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17 Study Matches

IMpact of PRehabilitation in Oncology Via Exercise – Breast cancer

It is well known that breast cancer patients suffer from many cancer- and treatment-related side effects that all worsen overall quality of life. Besides dealing with existing treatment-related side-effects, there is the idea of prehabilitation a process on the cancer continuum of care that occurs between the time of cancer diagnosis and the beginning of acute treatment. IMPROVE-B will evaluate an exercise prehabilitation approach with regard to safety, feasibility, acceptability and effectivity in breast cancer patients (n=30) prior surgery.
Joachim Wiskemann at jwiskema@phs.psu.edu or 717-531-0003, ext=289736
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Scheduled for breast cancer surgery
Not metastatic (stage <4)
more than 2 weeks till surgery
Exclusion Criteria:
Receiving neoadjuvant chemotherapy or radiotherapy
Pregnant
• Engaging in systematic intense exercise training (at least 1h twice per week)
Cancer
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Location
Hershey, PA

CUFF Study: Characterization of Upper Limb Function following Mastectomy and Reconstruction for Breast Cancer

This is an observational study that will provide information describing the relationships between type of breast reconstruction and shoulder/upper extremity function and perceived health-related quality of life (HRQOL) for breast cancer survivors. This study will obtain measurements of arm strength and mobility and use self-report questionnaires to evaluate patient quality of life and satisfaction with treatment. Outcomes across three patient groups will be compared, including patients who undergo mastectomy with: 1) no reconstruction; 2) reconstruction with implants; and 3) reconstruction with autologous flaps.
Meghan Vidt at mzv130@psu.edu or 814-865-6885
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Women aged 18-79 years old
Plan to undergo mastectomy as a part of breast cancer treatment
Mastectomy with or without secondary reconstruction
Exclusion Criteria:
Men
Women who do not plan to have mastectomy as a part of their breast cancer treatment
History of a stroke or neuromuscular disorder (e.g. Parkinson's disease, tremor)
Severe arthritis that affects how you move
Any condition that affects memory (e.g. Alzheimer's disease, dementia)
Cancer
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Location
Hershey, PA

Impact of Perioperative Music on Quality of Life Measures and Biomarker Levels in Breast Cancer Patients

Music therapy could improve post-operative quality of life measures and these improvements may correlate with decreased salivary levels of biomarkers that when elevated, traditionally indicate stress, depression, sleep deprivation, and poorer outcomes. This study aims to determine both if music affects molecular mechanisms through measurement of clinical biomarkers as well as if there is an association with significant quality of life measures
Kristine Widders at kwidders@pennstatehealth.psu.edu or 717-531-8815
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Diagnosis of stage 0 to stage
breast cancer as classified by the American Joint Committee on Cancer
Undergoing a mastectomy or lumpectomy at Penn State Hershey Medical Center
Exclusion Criteria:
Difficulties hearing that prevent one from listening to music
Serious oral health or dental conditions
Patient who have undergone pre-operative chemotherapy or pre-operatively radiation therapy
Should not be taking supplements of melatonin or be taking corticosteroids
History of liver cancer, liver disease, or cirrhosis
Cancer
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Location
Hershey, PA

Nurse AMIE: A tablet based supportive care platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)

We propose to build and test a software program called Nurse AMIE (Addressing Metastatic Individuals Everyday) to be provided to Stage IV breast cancer patients on an electronic tablet. This program will be tested in 50 Stage IV breast cancer patients who live within the Penn State Cancer Institute’s 28 county catchment area. Goals of the Nurse AMIE are to regularly assess mental-health, physical health, and other symptom related needs among Stage IV breast cancer patients and to provide appropriate help via videos, weekly calls (face to face, tablet to tablet) with a patient guide at Penn State, and appropriate referrals to phone or in person visits (as needed). The proposed Nurse AMIE software program will allow for the plan of resources (videos, audio files, exercises) to help with many of the common symptoms and challenges experienced by the patients. This is an identified need on the part of both the patients and their medical care teams. Finally, it will also allow patient guides to check in with patients, review responses to surveys, decide whether new or different documents or videos are needed, and connecting the patient to palliative care and other services if additional care is found to be needed.
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
metastatic breast cancer
ECOG<3
English speaking
sufficient vision/hearing or family support
Exclusion Criteria:
Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction).
Patients who are receiving any other behavioral intervention
Cancer
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Location
Hershey, PA

Site for Tomosynthesis Mammographic Imaging Screening Trial (TMIST)_EA1151_PSCI 19-080

This study is being done to answer the following question: Can tomosynthesis mammography, three-dimensional x-ray imaging of the breast, lower your chance of developing life-threatening breast cancer through routine screening compared with digital mammography, two-dimensional x-ray imaging of the breast? We are doing this study because we want to find out which of the two usual approaches to breast cancer screening are better in the early detection of life-threatening breast cancers.
Swati Shah at sshah@pennstatehealth.psu.edu
Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT03233191
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Inclusion Criteria:
Women age 45 or older and under age 75 at the time of study entry
Patients must be scheduled for, or have intent to schedule, a screening mammogram.
Patients must be able to tolerate digital breast tomosynthesis and fullfield digital mammographic imaging required by protocol.
Patients must be willing and able to provide a written informed consent.
Exclusion Criteria:
Women of childbearing potential must not be known to be pregnant or lactating.
Patients must not have new symptoms or signs of benign or malignant breast disease
Patients must not have had a screening mammogram within the last 11 months prior to date of randomization.
Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
Patients must not currently have breast enhancements (e.g., implants or injections).
Prevention, Cancer, Women's Health
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Hershey, PA

CCTG MA.39- A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Purpose of this study is to compare any good and bad effects of not using regional radiotherapy to using radiotherapy. The study will help researcher learn if not giving regional radiotherapy is just as good as using regional therapy to treat node positive breast cancer in women.
Michelle Eschbach at meschbach@pennstatehealth.psu.edu or 610-378-2336
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03488693
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Inclusion Criteria:
Estrogen Receptor Positive / Her2 Negative Breast Cancer
No evidence of metastasis
1
•3 positive lymph nodes
May have had breast conserving surgery or mastectomy
40 years of age or older
Exclusion Criteria:
Nodal disease limited to micromets or isolated cells
History of ipsilateral breast cancer or DCIS
Synchronous or contralateral breast cancer
pT3 or pT4 disease
Neoadjuvant Chemotherapy for breast cancer
Cancer
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Location
Reading, PA

Site for A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL.

This is a drug study with a primary outcome of testing aspirin as therapy versus a placebo pill for patients for breast cancer.
Lea Russell at lmay1@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02927249
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Inclusion Criteria:
Histologic documentation of women or men with HER2 negative breast carcinoma and free of recurrence.
Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed.
Age > 18 and < 70 years of age.
ECOG performance status 0-2.
Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention.
Exclusion Criteria:
No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention.
No history of any prior stroke (hemorrhagic or ischemic).
No concurrent anticoagulation with warfarin, heparin/heparin analogues, clopidogrel, direct thrombin inhibitors, or direct factor XA inhibitors.
No history of atrial fibrillation or myocardial infarction.
No history of grade 4 hypertension, defined as hypertension resulting in lifethreatening consequences
Cancer
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Location
Hershey, PA

Pivotal study of the LUM Imaging System for assisting intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer.

The objective of this prospective, multi-center, single-arm study is to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients in order to assist surgeons in reducing the rates of positive margins.
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03686215
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Inclusion Criteria:
Subjects must have histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or primary invasive breast cancer with a DCIS component.
Female, age of 18 years or older. Because no dosing or adverse event data are currently available on the use of LUM015 in subjects <18 years of age, children are excluded from this study.
Subjects must be scheduled for a lumpectomy for a breast malignancy.
Subjects must be able and willing to follow study procedures and instructions.
Subjects must have no uncontrolled serious medical problems except for the diagnosis of breast cancer, as per the exclusion criteria listed below.
Exclusion Criteria:
Subjects who are treated for bilateral breast cancer resection procedure.
Subjects who are pregnant at the time of diagnosis of their breast cancer.
Subjects who are sexually active and not willing/able to use 2 medically acceptable forms of contraception (hormonal, barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015.
Subjects who have taken an investigational drug within 30 days of enrollment.
Subjects who will have administration of methylene blue or any dye for sentinel lymph node mapping on the day of the surgery prior to imaging the lumpectomy cavity with the LUM Imaging Device.
Cancer
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Hershey, PA

A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE).

This is a drug study that will examine the drug Ribociclib with endocrine therapy versus just endocrine therapy in patients with early breast cancer.
Kathleen Rizzo at krizzo@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03701334
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Inclusion Criteria:
Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization
Patient has breast cancer that is positive for ER and/or PgR
Patient has HER2-negative breast cancer defined as a negative
Patient has available archival tumor tissue from the surgical specimen, for submission to a central laboratory.
If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines
Exclusion Criteria:
Patient has received any CDK4/6 inhibitor
Patient has received prior treatment with tamoxifen, raloxifene or AIs
Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin.
h a known hypersensitivity to any of the excipients of ribociclib and/or ET (
Patient with distant metastases of breast cancer beyond regional lymph nodes
Cancer
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Hershey, PA

Feasibility Study Phase C: Expansion in Multiple Institutions for Training in the Use of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects with Breast Cancer

The main goal of standardizing the training for surgeons and clinical staff that will be participating in the anticipated pivotal study of the Lumicell Imaging System. Identify and address any site-specific or user-specific issues for using the LUM Imaging System in breast cancer patients and to collect safety and efficacy data.
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02438358
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Inclusion Criteria:
Female, age of 18 years or older
Cytology confirmed primary invasive breast cancer, ductal carcinoma in situ or a combination of both
Scheduled for lumpectomy for a breast malignancy
No uncontrolled serious medical problems
Exclusion Criteria:
Subjects who are pregnant at the time of breast cancer diagnosis
Uncontrolled hypertension or other uncontrolled medical problems
Patient who is sexually active and not willing to use contraception-hormonal or barrier method, or abstinence for 60 days after injection
Individuals undergoing a second lumpectomy because of previous positive margins
Subjects who have taken an investigational drug in the 30 days prior to enrollement
Cancer, Women's Health
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Hershey, PA

A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer: Big Ten Cancer Research Consortium (BTCRC-BRE15-016) (16-053)

Primary Objective The primary objective of the Phase II study is to estimate the activity of the combination of palbociclib and tamoxifen in first line therapy for women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease, assessed by response rates (complete or partial response) (RR) based on RECIST 1.1 or MDA criteria (for patients with bone only disease). Secondary Objectives - Characterize safety and tolerability of palbociclib and tamoxifen in first line therapy for women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease. - Evaluate progression-free survival (PFS) per local assessment and RECIST 1.1 or MDA criteria in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen. - Evaluate clinical benefit rate RR (complete, partial response, or stable disease, lasting 24 weeks or longer) based on RECIST 1.1 or MDA criteria in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen. - Measure overall survival (OS) at 2 years in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02668666
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Inclusion Criteria:
Locally advanced, locoregionally recurrent, or metastatic disease, not amenable to curative therapy
Histologically and/or cytologically confirmed diagnosis of ER positive and/or PR positive (ER>1%, PR>1%), Her2 negative breast cancer
No prior systemic anti-cancer therapy for advanced HR+ positive disease
Metastatic disease evaluable on imaging studies.
Adequate blood, liver and kidney function
Exclusion Criteria:
Prior treatment with any CDK 4/6 inhibitor
Confirmed diagnosis of HER2 positive disease
Known uncontrolled or symptomatic CNS metastases.
Prior (neo)adjuvant treatment with tamoxifen within the 12 months before study entry.
Prior history of blood clots, pulmonary embolism or deep vein thrombosis.
Cancer
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Hershey, PA

Phase II Trial of Palbociclib with Fulvestrant in Individuals with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer who have Progressed on Treatment with Palbociclib and an Aromatase Inhibitor

In this phase II trial, we will determine the progression-free survival (PFS) of the cyclin dependent kinase 4/6 inhibitor (CDK4/6i) palbociclib with fulvestrant in women and men with estrogen or progesterone receptor (ER/PR) positive, HER2-negative metastatic breast cancer (MBC) who progressed on treatment with palbociclib and an aromatase inhibitor (AI). We will also determine the prevalence rate of estrogen eceptor α (ESR1) and phosphatidylinositol-3-kinase (PI3K) mutations in the study population.
Lea May at lmay1@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02738866
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Inclusion Criteria:
Men and women, 18 years of age or older
Histologically or cytologically confirmed adenocarcinoma of the breast with evidence of metastatic disease (stage IV) or locally advanced disease,
ER-positive and/or PR-positive tumor (≥1% positive stained cells) • HER2-negative tumor
Progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy for advanced/metastatic breast cancer, and be able and willing to receive additional palbociclib treatment
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria:
Women who are pregnant or breast-feeding
Concurrent use of any of the following medications during study participation: • Inhibitors or inducers of CYP3A4 that may affect serum concentrations of palbociclib
Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before registration.
Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
Prior hematopoietic stem cell or bone marrow transplantation.
Cancer
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Hershey, PA

Women In Steady Exercise Research - Neoadjuvant Exercise Trial

The primary purpose of this pilot study is to determine whether breast cancer patients whom elect to undergo cardiotoxic neoadjuvant chemotherapy can be enrolled and retained in a 6 month at home aerobic exercise training study. Using a randomized controlled trial approach, we will examine the safety and efficacy of a well monitored moderate-to-high intensity aerobic training program completed at home in breast cancer patients receiving neoadjuvant chemotherapy. In addition to assessing safety and efficacy of the program, we will assess intervention effects on cardiopulmonary fitness, cardiac function, and tumor response.
Kathleen Sturgeon at kms99@psu.edu or 717-531-0003, ext=284676
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Stage 1-3 breast cancer
Scheduled to start neoadjuvant chemotherapy
Sedentary
No heart disease
Exclusion Criteria:
Stage 4 breast cancer
Heart disease
Non-English speaking
Cancer
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Study Locations

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Greater Philadelphia Area, PA
Harrisburg, PA
Hershey, PA

Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study

Briefly, the purpose of this study is to use a self-management approach (combining education and exercise) to help older breast cancer survivors manage joint pain, a common side effect of aromatase inhibitors (AIs), a medication used to reduce hormones that might increase risk of recurrence and mortality following primary cancer treatment. We believe that reducing joint pain might help survivors take their medication longer and thus improve survival outcomes, compared to standard care.
Shirley Bluethmann at szb332@psu.edu
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03955627
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Inclusion Criteria:
Age 65 and older
Female
Breast Cancer Survivor
Preparing to Start AI medication
ER+ diagnosis
Exclusion Criteria:
Already taking AI medication (greater than 2 weeks)
Gross Cognitive Impairment
Recent Joint Surgery
Cardiac event/Stroke within last 6 months
Not willing to come to HMC for Exercise Sessions
Cancer
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Hershey, PA

Communication preferences related to over screening for cancer among older adults

The overall objective of this study is to explore the perspectives of older adults on incorporating and communicating risks, benefits and life expectancy into cancer screening decisions. The findings from this study will inform development of an intervention to reduce over-screening for breast, cervical, or colorectal cancers among average risk older adults who are not recommended for screening by current guidelines based on age. Average risk, including age, is defined by screening recommendations. A person is at average risk if they have not had cancer (as defined in the exclusion criteria) or colorectal polyp (within 10 years) or breast biopsy (within 10 years) and they are within the age range. Our hypothesis is that subjects will be more willing to discuss cessation of regular cancer screening risks, benefits, and life expectancy are incorporated into an ongoing dialogue between provider and subject.
Sol Rodriguez-Colon at srodriguezcolon@pennstatehealth.psu.edu or 717-531-5190
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
65 years or older
Willing to participate in focus group discussion
Exclusion Criteria:
Diagnosed with non-skin cancer within the past 5 years
Prevention, Education, Cancer
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Hershey, PA
State College, PA

Bioactive RNA in Infant Nutrition: A Novel Regulator of Developmental Origins and Allergic Response

Characterize longitudinal changes in immune-related ribonucleic acids (RNAs) during the first four months after birth (a critical period when protective breastfeeding benefits are conferred) and compare breast milk RNA exposure between atopic and non-atopic infants. Atopy, the genetic tendency to develop allergic diseases such as asthma and atopic dermatitis (AD), is present in nearly one-third of children. Atopy results from activation of the immune response to environmental exposures. The developmental origins that influence this response are not completely understood. Infants who breastfeed beyond three months have lower atopy risk. What factors in maternal breast milk (MBM) confer these health benefits and why is breastfeeding beyond three months so critical? The answer may be a bioactive factor in MBM called microRNA (miRNA). MiRNAs are small non-coding molecules that regulate gene expression across multiple tissues. There are nearly 1,000 types of miRNAs in MBM. The majority are found in the lipid or cellular milk fractions, and evidence suggests that they regulate metabolic and immune pathways. Studies by our lab and others demonstrate that MBM miRNA composition is influenced by both maternal factors (delivery method and weight) and infant factors (prematurity). Animal studies suggest nutritional miRNA influences the immune system through immune-modulation. Thus, breast milk miRNA exposure may mitigate infant atopy risk.
Alexandra Confair at aconfair1@pennstatehealth.psu.edu or 717-531-5656
Female
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
New breastfeeding mother
Mothers ages 18-50
healthy baby < 7 days old
seeking care at a Penn State Pediatric Clinic
Term baby 37-42 weeks at birth
Exclusion Criteria:
plan to move out of central PA within 1 year
plan to stop breastfeeding before baby is 4 months old
Children's Health
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Hershey, PA

Assessing the Feasibility of Implementing a Storytelling Intervention among African Americans with Hypertension: A Pilot Study

Personal narratives or storytelling is an approach that has been used to promote healthy behaviors among people with diabetes, breast cancer, and high blood pressure. There is a need for low-cost, culturally-tailored interventions that promote healthy behaviors and improve health outcomes in the African American community. The objective of this project is to develop a storytelling intervention for African Americans with high blood pressure. Participants will be filmed sharing their experiences living with high blood pressure, and the videos will be shared with other African Americans with high blood pressure. We are recruiting 6-8 African American adults with high blood pressure, age 18-80, that have been diagnosed with high blood pressure and are taking medications to manage high blood pressure.
Yendelela Cuffee at ycuffee@phs.psu.edu or 717-531-7178
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Diagnosis of hypertension
Prescribed anti-hypertensive medication
Age greater than or equal to 18 years
African American
Exclusion Criteria:
Pregnancy
Unable to speak or read English
Mental status precluding ability to provide informed consent
Heart & Vascular
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Location
Harrisburg, PA
Hershey, PA