Control 3 Interventions

Patients receive usual care on study. Patients also undergo collection of blood samples on study.

Auricular Acupressure is already approved in United States, China for the following indications:

Approved in United States as Auricular Acupressure for:

• Pain management
• Fatigue
• Insomnia
• Nausea and vomiting
• Depression
• Quality of life improvement

Approved in China as Auriculotherapy for:

• Weight loss
• Obesity management
• Appetite regulation

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

In a study involving 90 cancer patients, auricular acupuncture significantly reduced pain intensity by 36% after 2 months, compared to only a 2% reduction in placebo groups, indicating its efficacy as a complementary treatment for cancer pain.

The study highlights that auricular acupuncture can provide substantial pain relief for patients who continue to experience pain despite receiving standard analgesic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic effect of auricular acupuncture for cancer pain: a randomized, blinded, controlled trial. Alimi, D., Rubino, C., Pichard-Léandri, E., et al.[2022]

A study involving 50 cancer patients aged 55-87 showed that auricular point acupressure (APA) significantly reduced pain intensity, with over 55% reduction in 'worst pain' and 57% in 'average pain' after 7 days of treatment.

The treatment was well-accepted, with 78% of participants using less pain medication during the APA treatment, indicating potential for effective pain management; however, further studies with a placebo control are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular point acupressure as an adjunct analgesic treatment for cancer patients: a feasibility study. Yeh, CH., Chien, LC., Chiang, YC., et al.[2019]

In a pilot study involving 47 women with ovarian cancer undergoing chemotherapy, those who received auricular point acupressure (APA) alongside sleep hygiene practices experienced a 65% reduction in sleep disturbance after 4 weeks, as measured by the Pittsburgh Sleep Quality Index (PSQI).

The APA treatment not only significantly improved sleep quality compared to the control group but was also found to be easy for participants to perform, suggesting its feasibility for larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of auricular point acupressure for sleep disturbances in women with ovarian cancer. Kuo, HC., Tsao, Y., Tu, HY., et al.[2019]

Auricular acupuncture (AAP) was found to have effects on the motility and tone of the gastrointestinal tract that were comparable to those of standard medications in a study involving 60 patients.

AAP was applied without any side effects or contraindications, suggesting it could be a safe and effective alternative treatment option in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ear acupuncture has a hypotonic effect on the gastrointestinal tract]. Borozan, S., Petković, G.[2015]

In a study of 147 patients with advanced gastroenteric tumors, the combination of acupressure and magnetic stickers significantly improved quality of life, including appetite, defecation frequency, and sleep, compared to supportive treatment alone.

Both acupressure and magnetic sticker treatments alone also showed benefits, but the combination therapy was the most effective, leading to higher Karnofsky scores and overall quality of life improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combination of acupressure and magnetic sticker improved the quality of life in patients with advanced gastroenteric tumor: a clinical observation]. Che, XY., Pu, HP., Wang, XC., et al.[2016]

A systematic review of various studies found that adverse events from auricular therapy (AT) are generally mild and transient, with common issues including tenderness, dizziness, and local discomfort, but no serious adverse events were reported.

The study highlights the need for improved reporting of adverse events in future AT research, suggesting that while AT appears to be a safe treatment option, more comprehensive data collection is necessary to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of auricular therapy: a systematic review. Tan, JY., Molassiotis, A., Wang, T., et al.[2022]

A systematic review of 13 randomized clinical trials involving 961 cancer patients found no significant evidence that acupuncture or auricular acupressure effectively improves sleep disturbances, either in the short or long term.

While minor adverse events were reported, the overall findings suggest a need for more rigorous and larger studies to better assess the efficacy of these treatments for sleep issues in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Acupuncture and Auricular Acupressure With the Improvement of Sleep Disturbances in Cancer Survivors: A Systematic Review and Meta-Analysis. Wan, Q., Luo, S., Wang, X., et al.[2022]

This pilot trial aims to evaluate the efficacy and safety of auricular point acupressure (APP) using vaccaria seeds on the large intestine point (CO7) for treating gastrointestinal dysfunction after laparoscopic cholecystectomy, involving randomized, double-blind methods with multiple evaluations post-surgery.

The primary outcome measured will be the time to first passage of flatus, with secondary outcomes including abdominal distension, nausea, vomiting, and quality of life, providing a comprehensive assessment of APP's therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of auricular point acupressure treatment for gastrointestinal dysfunction after laparoscopic cholecystectomy: study protocol for a randomized controlled trial. Tan, Y., Zhao, Y., He, T., et al.[2022]

Auricular acupressure significantly improves sleep quality in cancer patients, as evidenced by a reduction in the Pittsburgh Sleep Quality Index (PSQI) score, with a mean difference of -3.88, based on a meta-analysis of 6 trials involving 485 participants.

The intervention showed no serious side effects, with only one trial reporting slight and transient pain, indicating that auricular acupressure is a safe option for managing sleep disturbances in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular Acupressure Therapy for Patients with Cancer with Sleep Disturbance: A Systematic Review and Meta-Analysis. Wang, Y., Zhang, J., Jin, Y., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8357499/

Efficacy of Auricular Acupressure in Prevention and ... Auricular acupressure supplementation benefited delayed chemotherapy-induced nausea and vomiting as well as constipation, diarrhea, and tiredness.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7267873/

The Effects of Auricular Therapy for Cancer Pain The results indicated that auricular acupuncture could reduce the pain score of cancer patients. And there was a statistical difference (SMD = −1.45; 95% CI − ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550830725000205

Auriculotherapy may help to reduce gastrointestinal ... Auricular point sticking and ear scraping effectively treat chemotherapy-induced nausea and vomiting (CINV). Ear scraping is more effective for acute CINV, ...

4. link.springer.com link.springer.com/article/10.1007/s44178-024-00147-z

Effectiveness of auricular acupoint therapy on ... The aim of this study was to verify the effect of AAT on gastrointestinal side effects caused by chemotherapy in breast cancer patients.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2021/3996101

Auricular Acupressure Therapy for Patients with Cancer ... Auricular acupressure can significantly improve the sleep quality of cancer patients with sleep disturbance, with no obvious side effects.

6. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.856093/full

Association of Acupuncture and Auricular Acupressure ... The results of the meta-analysis indicated that cancer survivors treated with acupuncture and AA might not experience a positive effect on sleep ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/15347354231198086

Nurse-Administered Auricular Point Acupressure for ... The side effects of APA were minimal (~8%-12% felt tenderness on the ear). After 3 days of APA, patients reported 38% pain relief, 39% less ...