EXERCISE INTERVENTION:
No exercise intolerance
Patients must be able to travel to one of the study-designated exercise facilities up to three days per week for four weeks during cycle 0, two days per week for cycles 1-8 (32 weeks) and once per week for cycles 9-11 (12 weeks). In addition, patients must be able to attend exercise testing visits as outlined in the Table 1.Required Initial Laboratory Values:
Medical clearance to undergo a symptom-limited cardiopulmonary exercise test (CPET) and vigorous aerobic and resistance exercise training. o Appendix 8: Patients must answer 'No' to all questions. If patients answered 'Yes' to only Questions 8-11, they will be considered eligible upon physician clearance
Men participating in vigorous aerobic exercise for more than 60 minutes per week or resistance exercise two or more days per week
No exercise intolerance
Physically able to exercise and physician consent to start an exercise program
Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment; muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on MEK162 treatment
Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment; note: muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on sonidegib study treatment
Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment; nota bene (NB): muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on MEK162 treatment
Men refusing to exercise a reliable form of contraception
Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment; muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on MEK162 treatment
No exercise intolerance
Subjects planning on embarking on a new strenuous exercise regimen after first dose of study treatment that can result in significant increases in plasma CK levels
Started or planning to start on strenuous exercise regimen after first dose of study treatment (i.e., muscular activities, such as strenuous exercise, that can result in significant increase in plasma CK levels should be avoided while on trametinib treatment)
Planning to embark on a new strenuous exercise regimen after first dose of study treatment; NOTE: muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on binimetinib treatment
Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment; NB: muscular activities, such as strenuous exercise, that can result in significant increases in plasma creatine kinase (CK) levels should be avoided while on MEK162 treatment
Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment; NOTE: muscular activities, such as strenuous exercise, that can result in significant increases in plasma creatine kinase (CK) levels should be avoided whilst on LDE225 treatment
Patients engaged in a resistance exercise training program.
Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment; note that muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on LDE225 treatment
Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment; muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on sonidegib treatment
No exercise intolerance
Joint disease limiting exercise capability
Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment; muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on MEK162 treatment
Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment; NB: muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on MEK162 treatment
Patients who are planning on embarking on a new strenuous exercise regimen that can result in significant increases in plasma creatine kinase (CK) levels
Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment; muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on MEK162 treatment
PHASE II: Any medical contraindication to exercise according to a physician or physician’s designee
PHASE II: Current physical activity level exceeding Centers for Disease Control and Prevention (CDC) guidelines for activity (60 min of moderate-vigorous exercise/day for 5+ days/week (wk) including 3+ days of vigorous intensity activities and muscle-strengthening exercises on 3+ days/wk and bone strengthening exercises on 3+ days/wk for children < 18 and 150 min of moderate vigorous exercise or 75 min of vigorous exercise/wk and 2+ days of muscle strengthening activities for adults >= 18); the CDC guidelines are used to determine exercise prescription in our intervention; individuals already exceeding the guidelines would be unlikely to benefit from participating
Must be able to complete an acceptable muscular strength test (assessed using calculated one-repetition maximum [1-RM]) at baseline in the opinion of the fitness specialist, exercise physiologist, or trained designee administering the test
Currently participate in less than 60 minutes of structured exercise/week
Willing to travel to the exercise facility at University of Southern California (USC)
Men must be obese (BMI > 25) and sedentary (< 60 minutes of structured exercise per week)
Patients with a history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise must be evaluated by their physician to assess if they are suitable to proceed on study
Are unable to travel to the exercise facility at USC
Have an interest in being part of a study to evaluate yoga-derived exercises and eager to practice some kind of relaxation exercise daily for 3 months
Able to understand the exercise program
Able to maintain daily exercise logs
Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention
No obvious medical conditions or physical handicaps which would preclude an exercise regimen as determined by the radiation oncologist
No history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
Regularly engaged in moderate or vigorous-intensity exercise for at least 5 times a week
Inability to exercise
Able to exercise safely on a treadmill\r\n* Eligibility to exercise safely on a treadmill will be determined by physical examination during visit 1; if during visit 2 the subject is unable to complete or exercise safely on a treadmill, then the subject will be considered as withdrawn from the study
The subject is not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week) or weight reduction dieting
No plan to initiate a new program that could affect well-being during the study period (e.g., psychotherapy, new exercise regimen, meditation classes)
Any patient who, in the opinion of the investigators, will be unable to comply with a supervised exercise regimen based on their developmental stage
Currently not practicing yoga as a form of exercise and/or meditation
Does not have neurological or musculoskeletal co-morbidity inhibiting exercise
Has never been diagnosed by health care professionals to have absolute contraindications to exercise testing
Currently practicing yoga as a form of exercise and/or meditation
Has neurological or musculoskeletal co-morbidity inhibiting exercise
Has been diagnosed by health care professionals to have absolute contraindications to exercise testing
Physician consent to participate in vigorous aerobic or resistance exercise training
Men participating in vigorous exercise for 75 minutes or more per week, and/or structured resistance exercise on three or more days per week are not eligible
Currently (previous 6 months) engaged in structured exercise either aerobic or yoga based
Physician (oncologist) clearance to participate in exercise at moderate to high intensity
Participants have not received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session
Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise
Participants have received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session
Physically able to undertake a diet and exercise program
Low to moderate fitness level at baseline (to be assessed via interview with the exercise staff and through the CPET)
Medical clearance based on medical chart review and normal electrocardiogram (ECG) (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention
NON-RANDOMIZED OBSERVATIONAL COMPONENT ELIGIBILITY:\r\nMedical clearance based on medical chart review and normal electrocardiogram (ECG) (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention
Identified as the active or maintenance stage of exercise behavior
Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week
Able to complete an acceptable baseline cardiopulmonary exercise test (CPET), in the absence of high risk electrocardiogram (ECG) findings or other inappropriate response to exercise as determined by the investigator
Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week
Exercise intolerance, defined by a VO2peak below that predicted for active age- and sex-matched individuals
Able to complete an acceptable baseline cardiopulmonary exercise testing (CPET), in the absence of high-risk electrocardiograph (ECG) findings or other inappropriate response to exercise as determined by the investigator
Young adults (YA) survivors who are currently meeting PA guidelines, or individuals who are determined by the investigators to not be physically able to participate in an independent exercise intervention such as hospitalized, wheel chair bound, unable to ambulate independently, on oxygen
Patients participating in a structured exercise program in the past 6 months (mos)
Recent (< 4 week) first diagnosis of a borderline-resectable pancreatic adenocarcinoma, assigned to receive neoadjuvant therapy and surgery at University of Colorado Cancer Center, physician clearance to participate in exercise program
Co-morbid illness that would contraindicate maximal effort exercise testing or participation in regular exercise programming as determined by the treating physician or exercise physiologist
Participation in more than 240 minutes of moderate-intensity exercise per week (as determined by Leisure Score Index of Godin-Leisure-Time Exercise Questionnaire [LSI] questionnaire)
Medical contraindications to home-based exercise or low-fat, high fruit and vegetable diet
Vigorous exercise > or = 60 min/week or moderate exercise > or = 150 min/week; if a combination of moderate and vigorous exercise are preformed, the minutes of moderate exercise/week plus 2 x minutes of vigorous exercise/week > or = 150 min/week
Any patient unable to complete the exercise regimen or deemed a fall risk will be excluded
Medically capable of performing moderate intensity exercise
Have no contra-indication to moderate to vigorous aerobic exercise (e.g., infection, cardiopulmonary disease, musculoskeletal disease, psychiatric condition)
Any uncontrolled illness or physical disability including, but not limited to, infection, cardiopulmonary disease, musculoskeletal or psychiatric condition that contradicts moderate to vigorous aerobic exercise; not able to walk unassisted
Being active (self-reported >= 150 min/week [wk] moderate – strenuous-intensity exercise)
Being inactive (self-reported =< 150 min/wk moderate – strenuous-intensity exercise)
Able to understand the exercise intervention and able to maintain a daily exercise log
Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention
Any physical, psychological illness, and/or medical problems that restricted them from exercise
Able to complete an acceptable baseline CPET, as determined by the absence of remarkable electrocardiogram (ECG) findings or other inappropriate response to exercise
Medical clearance from attending oncologist or attending radiation oncologist to undergo a symptom-limited cardiopulmonary exercise test
Sedentary, as per the leisure score index (LSI) of the Godin leisure-time exercise questionnaire (GLTEQ); participants who perform regular moderate or vigorous intensity exercise at least 5 days/week, for at least 30 minutes/session, are not eligible
Able to complete an acceptable baseline cardiopulmonary exercise testing (CPET), as determined by the absence of remarkable electrocardiography (ECG) findings or other inappropriate response to exercise
Be willing to participate in the exercise and in cognitive behavioral therapy (CBT)
Are regularly engaged in moderate- or vigorous-intensity exercise for at least 150 minutes per week
Less than 120 minutes of exercise per week (as determined by Leisure Score Index of Godin Leisure-Time Exercise Questionnaire [LSI])
Absolute contraindications to maximal exercise testing as recommended by the American Thoracic Society and exercise testing guidelines for cancer patients
Medical or psychiatric conditions (beyond ovarian cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e.g. cardiac, pulmonary, or orthopedic history that would prohibit a program of walking for exercise; psychotic disorders, dementia, inability to give informed consent)
Cardiovascular disease (unless the disease would not compromise the patient’s ability to participate in the exercise rehabilitation program)
Acute or chronic respiratory disease that would compromise the patient’s ability to participate in the exercise rehabilitation program
Acute or chronic bone, joint, or muscular abnormalities that would compromise the patient’s ability to participate in the exercise rehabilitation program
Currently not involved in a regular (3 times per week) exercise program
Have no contra-indication to moderate to vigorous aerobic exercise
Current participation in an intervention targeting diet or exercise
Women who become pregnant while enrolled will be discontinued from the study and will be instructed to exercise, which is the standard recommendation for cancer-related fatigue
Currently underactive (< 60 minutes of moderate intensity exercise per week in the last month) (confirmed by self-report on the Health History Questionnaire)
Have a known urethral stricture, colostomy, or inability to urinate requiring chronic urinary catheter; only men who are cleared by their physician to safely participate in a physical exercise program (including walking and lifting weights) will be eligible for this study
Not previously engaged in regular exercise training (> 1-2 days/week [d/wk] for > 30 minutes/day [min/d]) in the past 6 months
Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise
Be currently enrolled in another intervention study or recently completed a study promoting healthy lifestyle behaviors (diet and/or exercise)
Able to exercise on a treadmill or stationary cycle
CONTROL (HEALTHY) GROUP: Able to exercise on a treadmill or stationary cycle
Must have normal cardiopulmonary exercise test prior to exercise participation.
Individuals who are unable to identify cycling classes in their community for exercise.
By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface
Willing and able to perform moderate intensity exercise at least 5 days per week for 6 months; this consists of a supervised exercise intervention at one of the 15 YMCAs affiliated with our program for 2 days per week; must be willing to perform unsupervised home exercise for the entire 6 months
Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal replacements plus 35 servings of fruits and vegetables/week for 6 months and track food intake and exercise
Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week
By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface
Access to a smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data from these apps viewed by study personnel
Willing and able to perform moderate intensity exercise at least 5 days per week for 3 months; this consists of a supervised exercise intervention at one of the 15 YMCAs affiliated with our program for 2 days per week for 8 weeks, then 1 day per week for 4 weeks; must also be willing to perform unsupervised home exercise for the entire 3 months
Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal replacements plus 35 servings of fruits and vegetables/week for 3 months and track food intake and exercise
Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week
Underlying medical problems that contraindicate unsupervised exercise
Performing less than 75 minutes of structured moderate-intensity or strenuous-intensity exercise per week
Able to complete an acceptable baseline cardiopulmonary exercise testing (CPET) in the absence of high risk electrocardiography (ECG) findings or other inappropriate response to exercise as determined by the investigator
PILOTS I AND II: Body mass index (BMI) of 25 or higher OR < 150 minutes of moderate to vigorous exercise per week OR < 5 servings of fruit and vegetables per day
PILOTS I, II AND III: Capable of participating in moderate-vigorous unsupervised exercise
PILOT III: Less than 150 minutes of exercise per week
Inability to perform exercise with dominant leg
Currently non-active (exercise two days or less per week)
Willing and medically able to exercise safely and independently at a moderate intensity without direct supervision
Have clearance from their primary care provider to participate in a diet and exercise weight control intervention
Sedentary (have not participated in a regular exercise program in the past 12 months)
Willing and able to travel to the exercise facility
Have completed adjuvant chemotherapy and/or radiation within the past 3 years prior to study enrollment (when cytokine levels are predicted to be high) and able to initiate an exercise program
Able to participate in exercise training
Inability to exercise due to musculoskeletal issue, osteoarthritis or underlying cardiac disease
Planning on changing diet or exercise behavior in the next 6 months
willingness to attend weekly exercise intervention sessions at a SNAP Fitness location within 10 miles of the University of Minnesota campus,
Are not free of unstable angina, arrhythmia, or severe systemic disease that would make moderate intensity exercise participation unsafe
Ability to exercise on a treadmill or stationary cycle
Inability to exercise on a treadmill or stationary cycle
Those with contraindications for exercise tolerance test (ETT) testing, including unstable angina or inability to exercise on a treadmill or stationary cycle
Recent fracture or acute musculoskeletal injury that precludes the ability to fully bear weight on all 4 limbs in order to participate in an exercise intervention (PCS study)
Attending surgeon clearance to undergo a supervised exercise training program
Contraindication to exercise training, such as skeletal metastases, symptomatic coronary artery disease, severe anemia, or any condition limiting their ability to participate in an exercise training program