Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.

Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.

Michael Harrison, MD

The purpose of this study is to determine the effect of a sunitinib administration schedule 2/1 (2 weeks of treatment followed by 1 week without) compared to a schedule 4/2 (4 weeks of treatment followed by 2 weeks without) on cardiopulmonary function in subjects with renal cell carcinoma. Subjects will be randomized 1:1 to one of two arms: 4/2 schedule of sunitinib administration or 2/1 schedule of sunitinib administration. Cardiopulmonary function will be assessed at baseline, week 4 (4/2 schedule only), week 5 (2/1 schedule only) and week 12. The investigators hypothesize that schedule 2/1 of sunitinib is not only better tolerated but will be associated with less fatigue and functional cardiovascular/muscular toxicity than the 4/2 schedule.

Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing

Exercise Capacity will be assessed using Cardiopulmonary Exercise Testing (CPET) to determine VO2peak. Higher VO2 peak measured in mg/ml/min indicates better cardiac function. Mean change in cardiac functions will be assessed by the difference in Relative Peak VO2 from baseline to 12 weeks in both the arms.

Mean change in cardiac functions will be assessed by the difference in LVEF measured by 2D-Echo from baseline to 12 weeks in both the arms. Higher LVEF measured in percentage indicates better cardiac function.

Mean change in upper and lower extremity maximal muscular strength as measured by the voluntary one-repetition max (1-RM) between week 12 and baseline. A 1-RM is defined as the greatest resistance that can be moved through the full range of motion in a controlled manner. This assessment included following exercises: leg press, chest press, and row. The heaviest weight lifted while adhering to the strict technique and form will be used to score the assessment.

Mean change in upper and lower extremity maximal muscular strength as measured by the muscular endurance which is 70% of 1-RM between week 12 and baseline. Muscular Endurance of the upper and lower body will be assessed as the number of repetitions to fatigue at 70% of the 1-RM. The same exercises and methods will be used as in the 1-RM determination.

The 5-repetition Chair-Stand Test measures the time taken to complete 5 repetitions of the sit-to-stand maneuver performed on a chair. Standardized instructions are: "By the count of 3, please stand up and sit down as quickly as possible for 5 times. Place your hands on your lap, and do not use them throughout the procedure. Lean your back against the chair's backrest at the end of every repetition." Note: Timing will start when the subject's back left the backrest and will be stopped once the back touched the backrest.

Timed Up and Go (TUG) test assesses a person's mobility. TUG measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. Scores of 10 seconds or less indicate normal mobility, 11 - 20 seconds are within normal limits for frail, elderly, and disabled subjects, and greater than 20 seconds suggests that further examination is required.

Subjects will be instructed to cover the longest distance possible in 6 minutes under the supervision of an exercise physiologist or trained designee. The walked distance will be determined in a measured corridor between 2 cones that were placed 30 meters apart

Mean change in PRO: FACIT-Fatigue (FACIT-F, range 0 to 52) aggregate score between week 12 and baseline. Higher scores indicate better quality of life.

Mean change in PRO: FKSI- 19 (FKSI-19 Range 0 to 76) aggregate score between week 12 and baseline. Higher scores indicate better quality of life.

Mean change in PRO: HADS (HADS, range 0 to 21) aggregate score between week 12 and baseline. The HADS score has 2- subscales: Depression and Anxiety. Each sub-scale ranges from 0, 21. Higher scores indicate higher levels of depression and anxiety.

Mean change in PRO: Godin-Leisure questionnaire aggregate score between week 12 and baseline. This represents the activity level of a participant. There are no standard reference range for this assessment. Higher scores indicate higher physical activity.

Duke University

Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.

Schedule 4/2

Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.

Schedule 2/1

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Body Mass Index (BMI)

Change in Relative VO2 Peak From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules

Change in Difference Between Rest Left Ventricular Ejection Fraction (LVEF) and Cardiac Function by 2-D Echocardiography (2DE) From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules

Change in Difference Between Rest and Stress Left Ventricular Ejection Fraction (LVEF) and Cardiac Function by 3-D Echocardiography (3DE) From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules [Time Frame: Baseline, Week 12]

Seated Row

Chest Press

Leg Press

Change in One Repetition Maximum (1RM) in Upper and Lower Extremity Muscular Strength From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules

Change in Muscular Endurance in Upper and Lower Extremity Muscular Strength From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules

Change in Muscle Cross-sectional Area (CSA) of the Major Muscles Near Lumbar3 (CT Scans and Slice-O-Matic® Software) From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules [Time Frame: Baseline, Week 12]

Change in Time Taken to Complete the 5-repititionChair-stand Test From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules

Change in Time Taken to Complete the Timed up and Go Test From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules

Change in Distance Walked During the 6 Minute Walk Test From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules

Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale Score From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules

Change in Functional Assessment of Cancer Therapy - Kidney Symptom Index - 19 (FKSI-19) Score From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules

Change in Anxiety (HADS)

Change in Depression (HADS)

Change in Hospital Anxiety and Depression Survey (HADS) Score From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules

Change in Leisure Activity Score From the Godin-Leisure Questionnaire From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Quality of Life

preoperative: exercise counseling postoperative : symptoms counseling and pulmonary rehabilitation

preoperative and postoperative exercise program

comprehensive intervention

Jae Ill Zo

This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following

This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following:

1. understanding multi-dimensional factors affecting cardiopulmonary function and quality of life
2. development of multidisciplinary comprehensive intervention
3. evaluation the effects of comprehensive intervention using cluster design

Development of Patient Tailored Guideline of Physical Activity for Lung Cancer

Development of Patient Tailored Guideline of Physical Activity for Lung Cancer Survivor After Surgery; to Improve the Symptoms, Complications and Quality of Life

forced expiratory volume at one second, forced vital capacity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing	NCT03109015	Carcinoma, Rena...	Sunitinib Sunitinib	18 Years -	Duke University
Development of Patient Tailored Guideline of Physical Activity for Lung Cancer	NCT03215537	Lung Cancer	comprehensive i...	19 Years -	Samsung Medical Center

Spots Global Cancer Trial Database for cardiopulmonary function