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

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates the feasibility and acceptability of acupressure to the ear (auricular) to address appetite and weight in patients with stage II-IV gastric, esophageal, or pancreatic cancer. Cancer anorexia, the abnormal loss of appetite, directly leads to cancer-associated weight loss (cachexia) through malnourishment, reduced caloric intake, treatment side-effects, and other modifiable risk factors. Cachexia prolongs length of hospital stay for patients, negatively impacts treatment tolerance and adherence, and reduces overall patient quality of life. Auricular acupressure is a form of micro-acupuncture that exerts its effect by stimulating the central nervous system using adhesive taped pellets applied to specific locations on the external ear. The use of these pellets to deliver auricular acupressure has been shown to improve pain, fatigue, insomnia, nausea and vomiting, depression, and quality of life in both cancer and non-cancer settings. Auricular acupressure is a safe, inexpensive, and non-invasive approach to addressing cancer-related symptoms and treatment side-effects and may be effective at improving appetite and weight loss in stage II-IV gastric, esophageal, and pancreatic cancer patients.

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 data supports the effectiveness of the treatment Auricular Acupressure for gastrointestinal cancers?

Research shows that auricular acupressure can help reduce pain in cancer patients, with a study finding a significant reduction in pain intensity and less use of pain medication. Additionally, auricular acupuncture has been found to have effects on the gastrointestinal tract similar to usual drugs, suggesting it may help with gastrointestinal issues. ^{1 2 3 4 5}

Is auricular acupressure safe for humans?

Auricular acupressure is generally considered safe for humans, with most reported side effects being mild and temporary, such as skin irritation, local discomfort, and dizziness. No serious adverse events have been identified in studies. ^{1 2 4 6 7}

How is auricular acupressure treatment different from other treatments for gastrointestinal cancers?

Auricular acupressure (ear acupressure) is unique because it involves applying pressure to specific points on the ear, which can help manage symptoms like gastrointestinal dysfunction and improve quality of life without the side effects often associated with drugs. This treatment is non-invasive and can be used alongside other therapies to enhance overall well-being. ^{2 3 5 8 9}

Research Team

Blake Langley

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Auricular point acupressure as an adjunct analgesic treatment for cancer patients: a feasibility study. [2019]

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

Auricular Acupressure Therapy for Patients with Cancer with Sleep Disturbance: A Systematic Review and Meta-Analysis. [2022]

3. England 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. [2022]

4. Switzerland 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. [2022]

5. Serbia pubmed.ncbi.nlm.nih.gov

[Ear acupuncture has a hypotonic effect on the gastrointestinal tract]. [2015]

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

Adverse events of auricular therapy: a systematic review. [2022]

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

Pilot randomized controlled trial of auricular point acupressure for sleep disturbances in women with ovarian cancer. [2019]

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

Analgesic effect of auricular acupuncture for cancer pain: a randomized, blinded, controlled trial. [2022]

9. China 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]. [2016]