E-Newsletter - March 2022
Spotlight on Alliance CCP/NCORP Trials
 

April is National cancer Control month

The month of April has been proclaimed as National Cancer Control Month by the President of the United States since 1938. This month is dedicated to raising awareness for cancer prevention and treatment throughout the U.S.  For many years, the death tolls from cancer have steadily declined, due in part to better education and heightened awareness about how to prevent certain types of cancer, recognize the signs and symptoms of cancer, and how to seek proper treatment. Although cancer is one of the leading causes of death in the U.S., it is also one of the most easily preventable.

The Alliance Cancer Control Program (CCP) / NCORP Research Base conducts innovative scientific studies, including interventional, methodological, and health policy research, to help reduce the incidence, morbidity, and mortality of cancer in broad populations. It is designed to help researchers better understand the factors that affect cancer risk, identify opportunities to prevent cancer or reduce the impact of cancer and/or its treatment on the patient, improve patient quality of life, and evaluate the feasibility and effectiveness of strategies to prevent and control cancer in academic settings, the community and in underserved populations. The program is led by Principal Investigator and Director Electra D. Paskett, PhD, who is the Marion N. Rowley Professor of Cancer Research at The Ohio State University College of Public Health. The Deputy Program Director is Marie E. Wood, MD, who is Director of the Familial Cancer Program at the University of Vermont Medical Center.

In recognition of National Cancer Control Month, let's take a look at the active trials in this program's portfolio. 

Cancer in the Older Adult

:: For patients with stage IV non-small cell lung cancer that is recurrent and advanced ::

Alliance A171901 (Older non-small lung cancer patients (>/= 70 years of age) treated with first-line MK-3475 (pembrolizumab) +/- chemotherapy (oncologist's/patient's choice) is being led by Aminah Jatoi, MD (Mayo Clinic) and Melisa L. Wong, MD, MAS (Univerisity of California San Francisco). This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer. The trial opened on October 1, 2020. Learn more: http://bit.ly/Alliance-A171901

Health Disparities

:: For patients with breast cancer who take endocrine therapy medication ::

Alliance A191901 (Optimizing endocrine therapy through motivational interviewing and text interventions) is being led by Katherine E. Reeder-Hayes, MD, MBA, MSc (University of North Carolina at Chapel Hill). This phase III trial compares an additional support program, using text message reminders and/or telephone-based counseling, with usual care in making sure patients with breast cancer take their endocrine therapy medication as prescribed. Poor medication adherence has been shown to be a serious barrier to effective treatment for patients with breast cancer that is hormone receptor-positive. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed. This trial opened on December 10, 2020. Learn more: https://bit.ly/Alliance-A191901

Prevention

:: For patients with atypical hyperplasia or in situ breast cancer ::

Alliance A211102 (Testing for atypia in random periareolar fine needle aspiration (RPFNA) cytology after 12 months metformin (1,1-dimethyl biguanide hydrochloride) chemoprevention versus placebo control in premenopausal women) is being led by Victoria L. Seewaldt, MD (City of Hope). This randomized phase III trial studies metformin hydrochloride to see how well it works compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in situ breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of metformin hydrochloride may prevent breast cancer. The trial opened on February 1, 2015. Learn more: https://bit.ly/Alliance-A211102

:: For patients with breast cancer carrying BRCA1 mutation ::

Alliance A211801 (BRCA-P: A randomized, double-blind, placebo-controlled, multi-center, international phase 3 study to determine the preventive effect of denosumab on breast cancer in women carrying a BRCA1 germiline mutation) is being led by Judy Garber, MD, MPH (Dana-Farber Cancer Institute). This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation. The trial opened on February 23, 2022. Learn more:https://bit.ly/Alliance-A211801

:: For rural cancer survivors who smoke ::

Alliance A211901 (Reaching rural cancer survivors who smoke using text-based cessation interventions) is being led by Devon Noonan, PhD, MPH, FNP-BC (Duke School of Nursing). This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking. The trial opened on December 1, 2021. Learn more: https://bit.ly/Alliance-A211901

Symptom Intervention

:: For patients with breast cancer undergoing axillary lymph node dissection ::

Alliance A221702 (Axillary Reverse Mapping: A prospective trial to study rates of lymphedema and regional recurrence after sentinel lymph node biopsy and sentinel lymph node biopsy followed by axillary lymph node dissection with and without axillary reverse mapping (ARM)) is being led by V. Suzanne Klimberg, MD, PhD (University of Texas Medical Branch at Galveston). This phase III Alliance trial looks at how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery. The trial opened on May 31, 2019. Learn more: http://bit.ly/AllianceA221702

:: For patients with stage II-III colorectal cancer ::

Alliance A221805 (Duloxetine to prevent oxaliplatin-Induced chemotherapy-induced peripheral neuropathy: A randomized, double-blind, placebo-controlled phase II to phase III study) is being led by Ellen M. Lavoie Smith, PhD, RN, FAAN (University of Michigan). This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy. The trial opened on May 1, 2020. Learn more: http://bit.ly/AllianceA221805

:: For men receiving androgen deprivation therapy to treat prostate cancer ::

Alliance A222001 (A randomized, double-blind, placebo-controlled phase II study of oxybutynin versus placebo for the treatment of hot flashes in men receiving androgen deprivation therapy) is being led by Bradley Stish, MD (Mayo Clinic). This phase II trial compares the effect of oxybutynin versus placebo for reducing hot flashes in men receiving androgen deprivation (hormone) therapy for the treatment of prostate cancer. Androgen deprivation therapy decreases testosterone and other androgens through medications or surgical removal of the testicles. Relative to placebo, low- or high-dose oxybutynin may reduce hot flashes in men receiving androgen deprivation therapy. The trial opened on July 30, 2021. Learn more: https://bit.ly/Alliance-A222001

:: For patients with cancer-associated anorexia ::

Alliance A222004 (A randomized phase III trial of olanzapine versus megestrol acetate for cancer-associated anorexia) is being led by Aminah Jatio, MD (Mayo Clinic). This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss. The trial opened on October 15, 2021.  Learn more: https://bit.ly/Alliance-A222004


Cancer Care Delivery Research

:: For older patients with cancer ::

Alliance A231601CD (Improving surgical care and outcomes in older cancer patients through implementation of an efficient pre-surgical toolkit (OPTI-Surg)) is being led by George J. Chang, MD, MS (University of Texas MD Anderson Cancer Center). This trial looks at how well the use of a pre-surgical toolkit (OPTI-Surg) works in improving surgical care and outcomes in older participants with cancer. In many elderly patients, surgery can greatly affect physical condition and the ability to return to pre-surgery levels of physical functioning. Providing pre-surgical recommendations may help improve participants' recovery rate and functioning after surgery. The trial opened on April 1, 2019. Learn more: http://bit.ly/AllianceA231601CD

:: For patients with breast cancer ::

Alliance A231901CD (Improving patient-centered communication in breast cancer: A RCT of a shared decision engagement system (ShaRES)) is being led by Sarah T. Hawley, PhD, MPH (University of Michigan School of Medicine and Public Health). This trial studies the effectiveness of two interventions on patient-reported outcomes of patient-centered communication and decision-making about breast cancer treatment. The first intervention consists of enhancements to an existing patient-facing breast cancer treatment decision tool called iCanDecide that supports the management of worry, distress, and anxiety as compared to an existing tool. The second intervention consists of a clinician dashboard that populates information after patients view either website regarding any ongoing issues or concerns. The trial opened on January 15, 2021. Learn more: https://bit.ly/Alliance-A231901CD

 

For other articles in this issue of the Alliance E-News newsletter, see below.