Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Rare Diseases

Breast Neoplasms

Cardiotoxicity

Breast Diseases

Skin Diseases

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Doxorubicin

Liposomal doxorubicin

Patients will perform an acute bout of exercise (different types of exercise for each cycle of anthracyclines) 24-48 hours prior to each cycle of anthracyclines.

Patients will receive standard treatment for each type of tumor proposed by the hospital. This group of patients will be provided with the international recommendations on physical exercise for cancer patients.

Patients will perform an acute bout of exercise (different types of exercise for each cycle of anthracyclines, as aerobic exercise, strength training or combined training) 24-48 hours prior to each cycle of anthracyclines.

Acute Exercise

María Alonso

María Fernández Abad

Cardiotoxicity is one of the most significant adverse effects in breast cancer patients treated with anthracyclines (a type of chemotherapy), so we propose to determine whether acute training (i.e., 24h before each chemotherapy session) could reduce the levels of a cardiac biomarker which measures muscle damage (NT-proBNP).

Given the fact NT-proBNP attenuation has been observed with one session performed 24h before the first treatment, we propose to verify these findings in each cycle of doxorubicin analyzing how each type of exercise (aerobic, strength or combined aerobic + strength) may impact on anthracycline-induced cardiotoxicity, since this observation may be relevant considering the feasibility and low cost this implementation would represent in clinical practice.

Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

Assesed using the validated EORTC-QLQ-C30 quality of life questionnaire

Assesed using the validated Functional Assessment of Cancer Therapy: Fatigue (FACT-F)

Assesed using the validated International Physical Activity Questionnaire (IPAQ-SF)

Assesed using the Timed Up and Go (TUG) test

Assesed using the hand grip dynamometer test

Biomarker of cardiac injury value in blood tests

Resting blood pressure assesed by sphyngomanometer

Change in left ventricular systolic function quantified by transthoracic echocardiography

Technical University of Madrid

PhD Physical Activity and Health

Blood and Lymph Conditions

Lymphedema

Breast Cancer Lymphedema

Lymphatic Diseases

Postoperative Complications

The intervention group will receive a total of 24 sessions of Therapeutic Resistance Exercise, distributed in 2 weekly sessions of 50 minutes during 3 months.

The control group will receive an educational booklet containing generalized mobility exercises such as frontal and lateral shoulder raises and rotations (hands to head, hands behind back). This is usually the usual treatment, since in most centers, patients are only referred for treatment of LACM when it is already established.

Strength exercises will be aimed at large muscle groups, such as the shoulder, chest, back and also muscle groups of the lower extremities. In the initial 2 weeks, intervention will start with low intensities of around 55-65% of 1RM, which allows to perform around 15-20 repetitions. The first week there will be performed 2 series, while in the second week it will be 3 series.

Moderate intensity in the 2nd week, corresponding to 65-75% of 1RM and allowing for around 8-12 repetitions. 3 series will be maintained throughout this period of time.In addition to the progressive change in intensity, throughout the intervention the load will be increased by 5-10% when the patient performs the exercise too easily or when they can perform more repetitions than estimated. Rest between sets will be 2-3 minutes.

Resistance Therapeutic Exercise

Cristina Roldán-Jiménez, PhD

The objective of this study is 1) to study the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using variables related to the lymphatic response; 2) Study the possible relationship between changes in body composition at a local and regional level and volume changes produced by RTPE in patients at risk of suffering from BCRL.

Nowadays, research studies that confirm the safety and preventive effect of resistance or strength exercise in breast cancer-related lymphedema (BCRL) have been limited to the study of changes in variables related to the lymphatic response, such as bioimpedance spectroscopy , X-ray absorptiometry, perometry or water displacement after completion of a resistance exercise program (chronic effect).

To better understand the preventive effect of resistance exercise on the BCRL, in addition to studying the variables that are globally accepted and studied at a regional level such as the volume due to water displacement, variables that measure changes at a regional level related to body composition, such as such as echogenicity and ultrasound thickness, local tissue water and mechanical properties of tissues. Furthermore, this would allow us to detect possible changes in different body regions of the upper quadrant (upper extremity, but also breast or back), and not only taking global changes into account. On the other hand, the lymphatic response should be studied in the short term (acute effect), in the long term after an exercise program (chronic effect), as well as in the short term after the training period with possible adaptations to the lymphatic system that could explain the preventive effect.

Therefore, although there is a strong degree of scientific evidence to include therapeutic strength physical exercise as a preventive tool for LACM, the possible physiological mechanisms involved are unknown. The aim of the present project is to tudy the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using regional but also local variables related to the lymphatic response, as well as to study between changes in these variables, body composition at a local and regional level and volume changes produced by RTPE in breast cancer survivors at risk of suffering from BCRL

Blinding of the researchers in charge of the evaluations and data analysis will be implemented, so that they are unaware of the assignment of each patient to the groups. It is not possible to blind participants and the physiotherapist (care provider) due to the very nature of the intervention

Lymphatic Response to Resistance Exercise in Breast Cancer Survivors

Prevention-Related Lymphatic Response to Resistance Exercise in Breast Cancer Survivors at Risk of Breast Cancer-Related Lymphedema

The volume of both extremities will be measured to obtain the difference between both, which will be used as a relative criterion to determine the preventive effect of the intervention, determining the appearance of LACM as those cases in which the patient reaches a difference after one year of follow-up. volume equal to or greater than 10% between both extremities. It will be measured using water displacement volumetry, considered the gold standard for measuring the volume of the affected limb.

The EFC of the affected and contralateral side (liters, l) will be obtained. Which will allow establishing the ECF radius between the extremities. This ratios will be allowed to estimate L-Dex. The L-Dex ratio ranges between -10 and +10, taking into account the ratio between the dominant and non-dominant arms, which is equivalent to impedance ratios of 0.935 to 1.139 for the dominant arms at risk and from 0.862 to 1.066 for non-dominant arms at risk, respectively. It will be obtained through bioimpedance spectroscopy

Local tissue water will be measured by bilateral tissue dielectric constant (TDC). values on the forearm and biceps using the MoistureMeterD Compact. PWC%= 100%x(TDC-1)/77.5. It will be measured on the anterior and posterior aspects of the arm and forearm, on the breast, on the lateral aspect of the shoulder and in the dorsal area.

It will be obtained through the analysis of ultrasound images. The thickness will be measured in millimeters (mm). It will be measured on the anterior and posterior aspects of the arm and forearm, on the breast, on the lateral aspect of the shoulder and in the dorsal area.

It will be obtained through the analysis of ultrasound images. Echogenicity or echointensity refers to the average value obtained from a histogram generated from an 8-bit gray scale. This analysis does not have units of measurement, but provides a numerical value between 0 and 255. It will be measured on the anterior and posterior aspects of the arm and forearm, on the breast, on the lateral aspect of the shoulder and in the dorsal area.

It will be measured with a MyotonPRO portable device (Myoton AS, Estonia), whose probe will be placed on the surface of the skin and produce a mechanical stimulus that will provide five parameters: Tone (Hz), Dynamic stiffness (N/m), Elasticity (unit relative), Relaxation time (ms) and Fluency (relative unit). It will be measured on the anterior and posterior aspects of the arm and forearm, on the breast, on the lateral aspect of the shoulder and in the dorsal area.

it will be measured using the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire (EORTC QLQ-BR23). This is an EORTC QLQ-C30 breast cancer module that contains 23 items that assess disease symptoms, treatment side effects, body image, sexual functioning, and future outlook. All items are rated on a 4-point scale (1, not at all to very much). Higher scores represent better functioning and higher symptom scores show greater problems. Cronbach's α ranged from 0.46 to 0.94, showing high reliability.

Abduction and flexion of the shoulder joint complex will be measured. It will be measured in a sitting position, ensuring that there is no movement of the trunk, using a digital inclinometer.

It will be measured using the Jamar Hydraulic Hand dynamometer. All participants will sit in a chair without armrests, with their feet on the floor and their back straight, holding the dynamometer with their dominant arm. The elbow was flexed at 90° and the wrist was in a neutral position (0°). Maximum isometric voluntary contractions will be performed for 5 seconds. The force will be expressed in kg. Of the 3 measurements carried out, the peak force will be recorded in units of Newtons (N) or in Kilograms (Kg), obtained from both extremities

It will be measured using the Shoulder Pain and Disability Index (SPADI) questionnaire. SPADI consists of 13 items that are distributed in two different subscales: one related to pain, which contains 5 items, and another related to disability, which contains 8 items. Scoring of items in both subscales is on a scale ranging from 0 (indicating absence of pain or disability) to 10 (representing the worst pain imaginable or such significant difficulty in performing tasks that help is needed). The higher the score on each subscale, the greater the pain intensity and the greater the disability experienced by the individual evaluated.

It will be measured using the Spanish version of the Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) questionnaire.This questionnaire consists of 2 parts: Part 1 is made up of 24 items and evaluates the symptoms of LACM using a Likert scale from 0 (absence of a certain symptom) to 4 (greater severity of a certain symptom); Part 2 is made up of 32 items that evaluate the symptom of discomfort, that is, the negative impact and suffering evoked by the experience of lymphedema. Each part is calculated with the sum of all the responses, and in turn they can be added together to obtain a total score

It will be measured using the Spanish version of Fear-Avoidance component scale (FACS). The FACS contains 20 separate items that are scored from 0 ("completely disagree") to 5 ("completely agree"), with a total possible score of 100. Five severity levels are available for clinical interpretation: subclinical (0-20), mild (21-40), moderate (41-60), severe (61-80), and ex- treme (81-100). This questionnaire has been validated in breast cancer population, showing good psychometric properties.

University of Malaga

Profesor and Reseacher (PT, PhD)

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Immunomodulating Agents

Patient randomized to the Exercise arm will receive physical activity recommendations at inclusion and nutritional assessment will be carried out during the first and last treatment cure. Patients will receive an acute physical exercise just before immunotherapy and chemotherapy infusion.They will have a home walking program and will have to wear an activity tracker during the 3 months of intervention.

3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place before exercise (1), after exercise (2) and 12 hours after the start of treatment (3).

Patients will receive physical activity recommendations at inclusion and a nutritional assessment will be carried out during the first and last treatment cure. They will receive the usual care and standard treatment protocol (immunotherapy and chemotherapy).

3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment (3).

Patients will receive physical activity recommendations at inclusion.

At each treatment cure, patients will receive pre-exercise nutritional recommendations and an acute physical exercise prior to immunotherapy and chemotherapy. The acute physical exercise will last 35 minutes and will be intermittent and individualized based on the results obtained by the patient during an endurance test on a ergocyle performed prior to treatment.

3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place before exercise (1), after exercise (2) and 12 hours after the start of treatment (3).

A nutritional assessment will be carried out during the first and last treatment cure.

They will also benefit a home walking program. These patients will have to wear an activity tracker tracker during all intervention (3 months).

They will have a phone follow-up every 10 days (± 3 days) after each treatment cure for the study duration.

Exercise arm :

Maurice Pérol, MD

Because of metastatic Non-Small Cell Lung Cancer (mNSCLC) and its treatments, patients suffer from numerous symptoms such as dyspnea, muscle atrophy, pain, fatigue, loss of appetite, altered physical condition and lung function, which may further impair the patient's overall condition. Nevertheless, it has been suggested that physical exercise could improve response to treatment at the clinical level due to its known effects on the immune system. Moreover, preclinical studies have shown that exercise performed during chemotherapy administration could result in physiological benefits such as improved intra-tumoral infusion and drug delivery. The ERICA study aims to assess the feasibility of an acute physical exercise immediately before immunotherapy and chemotherapy administration in patients with mNSCLC.

Feasibility of an Acute Physical Exercise Before Treatment Infusion for Metastatic Lung Cancer Patients

Feasibility of an Acute Physical Exercise Before Immunotherapy and Chemotherapy Infusion for Metastatic Non-small-cell Lung Cancer Patients: Protocol ERICA Study

Ratio of the number of acute physical exercise sessions immunotherapy/chemotherapy preinfusion performed by"exercise" group patient / number of acute physical exercise sessions planned

Sub-maximum endurance test on an ergocycle

Maximum isometric force of the knee extensors

The PA level will be measured by the Godin Leisure-Time Physical Activity Questionnaire (GLTAPQ). The GLTAPQ is a 4-item self-administered questionnaire with the first three questions designed to obtain information on the number of times an individual engages in light, moderate and intense "leisure-time PA" periods of at least 15 minutes during a typical week. The scoring of the GSLTPAQ is the "LSI" (Leisure Score Index) is obtained using the following formula: (light PA frequency × 3) + (moderate PA frequency × 5) + (vigorous PA frequency × 9). People with a moderate to high LSI ≥ 24 are classified as active, while people reporting a moderate to high LSI ≤ 23 are classified as insufficiently active (estimated energy expenditure \< 14 Kcal/kg/week).

Quality of life will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). Quality of life specific to lung cancer will be assessed by the 13-item module: The Quality Of Life Questionnaire - Lung Cancer 13 (QLQ-LC13). The QLQ-LC13 self-questionnaire is an additional measure of the symptoms and side effects experienced by lung cancer patients who receive non-surgical treatment.

Quality of life specific to lung cancer will be assessed by the 13-item module: The Quality Of Life Questionnaire - Lung Cancer 13 (QLQ-LC13). The QLQ-LC13 self-questionnaire is an additional measure of the symptoms and side effects experienced by lung cancer patients who receive non-surgical treatment.

Fatigue will be assessed by the EORTC-QLQ module measuring cancer-related fatigue (EORTC QLQ-FA12). This self-questionnaire includes 12 items that assess physical, cognitive and emotional fatigue related to cancer. Participants will respond on a Likert scale ranging from "not at all" to "a lot". All scores will be transformed into a scale from 0 to 100, with a higher score indicating a higher degree of fatigue.

The perceived quality of sleep is assessed by the Insomnia Severity Index (ISI) which measures the severity of insomnia. The questionnaire consists of 7 items rated on a 5-point scale ranging from 0 ("none") to 4 ("very severe"). This self-questionnaire makes it possible to evaluate the severity of the patient's sleep difficulties (initial, maintenance, morning insomnia), the degree of sleep dissatisfaction, the level of interference with daily functioning, the degree of appearance of sleep difficulties and the level of anxiety related to insomnia. The total score of the items varies between 0 and 28. A high score indicates greater sleep difficulties.

Social vulnerability will be assessed by the EPICES score (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé). By adding up the points of the 11 binary questions ("Yes"/"No") of the self-questionnaire we obtain the so-called EPICES score. This quantitative score varies from 0 "no precariousness" to 100 "highest precariousness".

3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).

The following immune biomarkers will be assay : Natural Killer cells, B lymphocytes, T lymphocytes, monocytes, sub-populations of dendritic cells on frozen PBMC

3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).

3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).

The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).

Occurence of severe toxicity (grade \> 2) according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Number of delayed or cancelled treatment sessions and relative dose-intensity (RDI) for patients with grade ≥ 3 chemotherapy-related toxicities, calculated as the ratio of the "delivered" dose-intensity to the "expected" dose-intensity.

Period from the date of randomization to the date of event defined as disease progression or death from any cause

Ratio of the number of patients included / number of eligible patients

Number of days the activity tracker is worn / number of days in the programme

Number, type and timing of adverse events due to program

number of steps at home realized / number of steps at home prescribed (only in the intervention arm)

Daily number of step prescription (only in the intervention arm)

Claude Bernard University

Lyon Cancer Research Centre

Hospices Civils de Lyon

Inter-university Laboratory of Human Movement Biology

Centre Leon Berard

Participants will be asked to walk or jog on a treadmill for a maximal exercise test.

Kathleen Sturgeon, PhD, MEd, MS

The primary aim is to examine changes in tumor perfusion, oxygen saturation, and tumor physiology before and following acute physical activity in breast cancer patients.

The secondary aim is to examine changes in circulating tumor DNA (ctDNA) levels before and following acute physical activity in breast cancer patients.

The tertiary aim is to explore changes in circulating exerkines (cytokines and growth factors altered by exercise) before and following acute physical activity in breast cancer patients.

The proposed study seeks to leverage acute exercise physiology as a tool to better understand multiple clinical and mechanistic issues in exercise oncology. An acute exercise bout causes functional changes such as increases in heart rate and stroke volume leading to increased cardiac output and increased systemic blood flow. These systemic effects also increase tumor blood flow (perfusion). Additionally, an increase in mean arterial pressure increases oxygen diffusion distance within the tumor. Further, acute exercise mobilizes NK cells, cytokine signaling, and a myriad of other molecular and cellular transducers of exercise. Our study of acute exercise physiology in breast cancer patients will address several significant knowledge gaps both clinically and mechanistically.

Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology

Total hemoglobin will be quantified using photoacoustic imaging and the % difference will be determined 1) before cardiopulmonary exercise (CPET) (Time 0), 2) immediately after CPET (Time 1), 3) 30 min after CPET (Time 2) , and 4) 2 hours after CPET (Time 3).

Oxy-hemoglobin will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

Deoxy-hemoglobin will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

Oxygen saturation will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

ctDNA level will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

TGF-β will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

VEGF-A will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

S1P will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

TSP-1 will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cardioprotective Effect of Acute Exercise in Breast Cancer Patients	NCT05467111	Early-stage Bre...	Acute Exercise	18 Years -	Technical University of Madrid
Lymphatic Response to Resistance Exercise in Breast Cancer Survivors	NCT06113627	Breast Cancer L... Survivorship Lymphedema of U...	Resistance Ther...	18 Years -	University of Malaga
Feasibility of an Acute Physical Exercise Before Treatment Infusion for Metastatic Lung Cancer Patients	NCT04676009	Carcinoma, Non-...	Exercise arm :	18 Years - 80 Years	Centre Leon Berard
Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology	NCT05428709	Breast Cancer	Acute Exercise	18 Years - 80 Years	Milton S. Hershey Medical Center

Spots Global Cancer Trial Database for acute exercise