Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Rare Diseases

Breast Neoplasms

Lymphoma

Cardiotoxicity

Breast Diseases

Skin Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Lymphosarcoma

Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.

Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .

Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

Magnetic resonance imaging

Tailored aerobic exercise program onsite and at home.

Physical Activity

Healthy living presentations at a centralized meeting place and over the phone.

Healthy Living

Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.

Cardiopulmonary Exercise Testing (CPET)

A self-administered 13-item scale to assess fatigue in participants

Questionnaire Administration

William Hundley

This trial studies how well magnetic resonance imaging (MRI) works in detecting heart damage in patients with cancer receiving chemotherapy. Diagnostic procedures, such as MRI, may help doctors predict whether patients will have heart damage caused by chemotherapy in patients with cancer receiving chemotherapy.

Exercise Capacity Addendum Brief Summary: This study is designed to demonstrate feasibility of performing the physical activity intervention and the primary outcome measures before, during and six months after initiating Anth-bC for treatment of non- or Hodgkin lymphoma. This study will test the potential for a novel (lifestyle) intervention designed to improve exercise capacity, health-related quality of life and cardiac and cognitive dysfunction. This data will inform the development of the R33 phase of the clinical trial to determine if the physical activity intervention can reduce exercise intolerance in this high-risk population. In addition, cardiac MRI data from individuals within this pilot will be compared to cardiac MRI data from individuals in the parent study that did not undergo either of the two interventional arms of this study.

PRIMARY OBJECTIVES:

I. To design an automated MRI hardware/software platform for measuring and reporting left ventricular (LV) function (volumes, strain, and ejection fraction \[EF\]), T1 myocardial signal, and aortic pulse wave velocity (PWV).

II. To determine if pre- to 3 month post-anthracycline-based chemotherapy (Anth-bC) changes in our MRI platform generated measures of LV volumes, EF, strain, myocardial T1, and aortic PWV predict pre- to 24 month post-Anth-bC differences in these same parameters.

OUTLINE:

Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

Exercise Capacity Addendum Objectives:

Primary Objective:

* To provide critical participant enrollment data necessary to accomplish the R01 submission, including:
* Feasibility of screening, enrolling, and randomizing 21 Non or Hodgkin lymphoma and stage I-IV breast cancer patients including the reasons for failed randomization,
* Identification of barriers for participating in, or adhering to the Patient ES-AI and the Healthy Living Control Group.

Secondary Objective:

• In these 21 patients, at study initiation then 3 and 6 months after initiating Anth-bC or other potentially cardiotoxic cancer therapies, to assess the ability to ascertain: peak exercise cardiac output, calculated arteriovenous oxygen difference (A-V O2) and VO2 (maximum rate of oxygen), and pre-exercise measures of left ventricular and cognitive function, health-related quality of life, six-minute walk distance (6min WD) and fatigue. Ascertainment of the left ventricular function and health-related rate quality of life will be attempted in a manner similar to ascertainment of these variables from 47 individuals with lymphoma in the parent study.

For the exercise capacity portion of this trial, participants will be randomized to 1 of 2 arms.

MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum

Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment - An Addendum to NIH R01CA167821 "Early Imaging Detection of Cardiovascular Injury After Cancer"

The number of participants who completed the intervention.

Number of participants who completed the 6-minute walk test at 6-months.

Peak exercise cardiac output refers to the amount of blood that the heart pumps out per minute. It is an important measure of how effectively the heart is working to deliver oxygen and nutrients to the body's tissues. Peak exercise cardiac output was measured in a cardiac magnetic resonance imaging (MRI) exam.

Arteriovenous Oxygen Difference (A-V O2) is the difference in oxygen levels between arterial blood and venous blood. A-V O2 difference is important because it reflects how much oxygen is being used by the body's tissues during exercise or physical activity. A higher A-V O2 difference is generally considered better.

Maximum rate of oxygen consumption (VO2) is an objective measure of cardiorespiratory fitness. VO2 was assessed with a cardiopulmonary exercise test (CPET). Higher VO2 represents greater cardiorespiratory fitness.

Left ventricular ejection fraction (LVEF, %) is a measure of cardiac function. LVEF was assessed with a cardiac magnetic resonance imaging (MRI) exam. The higher the LVEF, the more efficiently the heart is at pumping blood to the rest of the body with every heart beat.

The COWA test was used to assess cognitive function and verbal fluency. Participants were asked to produce as many words as they can that begin with the given letter (i.e. T or L) within a 1-min time period. The COWA test total score was measured by summing the total number of acceptable words produced for three different letters. Minimum possible score for the COWA text is 0. There is no maximum possible score. Higher scores represent greater verbal fluency.

The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) is a 42-item scale used to assess the health-related quality of life of lymphoma survivors. The FACT-Lym questionnaire examines the four primary domains of HRQL: physical, social, emotional, and functional well-being, and patient's concerns related to lymphoma. The FACT-Lym was examined as a total score, ranging from 0 to 168 points. Higher scores reflect better health-related quality of life.

The 6-minute walk test is a low cost sub-maximal exercise test that serves as an indirect measure of cardiorespiratory fitness. Participants were instructed to walk at their own pace to cover as much ground (in meters) as possible for 6 minutes.

The FACT-fatigue is a 13-item scale that has been widely used to assess cancer-related fatigue. The FACT-fatigue questionnaire was scored by summing all 13 items with a reverse point system. This produces a range of 0 to 52, with a higher score indicating better functioning and less fatigue.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.

Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

Physical Activity: Tailored aerobic exercise program onsite and at home.

Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.

Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants

ADDENDUM: Physical Activity Intervention

Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .

Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.

Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.

Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants

ADDENDUM: Healthy Living Instruction Group (Control Arm)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Diagnosis: Hodgkin Lympoma, Non-Hodgkin Lymphoma, Breast Cancer

Project Manager

Number of Participants Completing the Trial (Exercise Capacity Addendum)

Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)

Peak Exercise Cardiac Output (Exercise Capacity Addendum)

Hospital restrictions due to COVID-19 prevented the data collection of A-V O2 on all participants who completed the study.

Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum)

Hospital restrictions due to COVID-19 prevented the data collection of VO2 on all participants who completed the study.

Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum)

Hospital restrictions due to COVID-19 prevented the data collection of LVEF on all participants who completed the study.

Left Ventricular Function (Exercise Capacity Addendum)

Hospital restrictions due to COVID-19 prevented the data collection of the COWA test on all participants who completed the study.

Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum)

Some participants refused or failed to complete the FACT-Lym survey at 6-months.

Health-Related Quality of Life (Exercise Capacity Addendum)

6-minute Walk Distance (Exercise Capacity Addendum)

Some participants refused or failed to complete the FACT-Fatigue survey at 6-months.

Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum)

Overall Study

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Hematinics

All Drugs and Chemicals

Anti-Infective Agents

Liver Extracts

Carbamide Peroxide

2 resistance training session per week using a home-based resistance training pack and 75 minutes of vigorous or 150 minutes of moderate aerobic exercise per week (as per UK government guidelines) for 12 weeks. They will have 4 assessment points, pre-op, prior to the start of the exercise programme postoperatively, at 6 weeks post commencement of exercise and at 12 weeks to conclude the study. The assessment will include bloods, cardiopulmonary exercise testing, muscle ultrasound to ascertain muscle structure, functional composite scores and quality of life questionnaires.

This group will receive standard postoperative care. They will also have 4 assessment points, pre-op, prior to the start of their standard postoperative care, 6 and finally 12 weeks later to conclude the study. The assessment will include bloods, cardiopulmonary exercise testing, muscle ultrasound to ascertain muscle structure, functional composite scores and quality of life questionnaires.

Aerobic and resistance training 12 week exercise programme

full blood count, urea \& electrolytes, C-reactive protein, coagulation screen, liver function tests, erythrocyte sedimentation rate.

Venous blood sampling

Ultrasound of vastus lateralis to ascertain muscle structure (thickness, pennation angle and fascicle length)

Muscle Ultrasound

The assessment of anaerobic threshold as a measure of changes in aerobic function between the two groups will be assessed using CPET

Cardiopulmonary exercise testing (CPET)

The use of validated questionnaires to assess quality of life parameters; Duke Activity Status Index (DASI), EORTC-QLQ C30 (quality of life for cancer patients) and the International Physical Activity Questionnaire (IPAQ).

Quality of life questionnaire completion

Melanie Paul, MBChB, MSc

Bethan Phillips, AFHEA

Melanie Paul, MBChB, MSc, MRCS

Jon Lund, MD, FRCS

Participants will undergo preoperative baseline screening and will be randomised to either normal postoperative care or a 12-week supervised exercise programme comprising of both an aerobic and resistance component

They will be assessed prior to surgery which will include cardiopulmonary exercise testing (CPET). This is a well-established method of assessing aerobic exercise response and is widely used in the perioperative period for assessment of cancer patients with co-morbidity. The assessment days will also include:

* muscle ultrasound (vastus lateralis) to ascertain muscle structure (thickness, pennation angle and fascicle length),
* blood tests,
* functional composite scores,
* quality of life questionnaires,

The assessment days will be carried out at four time points during the study; prior to surgery, before commencement of the exercise program, halfway through the intervention (6 weeks post commencement of exercise) and at the end of the study. In the week before the assessment days patients will wear a physical activity monitor to characterise their daily movements. The control group will also be assessed at the same time points and wear the activity monitors but will not take part in the exercise program.

All participants will have a physical activity monitor placed onto the right thigh in the midline at postoperative day 1 until discharge or day 7, whichever is sooner. This is a non-invasive measure of activity and can discriminate between whether a patient is lying, sitting, standing or walking.

Once participants self-report feeling able to start exercising again post-discharge, they will commence the 12 week programme. The intervention will consist of 2 resistance training (RET) sessions per week and 75 minutes of vigorous or 150 minutes of moderate aerobic exercise per week (can be split according to patient preference). They will receive a diary to log their sessions and will be monitored via twice weekly virtual follow-up (either telephone or video calling) and for the first 6 weeks weekly visits to ensure that they are adherent to the exercise protocol and provide any support/advice. Satisfactory compliance with the programme will be considered to be the completion of at least 27 sessions over the 12 week period, with a minimum of 13 out of 18 and 14 out of 18 sessions completed in the first and last 6 weeks, respectively.

The study aims to provide a structured exercise programme to investigate whether a structured exercise programme following discharge from hospital will aid return to full activity. Exercise programmes are a well-tested and effective method of improving fitness in the healthy population. The government guidelines for adults aged 19 and above are to do at least 150 minutes of moderate intensity or 75 minutes of vigorous activity a week which can be split over multiple days. This does not require specialist equipment or costly interventions and include simple measures such as brisk walks and lifting weights. In conjunction with set resistance exercises, the investigators aim to use this as the target to provide a regimen that reaches this target for patients. Physical activity will also be measured at four timepoints during the study using a non-invasive physical activity monitor (ActivPAL) to compare between the intervention and control group.

Recruitment Understandably for the potential recruits this will be a difficult and emotional time period given their significant diagnosis that will have been given very soon prior to the research team's first interaction with them. Participants will be recruited in the outpatient setting but after the diagnosis and treatment plan has been made and conveyed by their parent team. Patients will be given all the information and at least 48 hours to consider their involvement in the study. They will then be re-contacted them via telephone and if they agree, researchers who are trained in taking consent will complete the consent process with the patient. No patients will be included who lack capacity or are in any other way unable to give informed consent. The research group have previously recruited for several prehabilitation studies in this way with good patient feedback and no reports of psychological harm.

Exercise

These guidelines are suitable for older participants with necessary adaptations. However, it is assumed that a small number older of participants may struggle to achieve these targets as they were not achievable for them prior to diagnosis and surgery. The investigators have a long and safe track record of exercise in the elderly in studies performed by the group, and clinical researchers will closely supervise the CPET. Unfamiliarity with exercise in itself is not a reason for non-inclusion in the study, but a more graduated increase in effort may be required for individual participants. There are clear inclusion and exclusion criteria outlined to minimise the risk of adverse outcomes following exercise in the participants. Cardiopulmonary exercise testing (CPET) will be included in the functional assessments at four points during the study. There is a theoretical risk of exercise-induced pathology that may occur secondary to this. The guidelines will be followed for absolute contraindications as laid out by the POETTS consensus guidelines (2018) and ATS/ACCP statement on CPET (2003). These include but are not limited to:

* Acute myocardial infarction (3-5 days)
* Unstable angina
* Uncontrolled arrhythmias causing symptoms or hemodynamic compromise (200 mm Hg systolic, 120 mm Hg diastolic)
* Syncope
* Active endocarditis
* Acute myocarditis or pericarditis
* Symptomatic severe aortic stenosis
* Uncontrolled heart failure
* Acute pulmonary embolus or pulmonary infarction
* Thrombosis of lower extremities
* Suspected dissecting aneurysm
* Uncontrolled asthma
* Pulmonary edema
* Room air desaturation at rest
* Respiratory failure
* Acute non cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
* Mental impairment leading to inability to cooperate These patients will not be included in the study. Also, any abnormal results picked up at screening will warrant exclusion from the study, and the PI will communicate these to the participants' GP.

If any of the following occur both during exercise or CPET testing the programme will be terminated immediately and the participant withdrawn:

* Chest pain suggestive of ischaemia
* Ischemic ECG changes
* Complex ectopy
* Second or third degree heart block
* Fall in systolic pressure 20 mm Hg from the highest value during the test
* Hypertension (250 mm Hg systolic; 120 mm Hg diastolic)
* Severe desaturation: SpO2 ≤ 80% when accompanied by symptoms and signs of severe hypoxemia
* Sudden pallor
* Loss of coordination
* Mental confusion
* Dizziness or faintness
* Signs of respiratory failure CPET testing is the standard test for qualification of lack of cardiorespiratory fitness before operation and is used to stratify risk in higher risk patients as standard of care in the UK.

These guidelines will also be applied to those performing alternative forms of exercise such as brisk walking/running and resistance exercises. The resistance exercise component will via the use of resistance bands and therefore does not require equipment such as weight machines or free weights which can cause injury if applied incorrectly.

Those who volunteer for the study may be more active by virtue of a desire to be included. There is the potential for outcomes not being as generalizable to the whole population regardless of pre-existing physical activity, and also, impact of interventions may be lessened as both groups may be more fit than some groups of those who present for surgery.

Single centre randomised controlled trial

Randomization will occur using www.sealedenvelope.com. This will be performed by a member of the research team on the patient's first visit. Patients will not be blinded due to the active nature of the intervention. Any independent review performed of data will be done by a researcher who has been blinded to group allocation.

All possible analysis will be done in a single blinded manner (e.g., analysis of ultrasound scans, CPET, blood samples etc).

Supervised Exercise for Post-surgery Colorectal Cancer Patients

A Randomised Controlled Trial to Assess the Efficacy of a Postoperative Supervised Exercise Programme in Patients Who Have Undergone Elective Curative Surgery for Colorectal Cancer.

To achieve a significant increase in anaerobic threshold (AT) on CPET (above 2.26ml/kg/min) in a cohort of colorectal cancer patients who have undergone surgery with curative intent following a 12-week combined aerobic and resistance exercise program compared to control.

To assess the feasibility of a twelve-week period of supervised exercise with a home-based component in this cohort of patients after surgery for colorectal cancer.

To assess whether patients feel any emotional/qualitative benefit from a period of supervised exercise in order to help them return to their normal activities of daily living more quickly/at all. The questionnaires employed will be the DASI, EORTC QLQ C30 and IPAQ.

Using muscle ultrasound, measure any changes seen during the study with the application of a supervised postoperative exercise program compared to control (normal postoperative care).

Capture any changes seen during the study via venepuncture in the inflammatory markers with the application of a supervised postoperative exercise program compared to control (normal postoperative care).

University Hospitals of Derby and Burton NHS Foundation Trust

University of Nottingham

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

This is a cross-sectional pilot study of long-term survivors of HPV-related oropharyngeal cancer treated with CTRT who are at least three years from treatment completion. This study consists of a onetime assessment of cardiopulmonary fitness, physical function status, measurement of lean body mass, endothelial function quality of life assessment, medical history and blood laboratory evaluation for traditional cardiac risk factors, endocrine derangement and inflammation.

blood draw

study questionnaire

cardiopulmonary exercise testing (CPET)

DXA (dual-energy x-ray absorptiometry) scan

Shrujal Baxi, MD, MPH

This study is being done to learn about how the participants lungs and heart are working after treatment for throat cancer. The investigators are looking to see if there is a long-term impact on overall health from the cancer treatment. The long-term goal of this study is to compare the participants overall quality of life to similarly aged people who have not had throat cancer.

The goal of this study is not to test the impact of a specific intervention, but rather to evaluate the long-term cardiovascular health and quality of life of oropharyngeal cancer survivors using validated survey instruments, cardiopulmonary testing, and measurements of cardiac risk factors. Thus, no intervention, other than the assessments will be administered as part of the protocol. All participants will have received treatment according to the standard of care or a therapeutic clinical trial in which they may have participated previously. We will collect information about prior treatment from the electronic medical record (EMR).

Cardiopulmonary Fitness in Long-Term Survivors of HPV-related Oropharynx Cancers

Pilot Study of Cardiopulmonary Fitness in Long-Term Survivors of HPV-related Oropharynx Cancers

Memorial Sloan Kettering Cancer Center

Pelvic Neoplasms

Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.

Anh Q Dang, MD

MD Anderson General Health Specialist

Anh Dang, MD

To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery.

In this proposed study researchers will:

1. Measure preoperative energy reserve capacity (fitness)
2. Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism

Primary Objective:

• To characterize the effects of neoadjuvant therapy (chemotherapy, radiation therapy, and/or immunotherapy) on functional capacity in esophageal and lung cancer participants as measured by gas exchange parameters (%predicted AT, %predicted P-VO2, VO2 at AT \& peak exercise, oxygen pulse, ΔVO2/ΔWR, ΔVE/ΔVCO2) obtained from CPET before and after neoadjuvant therapy.

Secondary Objectives:

• To characterize changes in CPET measures in participants treated with chemotherapy, radiation therapy, and/or immunotherapy followed by surgery and correlate these changes with postoperative outcome.

A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes

Measure preoperative energy reserve capacity (fitness) using perioperative energy dynamics where fitness is defined by gas exchange data during cardiopulmonary exercise testing as method of assessing perioperative risk

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum	NCT01719562	Cardiac Toxicit... Malignant Neopl... Breast Cancer	Magnetic resona... Physical Activi... Healthy Living Cardiopulmonary... Questionnaire A...	18 Years - 85 Years	Wake Forest University Health Sciences
MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum	NCT01719562	Cardiac Toxicit... Malignant Neopl... Breast Cancer	Magnetic resona... Physical Activi... Healthy Living Cardiopulmonary... Questionnaire A...	18 Years - 85 Years	Wake Forest University Health Sciences
Supervised Exercise for Post-surgery Colorectal Cancer Patients	NCT05090215	Colorectal Canc... Colorectal Neop...	Aerobic and res... Venous blood sa... Muscle Ultrasou... Cardiopulmonary... Quality of life...	18 Years -	University of Nottingham
Cardiopulmonary Fitness in Long-Term Survivors of HPV-related Oropharynx Cancers	NCT02628912	Oropharynx Canc...	blood draw study questionn... cardiopulmonary... DXA (dual-energ...	18 Years -	Memorial Sloan Kettering Cancer Center
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes	NCT00493688	Abdominal Cance... Pelvic Cancer	Cardiopulmonary...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for cardiopulmonary exercise testing (cpet)