Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Pancreatic Neoplasms

Adenocarcinoma

Esophageal Squamous Cell Carcinoma

Body Weight

Esophageal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Pancreatic Cancer

Esophageal Cancer

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

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

Acupressure Therapy

Best Practice

Biospecimen Collection

Questionnaire Administration

Blake Langley

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.

OUTLINE: Patients are randomized to 1 of 2 arms.

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

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

After completion of study treatment, patients in Arm II are followed up at 8 weeks after active treatment ends.

Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer

A Randomized Controlled Trial Testing the Effects of an Acupressure Intervention on Appetite and Weight in Patients With Gastric, Esophageal, and Pancreatic Cancer: A Pilot and Feasibility Study

Individual participant data that underlie the results reported in published articles after de-identification may be made available upon request (text, tables, figures, and appendices).

Accrual will be measured by the average rate of participants-per-month enrolled into both groups with the goal of 5 patients/month over a 15-month period.

Retention will be measured by the number of participants who remain in the trial and provide data at the closeout visit.

Adherence will be measured in the intervention group by the number of applied auricular acupressure treatments, with the total possible being 8.

Fidelity will be assessed by study team adherence to symptom query and appropriate ear seed point modifications to the standard protocol and accuracy of seed placement according to photographic analysis.

Acceptability will be assessed using a random convenience sample of participants and providers through semi-structured interviews.

As measured by the Functional Assessment for Anorexia/Cachexia Treatment Subscale. Analyses will assess change in each outcome as a change from baseline to week 4.

As measured by the Functional Assessment for Anorexia/Cachexia Treatment Subscale. Analyses will assess change in each outcome as a change from baseline to week 8.

Analyses will assess change in each outcome as a change from baseline to week 4.

Analyses will assess change in each outcome as a change from baseline to week 8.

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

University of Washington

Skin and Connective Tissue Diseases

Breast Neoplasms

Nausea

Vomiting

Breast Diseases

Skin Diseases

Signs and Symptoms, Digestive

Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes.

Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site.

Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.

acupressure therapy

management of therapy complications

nausea and vomiting therapy

Suzanne L. Dibble, DNSc, RN, PhD

RATIONALE: Acupressure may help to reduce or prevent nausea in patients who are undergoing chemotherapy. It is not yet known whether acupressure plus standard care for nausea is more effective than standard care alone for nausea in women who are receiving chemotherapy for breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of acupressure in treating nausea in women who are receiving combination chemotherapy for breast cancer.

OBJECTIVES:

* Compare nausea experience and intensity in women with breast cancer receiving one of three combination therapy regimens when treated with standard nausea care plus acupressure vs standard nausea care alone.
* Compare the quality of life, presence of anxiety, and functional status of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to chemotherapy regimen (doxorubicin and cyclophosphamide vs doxorubicin, cyclophosphamide, and fluorouracil vs doxorubicin with paclitaxel or docetaxel vs fluorouracil, epirubicin, and cyclophosphamide) and treatment setting. Patients are randomized to 1 of 3 arms.

* Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes.
* Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site.
* Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.

All patients complete a daily log during the second or third course of chemotherapy. Quality of life is assessed at baseline and after the last treatment.

PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 2 years.

Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer

Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Behaviors and Mental Disorders

Anxiety Disorders

Patients undergo acupressure over 15-120 seconds at a time for up to 15 minutes. After completion of the session, patients may optionally receive an education session on using acupressure at home.

Receive education session about using acupressure at home

Educational Intervention

Electronic Health Record Review

Clinical Trials Referral Office

Laura S. Rhee, D.O.

This clinical trial evaluates whether acupressure is helpful to reduce anxiety related to chemotherapy. Anxiety is experienced by many patients with cancer. Anxiety can be related to chemotherapy and may contribute to other symptoms, such as nausea and poor quality of life. Some patients diagnosed with cancer express interest in non-medicinal ways to manage symptoms. Acupressure is a noninvasive intervention that can be used for many different symptoms. Acupressure is well tolerated with minimal reports of adverse reactions, making it a good choice for patients with cancer. This study may help researchers learn whether acupressure is useful for managing anxiety in patients undergoing chemotherapy.

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of a nurse- and patient-applied acupressure intervention for patients with anxiety associated with active cancer-directed therapy.

II. Patient-reported changes in acute anxiety associated with both the nurse and self-led acupressure interventions will be ascertained.

OUTLINE:

Patients undergo acupressure over 15-120 seconds at a time for up to 15 minutes. After completion of the session, patients may optionally receive an education session on using acupressure at home.

After completion of study intervention, patients who opted to receive education about using acupressure at home are followed up at 1 week.

Acupressure for Reducing Anxiety in Patients Undergoing Chemotherapy

Acupressure for Anxiety: A Pilot Study of a Nurse-Led Acupressure Intervention for Patients Receiving Chemotherapy

Assessed by the number of patients approached about undergoing acupressure intervention.

Assessed by the number of patients who express interest in the initial acupressure intervention in the chemotherapy unit.

Assessed by the number of patients who express interest in the home acupressure intervention.

Assess by the time recorded for ach nurse-led acupressure intervention in the chemotherapy unit.

Assessed with a brief anxiety questionnaire that inquires about the three different domains of anxiety: cognitive symptoms, emotional symptoms, and physical symptoms. Seven questions are answered using 11-point (0-10) scales with different values assigned to the scale per question (e.g. 0=no anxiety/10=worst possible anxiety or 0=strongly disagree/10=strongly agree).

Mayo Clinic

Nervous System Diseases

Peripheral Nervous System Diseases

Neuroendocrine Tumors

Carcinoma, Ductal

Anus Neoplasms

Neuromuscular Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Bile Duct Cancer

Neuroendocrine Tumor

Gastro-enteropancreatic Neuroendocrine Tumor

Intrahepatic Cholangiocarcinoma

Pancreatic Neuroendocrine Tumor

Anal Cancer

Small Intestine Cancer

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Fluorouracil

Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy.

Patients undergo standard of care oral cryotherapy.

Acupuncture Therapy

Oral Cryotherapy

Quality-of-Life Assessment

Stacey Cohen

This phase II trial investigates how well oral cryotherapy plus acupressure and acupuncture compared with oral cryotherapy alone work in decreasing chemotherapy-induced peripheral neuropathy in patients with gastrointestinal cancer who are receiving oxaliplatin-based chemotherapy. Acupressure is the application of pressure or localized massage to specific sites on the body to control symptoms such as pain or nausea. Acupuncture is the technique of inserting thin needles through the skin at specific points on the body to control pain and other symptoms. Cryotherapy uses cold temperature such as oral ice chips to prevent abnormally increased pain sensation. Giving oral cryotherapy with acupressure and acupuncture may work better in decreasing chemotherapy-induced peripheral neuropathy from oxaliplatin-based chemotherapy in patients with gastrointestinal cancer compared to oral cryotherapy alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy.

ARM II: Patients undergo standard of care oral cryotherapy.

Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer

Pilot Study of Oral Cryotherapy vs. Oral Cryotherapy Plus Acupuncture and Acupressure to Decrease Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy for GI Cancers

Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning with each item measured on a 1-4 scale (1, not at all; 4, very much). The sensory subscale raw scores range from 1 to 36. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms.

Measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5. Incidences of CIPN (grade 2 or higher), pain, fatigue, nausea, and anxiety will be compared between treatment arms using Chi-squared or Fisher's exact tests as appropriate.

The Neuropen is used to assess touch and pressure perception as well as protective pain and sharpness sensation. Touch and pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot. Pain and subjective sharpness sensation will be assessed using the 40-g Neurotip on the dominant foot. Loss of pain and pressure sensation are associated with increased CIPN.

A study-specific 128-Hz tuning fork will be used to assess vibration sensation on dominant lower extremity and dominant upper extremity sites. If the patient feels the vibration for 15 seconds or longer, this is defined as normal. If the patient feels the vibration less than 15 seconds, this is defined as absent or decreased vibration sensation. Vibration sensation is lost sooner in CIPN, which means that shorter duration of vibration scores are associated with increased CIPN.

Adherence to acupuncture treatment among patients in the intervention arm will be described as a proportion with 95% confidence interval. Reasons for treatment non-adherence and delivered dose intensity of chemotherapy will be noted.

Measured by patient-reported (National Cancer Institute \[NCI\] Patient Reported Outcomes \[PRO\]-CTCAE, Brief Pain Inventory \[BPI\], oral dysesthesia) and provider-assessed (CTCAE version 5) grading scales.

The Safeway Foundation

Mental Disorders

Psychotic Disorders

medical chart review

questionnaire administration

quality-of-life assessment

sham intervention

standard follow-up care

Alex Molassiotis, MD

RATIONALE: Acupressure wristbands may prevent or reduce nausea caused by chemotherapy. It is not yet known whether acupressure wristbands are more effective than standard care in controlling acute and delayed nausea.

PURPOSE: This randomized phase III trial is studying acupressure wristbands to see how well they work compared with standard care in controlling nausea caused by chemotherapy.

OBJECTIVES:

Primary

* To assess the clinical effectiveness of self-acupressure using wristbands in addition to standard care in the management of chemotherapy-induced (acute and delayed) nausea compared to patients receiving standard care with sham-acupressure wristbands and standard care alone.

Secondary

* To assess the cost effectiveness and extent of use of usual care in patients using acupressure wristbands in addition to standard care for the management of chemotherapy-induced nausea compared to patients receiving standard care with sham-acupressure wristbands and standard care alone.
* To assess the level of quality of life in patients using acupressure and standard care alone.
* To assess the clinical effectiveness of self-acupressure using wristbands in addition to standard care in the management of chemotherapy-induced (acute and delayed) vomiting compared to patients receiving standard care with sham-acupressure wristbands and standard care alone.
* To ascertain for which emetogenic level of chemotherapy regimens (i.e., high, moderate, or low emetogenic chemotherapy) self-acupressure using wristbands in addition to standard care is more or less effective in terms of nausea compared to patients receiving standard care with sham-acupressure wristbands and standard care alone.
* To ascertain whether any improvement in chemotherapy-induced nausea and vomiting from using acupressure wristbands is different in males and females.
* To ascertain whether there is an age effect from the use of acupressure wristbands in relation to chemotherapy-induced nausea and vomiting.

OUTLINE: Patients are stratified according to gender, age in years (16 to 24 vs \>24 to 50 vs \> 50), and level of emetogenic chemotherapy (high vs moderate vs low). Patients are randomized to 1 of 3 intervention arms:

* Arm I (acupressure group): Patients receive standard antiemetics comprising an oral 5-HT3 receptor antagonist (i.e., Zofran) and oral or IV dexamethasone before and for 3 days post-chemotherapy (for highly emetic chemotherapy); an oral 5-HT3 receptor antagonist (i.e., Zofran) and dexamethasone IV before chemotherapy and a 5-HT3 receptor antagonist or dexamethasone for 2 days post-chemotherapy (for moderately emetogenic chemotherapy); or oral dexamethasone before chemotherapy (for low-emetogenic chemotherapy). Beginning on the morning before chemotherapy, patients wear a pair of SeaBand™ elastic wristbands on each arm for 7 days. Each wristband has a 1-cm protruding round plastic button (stud) pressing the P6 acupoint, located on the anterior surface of the forearm, approximately three-finger width up from the crease of the wrist between the tendons of the Palmaris longus and flexor carpi radialis.
* Arm II (sham acupressure group): Patients receive standard antiemetics as in arm I. Beginning on the morning before chemotherapy, patients wear a pair of elastic wristbands on each arm for 7 days. Each wristband has a flat button pressing the P6 acupoint, located on the anterior surface of the forearm, approximately three-finger width up from the crease of the wrist between the tendons of the Palmaris longus and flexor carpi radialis.
* Arm III (control group): Patients receive standard antiemetics as in arm I. Patients are assessed periodically by questionnaires.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer	NCT05911243	Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Stage II Pancre... Stage III Pancr... Stage IV Pancre...	Acupressure The... Best Practice Biospecimen Col... Questionnaire A...	18 Years - 65 Years	University of Washington
Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer	NCT00046865	Breast Cancer Drug-induced Na...	acupressure the... management of t... nausea and vomi...	18 Years -	M.D. Anderson Cancer Center
Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer	NCT05911243	Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Stage II Pancre... Stage III Pancr... Stage IV Pancre...	Acupressure The... Best Practice Biospecimen Col... Questionnaire A...	18 Years - 65 Years	University of Washington
Acupressure for Reducing Anxiety in Patients Undergoing Chemotherapy	NCT06322615	Hematopoietic a... Malignant Solid...	Acupressure The... Educational Int... Electronic Heal... Questionnaire A...	18 Years -	Mayo Clinic
Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer	NCT04505553	Appendix Carcin... Colon Carcinoma Esophageal Carc... Gastric Carcino... Liver and Intra... Malignant Diges... Pancreatic Carc... Rectal Carcinom... Small Intestina... Anal Carcinoma Digestive Syste... Digestive Syste... Pancreatic Neur...	Acupuncture The... Acupressure The... Oral Cryotherap... Questionnaire A... Quality-of-Life...	18 Years -	University of Washington
Acupressure Wristbands or Standard Care in Controlling Nausea Caused by Chemotherapy	NCT00978185	Anxiety Disorde... Nausea and Vomi... Unspecified Adu...	medical chart r... questionnaire a... acupressure the... quality-of-life... sham interventi... standard follow...	16 Years -	National Cancer Institute (NCI)

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