FDA issues warning on CDK inhibitors
https://www.facingourrisk.org/XRAY/FDA-warning-CDK-inhibitors
Full article: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-severe-lung-inflammation-ibrance-kisqali-and-verzenio-breast-cancer
The U.S. Food and Drug Administration issued a safety alert for CDK inhibitors, including Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib). (9/24/19)
Questions To Ask Your Health Care Provider
- Is it safe for me to continue to take my medication (CDK4/6 inhibitors)?
- I am worried I am risk for lung disease, should I continue to take my medication (CDK 4/6 inhibitor)?
- Are there other medications that are as effective for me as a CDK 4/6 inhibitor?
- What signs or symptoms of lung disease should I be looking for?
- Should I have a chest XRAY or other scan for lung disease?
Open Clinical Trials
The following studies are looking at management of side effects:
Multiple cancers
- NCT02296450: Quality of Life (QoL) Assessment in Cancer Patients and Survivors With Dermatologic Conditions Using Dermatologic QoL Instruments. This large study is designed to see how skin conditions that are related to different kinds of cancer or cancer treatments affect a patient's overall well-being.
- NCT05056077: Tools to be Fit. This is a quality of life study for people with bladder, breast, colon, endometrial, kidney (renal cell carcinoma), ovarian, prostate, or rectal cancer to figure out what tools work best for helping cancer survivors improve their diet and exercise.
- NCT03996265: Bupropion in Reducing Cancer Related Fatigue in Cancer Survivors. This will study how well the drug bupropion (welbutrin) reduces cancer-related fatigue in cancer survivors.
Breast cancer
- NCT04621721: Physical Activity at Home for Relief from Neuropathy Caused by Taxanes in People with Breast Cancer. This study will look at the effects of gain and balance training and resistance exercise (using bands) on gait, balance, and lower extremity muscle strength after a 16-week home-based exercise program compared to educational materials without an exercise program.
- NCT04586530: Telehealth and Memory Study (TAMS). The overall purpose of this trial is to confirm the effectiveness of Memory and Attention Adaptation Training (a cognitive-behavioral therapy) as a treatment for chemotherapy-related cognitive dysfunction among breast cancer survivors.
- NCT02290834: Chemotherapy-induced cognitive and brain changes in older adults with breast cancer. The study will investigate cognitive abilities and brain images before and after chemotherapy to identify people at risk for cognitive side effects and to better understand the effects of treatment on brain structure and function.
- NCT04906200: Web-Based Symptom Monitoring and Self-Management Portal for Adolescent and Young Adult Breast Cancer Survivors. This compares a web-based patient-reported symptom-monitoring and self-management portal to standard therapy in young breast cancer survivors.
- NCT04837820: The Effect of Acupuncture on Cancer-Related Cognitive Difficulties. This study will test whether acupuncture can improve thinking and insomnia in breast cancer survivors. This study will also look at insomnia's link to cognitive difficulties.
- NCT03879629: TrAstuzumab Cardiomyopathy Therapeutic Intervention With Carvedilol (TACTIC). Breast cancer patients receiving Herceptin or other HER2-directed therapy are at risk of heart damage. This study is looking at whether beta-blocker drugs could help prevent this from happening.
Colorectal cancer
- NCT05239338: Preserving Fertility After Colorectal Cancer Study (PREFACE). The PREFACE Study is a study of reproductive health and clinical outcomes among individuals diagnosed with colorectal cancer between age 18 to 49 years.
- NCT06420726: Resistance Exercise and Creatine in Colorectal Cancer. This study aims to assess the feasibilty of combining creatine supplementation with resistance training versus resistance training alone in colorectal cancer survivors.
Ovarian cancer
- NCT04533763: Living WELL: A Web-Based Program for Ovarian Cancer Survivors. This studies a group-based and web-delivered tool for ovarian cancer survivors in increasing quality of life and decreasing stress, depressive mood, anxiety, and fatigue across a 12-month period.
- NCT05047926: Prehabilitation for Advanced Ovarian Cancer Patients. Prehabilitation may improve peri-operative outcomes in patients undergoing cancer surgery. This study will look at structured activity for women undergoing neoadjuvant chemotherapy to improve their physical state prior to surgical intervention and thus improve outcomes.
Prostate cancer
- NCT03971591: Men Moving Forward: A Lifestyle Program for African-American Prostate Cancer Survivors (MMF). This study will look at Men Moving Forward (MMF), a community-based lifestyle intervention that supports adherence to nutrition and physical activity guidelines to promote improved body composition and lessen the side effects of treatment.
- NCT05155501: Pelvic Fascia spARing Radical Prostatectomy TrIAL (PARTIAL). This clinical trial is studying whether pelvic fascia-sparing radical prostatectomy has similar cancer control and sexual function outcomes; and significantly better urinary function, less penile deformity and inguinal hernia risks as compared to radical prostatectomy.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.