Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Hot Flashes

Patients in one intervention group are treated twice a week for five weeks with balanced ear acupuncture.The data sets of those subjects who received at least eight balanced ear acupuncture treatments will be compared with those who got NADA acupuncture and those who were not treated.

Patients in the other intervention group are treated twice a week for five weeks with NADA ear acupuncture. The data sets of those subjects who received at least eight NADA ear acupuncture treatments will be compared with those who got balanced ear acupuncture and those who were not treated.

Control group: At the end of the 3-month follow-up, the patients in the control group received 10 ear acupuncture treatments in a group setting.

two auricular acupuncture methods are compared with each other and with no treatment

auricular acupuncture

With this clinical trial we investigate whether auricular acupuncture during adjuvant endocrine therapy has an improving effect on hot flashes, which are often perceived as psychologically and physically stressful in self-assessment of women with breast cancer.

Empirical studies indicate that body acupuncture has positive effects on hot flashes. As auricular acupuncture offers a number of advantages over body acupuncture, a three-armed randomised controlled research design is being used to investigate whether hot flashes caused by endocrine therapy are also reduced by ear acupuncture. Balanced ear acupuncture will be compared with NADA ear acupuncture in terms of efficacy and effectiveness. In addition, the effects of the two forms of therapy on the patients' individual quality of life, fatigue, stress perception and sleep quality will be analysed.

In Germany, one in eight women will develop breast cancer in her lifetime, with a relative 5-year survival rate of 88%. Around 70 % of breast cancer cases are hormone receptor positive. Adjuvant endocrine therapy is recommended to reduce the risk of recurrence.The results of a systematic review show that around 52.4 % to 84.8 % of patients adhere to the treatment. It was also shown that non-adherence to treatment has a negative impact on the risk of breast cancer recurrence and the development of distant metastases, as well as on mortality. Lack of adherence to treatment is related, among other things, to the side effects of endocrine therapy, which significantly reduce quality of life. In particular, musculoskeletal syndrome and sleep disorders lead to discontinuation of endocrine treatment with an aromatase inhibitor. Many patients also suffer from hot flashes, sexual dysfunction, weight gain, bone density loss, depression, cognitive dysfunction and fatigue.

The study focuses on hot flashes, which have a negative impact on sleep and promote symptoms of fatigue. Due to the endocrine therapy, the symptoms are usually more pronounced than the menopause-related symptoms. However, oestrogen-based hormone replacement therapy is contraindicated, while non-hormonal medication such as venlafaxine or gabapentin often have serious side effects. An alternative is body acupuncture, which can decrease hot flashes in women with breast cancer. One of the advantages of acupuncture compared to drug treatments is that it is considered having very few side effects.

With the help of a three-armed randomized controlled research design, this study aims to investigate the efficacy and effectiveness of balanced ear acupuncture compared to NADA ear acupuncture in the treatment of hot flashes caused by endocrine therapy. In addition, the effects of the two forms of therapy on the individual quality of life, fatigue, stress perception and sleep quality of the patients will be analyzed.The respective results will be compared with those of a control group that did not receive acupuncture during the observation period.

Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy

Effect and Effectiveness of Auricular Acupuncture in Improving Hot Flashes During Adjuvant Endocrine Therapy in Women With Breast Cancer: A Randomized Controlled Study

measure for hot flashes, from minimum 0 to maximum 4, with the maximum being the worst outcome

self-administered scale to assess menopausal symptoms and complaints, to evaluate the severity of symptoms over time, and to measure changes pre- and postmenopause replacement therapy, from minimum 0 to maximum 4 with the maximum being the worst outcome

subscale of the MRS, from minimum 0 to maximum 4, with the maximum being the worst outcome

Quality of life; physical and emotional wellbeing: from minimum 0 to maximum 4, with the maximum being the worst outcome, social relationships, sexual life satisfaction, and functionality: from minimum 0 to maximum 4, with the maximum being the best outcome

stress, from minimum 0 to maximum 4, with the maximum being the strongest agreement to the statements

insomnia severity, from minimum 0 to maximum 4, with the maximum being the worst outcome

fatigue, with minimum 1 to maximum 10, with the maximum being the worst outcome

expected effect of the treatment and fulfilling of the expectation, from minimum 1 to maximum 10, with the maximum being the highest expectation

individual extent of hot flashes, from minimum 1 to maximum 10, with the maximum being the worst outcome

Karl and Veronica Carstens Foundation

Kliniken Essen-Mitte

Behaviors and Mental Disorders

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Depression

Fatigue

Multiple Myeloma

Neoplasms, Plasma Cell

Depressive Disorder

Pain

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Hematinics

All Drugs and Chemicals

Liver Extracts

Intervention group: Ear acupressure is performed on both ears with permanent pellets according to the NADA (National Acupuncture Detoxification Association) protocol over a period of 8 weeks (presentation at the study center 1x/week, application of the acupressure patches there; these remain on both ears for 5 days and should be massaged 3x/day by the patients themselves according to the instructions provided).

In addition, patients receive a 30-minute psychoeducational talk at the first treatment appointment to promote their own health competence.

Control group: standard treatment / waiting list Patients in the control group will also receive a one-time 30-minute psychoeducational interview at baseline.

Within the NADA protocol, 5 defined points on the patient's ears are treated according to a standardized concept (shen men, kidney, lung, liver, vegetative I).

Auricular Acupuncture

Claudia Loeffler, Dr

Marcela Winkler, MD

Claudia Loeffler, MD

In the present study, the effect of ear acupressure treatment according to the NADA protocol on the quality of life of patients with multiple myeloma (all stages) will be investigated. Furthermore, the effect of ear acupressure on anxiety and depression, pain, fatigue and sleep of the patients will be assessed.

Auricular Acupuncture in Patients With Multiple Myeloma

The FACT-MM can depict a more comprehensive picture of the patient's health status and collects data on precisely those areas that are most important to the patient himself.

The diagnosis-specific subscale developed in this process assesses pain, fatigue, physical activity, emotional health, and cognitive abilities and represents the primary outcome parameter in this study.

The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.

Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.

Improvement of pain (FACT-MM) questionnaire

The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.

The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval

Robert Bosch Hospital Stuttgart

University Hospital Tuebingen

Nausea

Vomiting

Signs and Symptoms, Digestive

Oculocerebral Syndrome With Hypopigmentation

The subjects in arms A and B will receive auricular acupuncture. The subjects in arms A will receive auricular acupuncture (at 2nd and 4th chemotherapy courses) as well as the sham auricular acupuncture (at the 3rd chemotherapy course).

The subjects in arms A and B will receive auricular acupuncture. The subjects in arm B will receive the sham auricular acupuncture (at the 2nd and 4th chemotherapy courses) and auricular acupuncture (at the 3rd chemotherapy course).

Subjects will be randomized to one of these arms. The subjects in arm A and B will receive auricular acupuncture. Before subjects receive chemotherapy within one day, they will be treated by auricular acupuncture, sham acupuncture, or control group.

Auricular acupuncture

Sham auricular acupuncture

Chih-Hsin Yang, PhD

The purpose of this study is to evaluate auricular acupuncture as an antiemetic treatment compared with sham acupuncture and with no acupuncture in patients receiving moderately-high to highly emetogenic chemotherapy. Acupuncture constitutes a nonpharmacological intervention for chemotherapy-induced nausea/vomiting (CINV). Chinese medicine holds that stimulating select points both on the body and the ear, that lie along meridians or life channels, can relieve diseases.

Chemotherapy-induced nausea and vomiting (CINV) are two of the most commonly reported adverse effects of chemotherapy. Uncontrolled CINV reduces quality of life, leads to delays in treatment, and causes serious metabolic disturbances. Current strategies for preventing acute CINV include combination therapy with a 5-HT3 antagonist and a corticosteroid for moderately-high to highly emetogenic chemotherapy. Similarly, strategies aimed at reducing the incidence and severity of delayed CINV include the combination of a corticosteroid and either a dopamine receptor antagonist or a 5-HT3 antagonist for 3-5 days post chemotherapy. Complete protection from vomiting in the first 24 hours is achieved in as many as 70-90% of patients receiving moderately-high and highly emetogenic chemotherapy; however, standard antiemetics only protect 50% of patients from experiencing nausea during this acute CINV phase. Delayed nausea and vomiting is less well defined and controlled, with as many as 50% of patients experiencing nausea and vomiting in the 3 to 5 day period following the first day of chemotherapy. Both acute and delayed CINV remain a significant problem in patients undergoing high-dose chemotherapy for autologous or allogeneic transplantation where up to 90% of patients experience CINV despite prophylactic strategies. Additional pharmacological interventions are clearly needed to optimize control of CINV. Neurokinin-1 receptor (NK-1) antagonists have been reported to improve the total control rates of acute CINV by approximately 25% compared to the standard combination of a 5-HT3 antagonists and dexamethasone alone. Cocquyt et al., reported that one dose of a NK-1 antagonist administered prior to cisplatin-based chemotherapy prevented delayed emesis in up to 72% of patients. Although promising, the role of these agents in CINV prevention and control is as yet undetermined. Acupuncture constitutes a nonpharmacological intervention for CINV. Chinese medicine holds that stimulating select points both on the body and the ear, that lie along meridians or life channels, can relieve diseases. From the previous studies, the P6 point, also known as the Neiguan point or G-Jo point no. 10, is located 2 cun (Chinese inch, equivalent to the width of an individual's thumb) proximal to the distal wrist crease, between the tendons of the palmaris longus and flexor carpi radialis. P6 acupuncture was shown to reduce the incidence and severity of nausea and vomiting in the postoperative setting, morning sickness, and the P6 transcutaneous electrical stimulation (TCES) therapy was shown to enhance the antiemetic action of ondansetron in patients receiving highly emetic chemotherapy treatment. Auricular acupuncture consisted of needle insertion in one ear at four points: (1) sympathetic - located in the terminal of the inferior antihelix crus; (2) stomach -located around the area where the helix crus terminates; (3) shinmoon - located at the bifurcating point between superior and inferior antihelix crus and the lateral 1/3 of the triangular fossa; and (4) occiput - located at the posterior superior corner of the lateral aspect of the antitragus have been reported to be effective in reducing PONV. The purpose of this study was to evaluate auricular acupuncture as an antiemetic treatment compared with sham acupuncture and with no acupuncture in patients receiving moderately-high to highly emetogenic chemotherapy.

The study is a three group, randomized, examiner-blind, crossover controlled trial. It is to evaluate the efficacy and safety of auricular acupuncture in patients receiving moderately-high to highly emetogenic chemotherapy from National Taiwan University Hospital. 120 eligible patients receiving moderately-high to highly emetogenic chemotherapy who fulfill the inclusion/exclusion criteria and complete the informed consent form will be recruited.

After the washout period of 2 weeks, the subjects will be required to take the medication for preventing acute CINV including combination therapy with a 5-HT3 antagonist and a corticosteroid for moderately-high to highly emetogenic chemotherapy. The patients will be divided into three groups (auricular acupuncture treatment group, sham auricular acupuncture treatment group, and non-treatment group) in order to test the effectiveness of auricular acupuncture. Group 1 patients will receive no treatment (control), after completion of the 1st chemotherapy course, Group 2 patients will receive auricular acupuncture treatment at the 2nd and 4th chemotherapy courses and will receive sham auricular acupuncture at the 3rd chemotherapy course, while Group 3 will receive sham auricular acupuncture at the 2nd and 4th chemotherapy courses and will receive auricular acupuncture at the 3rd chemotherapy course. At baseline visit and course 1, 2, 3, and 4 after chemotherapy, every subject will have efficacy evaluations by FILE, vomiting visual analog scare, WHOQOL-BREF questionnaire and Chinese Disposition Classification. Simultaneously, they will be monitored on their vital signs, complete blood counts, urinalysis, and biochemical indicators at baseline visit and the end of the trial. The collected data will then be analyzed by SAS 8.2 package.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy	NCT06369168	Hot Flashes	auricular acupu...	18 Years - 75 Years	Kliniken Essen-Mitte
Auricular Acupuncture in Patients With Multiple Myeloma	NCT05762250	Multiple Myelom... Fatigue Pain Depression	Auricular Acupu...	18 Years - 70 Years	University Hospital Tuebingen
Stimulation of Auricular Acupuncture-Point for Chemotherapy-Induced Nausea/Vomiting	NCT00360841	Cancer	Auricular acupu... Sham auricular ...	18 Years -	National Taiwan University Hospital
Auricular Acupuncture in Patients With Multiple Myeloma	NCT05762250	Multiple Myelom... Fatigue Pain Depression	Auricular Acupu...	18 Years - 70 Years	University Hospital Tuebingen

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