Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Breast Neoplasms

Chronic Pain

Pain

Breast Diseases

Skin Diseases

Neurologic Manifestations

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Aromatase Inhibitors

Patients with active points related to Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS). The points for AIMSS include (1) points corresponding to body pain location and (2) three points known for alleviating stress and pain (i.e., shenmen, sympathetic, and nervous subcortex)

The same procedure of APA will be applied but the tapes/seeds will be placed on different points (points not related to AIMSS). Participants in the Sham APA Control will receive APA on the five ear points comprising mouth, stomach, duodenum, internal ear, and tonsils. These points are chosen for the Sham APA Control for two reasons: First, they are distinct from the zones of the ear (and the points therein) associated with AIMSS and correspond to body regions in which BCS (Breast Cancer Survivors) are usually pain-free; second, they are equivalent in number to those points used in the APA treatment group and no negative impacts have been observed among these points in our pilot study.

Participants in the Education Control will receive four, 15-minute weekly individual sessions in which the scheduling and duration of interaction with the study staff are identical to the APA and Sham interventions. Educational sessions are intended to reflect usual standard medical care per guidelines from the American Society of Clinical Oncology (ASCO), while also meeting the needs of trial participation, including (1) the knowledge of hormonal therapy and side effects; (2) assessment and management of physical long-term and late effects; (3) assessment and management of psychological long-term and late effects; and (4) dietary (developed by Co-I, van Londen) and physical activity in Breast Cancer Survivors (BCS) (developed by Co-I, Stearns). These materials have been used by the research team, and clinical practice. Materials will be tailored so that they can be delivered within 15 minutes for each session.

Light touch using vaccaria seeds on specific points of the ear

Light touch using vaccaria seeds on different points of the ear (compared to the APA group).

Sham APA control

Participants in the Education Control will receive four, 15-minute weekly individual sessions in which the scheduling and duration of interaction with the study staff are identical to the APA and Sham interventions. Materials will be tailored so that they can be delivered within 15 minutes for each session

Education control

Chao H Yeh, PhD

Aromatase inhibitor therapy has become a standard adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer. Up to 50% of postmenopausal breast cancer survivors exhibit significant aromatase inhibitor musculoskeletal symptoms, defined as severe joint pain and stiffness. Aromatase inhibitor musculoskeletal symptoms in turn has a negative effect on the women's physical function and quality of life, leading to discontinued aromatase inhibitor therapy and causing significant social and economic burden. Given aromatase inhibitor musculoskeletal symptoms' profound effects, the management of aromatase inhibitor musculoskeletal symptoms is an essential component in cancer care.

The investigators propose to test auricular point acupressure- -an innovative, non-invasive, nonpharmacologic, and low-cost intervention- -to manage aromatase inhibitor musculoskeletal symptoms in breast cancer survivors. Auricular point acupressure applies an acupuncture-like stimulation to ear acupoints without using a needle (i.e., seeds are taped to the acupoints) to treat illness/symptoms. Auricular point acupressure is particularly well suited for current challenges of unmet aromatase inhibitor musculoskeletal symptoms management. The investigators propose a randomized controlled trial to (1) determine the efficacy of auricular point acupressure in relieving aromatase inhibitor musculoskeletal symptoms, and (2) examine the inflammatory signaling of auricular point acupressure effects in breast cancer survivors treated with aromatase inhibitor. The investigators will also measure psychological, behavioral, personal, and social factors that may moderate or mediate the effects of auricular point acupressure. The investigators also believe inflammatory cytokines may partially explain the mechanism of action of auricular point acupressure for improved aromatase inhibitor musculoskeletal symptoms and physical function, and plan to measure these.

This study will identify a novel approach to manage aromatase inhibitor musculoskeletal symptoms in postmenopausal breast cancer survivors, with minimal side effects. If successful, the paradigm of pain management will shift from a traditional medical model to a larger integrative medicine and patient-management paradigm to avoid unnecessary evolution towards prolonged disability.

Women with a history of Breast Cancer (non-metastatic) before entering into postmenopausal age

Auricular Point Acupressure to Self-Manage Chronic Pain or Aromatase Inhibitor Musculoskeletal Symptoms in Breast Cancer Survivors: Effectiveness and Scientific Underpinnings

The Brief Pain Inventory-short form (BPI-sf) questionnaire includes assessment of pain location and multiple aspects of severity of pain, numbness, tingling, and stiffness, including worst, least, average pain, and present, as well as the interference with daily activities. The Brief Pain Inventory-short form (BPI-sf) has a total score ranging from 0 to 10 with higher scores indicating more pain.

The Western Ontario and McMaster Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales:

* Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing
* Stiffness (2 items): after first waking and later in the day
* Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.

The WOMAC score range from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

QuickDASH outcome measure is used. At least 10 of the 11 items must be completed for a score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a score out of five. The value is then transformed to score out of 100. The score range will be 0 to 100. Higher score indicating greater disability.

Handgrip strength is a simple and commonly used test of a person's general strength level. There is a simple norm table which is categorized with age is used to measure the strength.

Analgesic use and Aromatase Inhibitor (AI) adherence will be included in the Ecological Momentary Assessment (EMA) diary during intervention and medications will be checked at study visits at follow-ups.

Johns Hopkins University

Musculoskeletal Diseases

Arthralgia

Joint Diseases

Micronutrients

Hematinics

Vitamins

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Trace Elements

Folic Acid

Methylcobalamin

Vitamin B12

Cobalamin

Cyanocobalamin

Folate

Vitamin B9

Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)

Zeina Nahleh, MD

Significant Aromatase Inhibitor-associated toxicity, affects as many as 50% of patients with breast cancer leading to early discontinuation of this life-saving cancer treatment. No effective pharmacologic therapy has yet been identified for management of these symptoms, as many patients do not experience relief of symptoms with analgesic therapy. Vitamin B12, whether as injection or oral forms, has been used as a naturopathic product to provide relief for joint pain caused by arthritis. This effect has not been studied in the setting of Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS).

Primary Objectives:

a. To assess whether daily oral Vitamin B12 decreases average joint pain in women with aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), as measured at baseline, 6 weeks and at 12 weeks by the modified Brief Pain Inventory Short Form (BPI-SF).

Secondary Objectives:

1. To investigate whether daily vitamin B12 improves functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES);
2. To explore the impact of treatment on serum inflammatory cytokine levels (C Reactive Protein) with 12 weeks of treatment between baseline and 12 weeks.

Vitamin B12 is to be taken sublingually on a daily basis for 90 days

Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms

A Single Arm Phase II Study of Oral Vitamin B12 for the Treatment of Aromatase Inhibitors (AI) Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer

The Brief Pain Inventory - Short Form (BPI- SF) average pain score used. This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine" We expect at least 20% improvement in BPI-SF pain scores. Participants were asked to rate worst pain an average pain within the last 24 hours.

Analysis of the data collected at baseline and at the end of treatment in the BPI-SF questionnaire. The Brief Pain Inventory - Short Form (BPI- SF) worst pain score used. This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine". Participants were asked to rate worst pain an average pain within the last 24 hours.

All of the items in this questionnaire have a 5 scale rating, from not at all (0) to very much (4). Outcomes were measured pre and post treatment. Version 4 of the FACT-ES contains 3 subscales with seven questions: Physical Well-Being (PWB) (score range 0-28), Functional Well-Being (FWB) (score range 0-28), and Social and Well-Being (SWB) (score range 0-28); Emotional Well-Being (EWB) (score range 0-24) with six questions, and the Endocrine Symptom Subscale (ESS) (score range 0-76) containing 19 questions. For all subscale a higher score represents better quality of life.

Inflammatory markers were measured pre and post treatment.

Texas Tech University Health Sciences Center, El Paso

Professor

Oral Vitamin B12

Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)

Arm I

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Five of 41 participants did not complete the study medications and were not analyzed

Zeina Nahleh, MD (previoulsy PI at Texas Tech university HSC-EP)

A total of forty-one patients were enrolled, five patients withdrew, leaving thirty-six patients to complete the study.

Percentage Change in Average Joint Pain in Women With Aromatase Inhibitor-associated Musculoskeletal Symptoms (AIMSS) Compared to Baseline as Measured by the Brief Pain Inventory Short Form (BPI-SF).

Postmenopausal women with ER+ breast cancer, stages I-III on aromatase inhibitors and musculoskeletal pain (average pain level \> or=4 using BPI-SF)

Percentage Change in Worst Pain at the End of Treatment .

This analysis is comparing EWB before and after treatment.

This analysis is comparing PWB before and after treatment.

This analysis is comparing FWB before and after treatment.

This analysis is comparing ESS before and after treatment.

postemneopausal women with ER + , Stages I-III breast cancer

Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)

HCys

Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA).

Overall Study

Breast cancer patients beginning Aromatase Inhibitor therapy

Other

Karen K Swenson, RN, PhD

Current guidelines recommend endocrine treatment with aromatase inhibitors (AIs) in post-menopausal women with hormone receptor-positive breast cancer. Musculoskeletal symptoms are commonly reported with AI treatment,however, we do not have consistent methods to measure these symptoms prospectively. This gap in our knowledge inhibits the ability to test and develop treatments for AI-associated musculoskeletal symptoms. This pilot study will evaluate functional tests and standardized instruments for their ability to prospectively assess musculoskeletal symptoms in women being treated with AIs for breast cancer.

Specific Aims: 1) identify a core set of instruments for measuring musculoskeletal symptoms, 2) model the time course and predictors of change in musculoskeletal symptoms, 3) explore the effect of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment.

Methods: We will prospectively assess musculoskeletal symptoms due to treatment with aromatase inhibitors. Post-menopausal women beginning AI treatment for hormone responsive breast cancer will be invited to join this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Auricular Point Acupressure to Self-Manage Chronic Pain or Aromatase Inhibitor Musculoskeletal Symptoms in Breast Cancer Survivors: Effectiveness and Scientific Underpinnings	NCT03697200	Aromatase Inhib... Musculoskeletal... Postmenopausal ...	APA Sham APA contro... Education contr...	18 Years -	Johns Hopkins University
Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms	NCT03069313	Relief of Joint...	Vitamin B12	18 Years -	Texas Tech University Health Sciences Center, El Paso
Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors	NCT01074320	Breast Cancer	Other	18 Years -	HealthPartners Institute

Spots Global Cancer Trial Database for musculoskeletal symptoms