Short Title: INSPIRE-CRT
The INSPIRE-LUNG-CRT trial is a prospective, pilot study investigating the efficacy of incentive spirometry on the incidence and severity of pneumonitis in lung cancer patients undergoing concurrent chemotherapy and radiation therapy with immunotherapy maintenance. Despite advancements in treatment modalities, pulmonary complications remain a significant challenge, often leading to diminished functional capacity and quality of life. This trial aims to establish incentive spirometry as a non-pharmacological intervention to reduce these complications, thereby improving clinical outcomes and patient well-being. Lung cancer treatments are frequently associated with pulmonary toxicities, such as radiation-induced pneumonitis and fibrosis, immunotherapy induced pneumonitis, significantly impacting patient outcomes. Incentive spirometry, a device that encourages deep breathing and lung expansion, has shown promise in postoperative settings but is underutilized in oncology.
Study Number:
INSPIRE-CRT
Study Status:
Enrolling
Treatment Agent:
Not Applicable
National Clinical Trial Identified Number: NCT06688422
Disease:
Study Phase:
III
ResearchCancer@CooperHealth.edu
Incentive Spirometry for Respiratory Enhancement (INSPIRE-CRT) pilot Clinical Trial in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy
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Short Title: CC011
The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.
Study Number:
CC011
Study Status:
Enrolling
Treatment Agent:
N/A
National Clinical Trial Identified Number: NCT05896189
Disease:
Study Phase:
III
researchcancer@cooperhealth.edu
Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double- Blinded Controlled Trial
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Short Title: BN012
This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases.
Study Number:
BN012
Study Status:
Enrolling
Treatment Agent:
Not Applicable
National Clinical Trial Identified Number: NCT05438212
Disease:
Study Phase:
III
researchcancer@cooperhealth.edu
A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients with Resectable Brain Metastases
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Short Title: EMBER-4
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return.
Study Number:
EMBER-4
Study Status:
Enrolling
Treatment Agent:
Imlunestrant, Tamoxifen, Anastrozole, Letrozole, Exemestane
National Clinical Trial Identified Number: NCT05514054
Disease:
Study Phase:
III
researchcancer@cooperhealth.edu
A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence
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Short Title: IOV-EAP-402
The objective of this expanded access protocol is to provide access to Out of Specification (OOS) AMTAGVI treatment to patients. This program provides access to OOS AMTAGVI (lifileucel) that does not meet commercial release criteria but does meet Iovance clinical trial release criteria. Patients will be followed for safety and efficacy.
Study Number:
IOV-EAP-402
Study Status:
Enrolling
Treatment Agent:
AMTAGVI
National Clinical Trial Identified Number: NCT05398640
Disease:
Study Phase:
N/A
researchcancer@cooperhealth.edu
Expanded Access Program of AMTAGVI that is Out of Specification for Commercial Release
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Dr. Marks joined Cooper University Health Care as the Vice President and Associate Chief Nursing Officer. Since working as a nursing assistant, emergency department technician, and staff nurse, the patient and the staff has always come at the center of his practice. As a leader, Dr.
Ms. Huster has operational oversight of medical surgical units, interventional pulmonology and respiratory care departments. She joined Cooper in 2020 from Virtua Health System in South Jersey where she served in various nursing roles and leadership capacity for over 15 fifteen years. She served in the United States Army/Reserves for 17 years in various clinical roles from medic to licensed practical nurse and finally as a registered nurse.
Dr. Brapoh joined Cooper University Health Care with 20 years of varied nursing leadership experience in cardiac, research, quality and safety, and professional development.
She had a long tenure as the first Nurse Researcher at Atlantic Health System Overlook Medical Center where guided nurses in developing a culture of inquiry to elevate nursing practice and care delivery. She was also instrumental in increasing nurse engagement in shared governance, which culminated in a successful first Magnet® designation.
In her role as Assistant Vice President, Nursing Operations, Dr. Mapp provides operational oversight for Cooper University Health Care’s Women’s and Children’s Institute, including Obstetrics and Gynecology, Pediatrics, Child Life, Neonatal and Pediatric Critical Care, Cleft Palate Clinic, and the Safe Kids Outreach Program.
