FDA issues warning on CDK inhibitors

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

• NCT03581357: Mobile Mindfulness Meditation to Improve Neuropathy in Cancer Survivors. The studies a mobile app for cancer-related neuropathy in people with breast, colorectal, endometrial, pancreatic, prostate and other cancers, who have finished treatment and are experiencing neuropathy.
• 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. 
• NCT04262180: Physical Activity Promotion for Breast and Endometrial Cancer Survivors. This study is looking at whether messaging and coaching can increase activity level and how moderate-to-vigorous activity improves symptoms and quality-of-life in women diagnosed with breast or endometrial cancer.
• EnergyPoints: A Mobile App Guiding Use of Acupressure for Cancer-related Fatigue and Sleep Disturbances. This study is looking at the use of acupressure to manage cancer-related fatigue and sleep disturbances. 

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. 
• NCT04049695: Improving Cognition After Cancer (ICAN). This study will test whether physical activity can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.
• NCT04086875: A Text-based Tool to Improve Adherence to Hormone Therapy in Patients With Early-Stage Hormone Positive Breast Cancer. This trial studies how well text messaging works to improve adherence to hormone therapy in people with early-stage breast cancer.  
• 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.
• NCT03996265: Bupropion in Reducing Cancer Related Fatigue in Stage I-III Breast Cancer Survivors. This will study how well the drug bupropion (welbutrin) reduces cancer-related fatigue in stage I-III breast cancer survivors.
• NCT02831582: Omega-3 Supplementation to Prevent Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer. This study looks at omega-3 fatty acid supplementation to prevent aromatase inhibitor-induced side effects in patients with stage I-III breast cancer. 
• 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.  
• NCT01802346: Low Calorie Diet to Reduce Side Effects and Increase Response to Chemo in People With Breast or Prostate Cancer. This studies a low calorie diet to reduce side effects and increase response to chemotherapy in patients with breast or prostate cancer. 

Colorectal cancer

• NCT04763174: An mHealth Symptom Management Intervention for Colorectal Cancer Patients (mCOPE). The study will look at a mobile health tool to meet the multiple symptom needs and stage-of-life challenges faced by colorectal cancer survivors. 

Endometrial cancer

• NCT04713618: Changes in Pelvic Health, Sexual Function, and Quality of Life in Women With Pelvic Cancer Undergoing Radiation Therapy. This study looks at changes in physical measures and patient-reported outcomes of sexual function, intimacy and quality of life.
• NCT04298827: Gyn Onc Prehab Study. This study will compare physical therapy, nutritional counseling and cognitive behavioral therapy with physical therapy alone as part of a prehabilitation program. Return of function after surgery, quality of life, patient satisfaction and compliance will be measured. 

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.
• NCT01802346: Low Calorie Diet to Reduce Side Effects and Increase Response to Chemo in People With Breast or Prostate Cancer. This studies a low calorie diet to reduce side effects and increase response to chemotherapy in patients with breast or prostate cancer.