Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Pathologic Complete Response

Breast Diseases

Skin Diseases

The control group will receive neoadjuvant chemotherapy alone (standard of care).

The experimental group will receive neoadjuvant chemotherapy (standard of care) in conjunction with an exercise intervention. The exercise intervention will be implemented concurrently for the full duration of the neoadjuvant chemotherapy treatment.

Apart from the neoadjuvant chemotherapy treatment (standard of care), participants allocated to the experimental group will additionally participate in a supervised physical exercise program that comprises 3 weekly sessions during the months that the patient is undergoing chemotherapy treatment. Each 75-minute session will comprise a 10-minute warm up, 30 minutes of strength training involving exercise for the major muscle groups, 30 minutes of aerobic training at 40-89% of heart rate reserve and a 5-minute cool down.

Combined Aerobic and Resistance Exercise

Nuno D Rato, MSc

Alberto Alves, PhD

Nuno Rato, MSc

One of the recommended treatments for breast cancer is neoadjuvant chemotherapy (NCT), however, only 20% of the patients subject to this therapy present pathologic complete response (pCR). If exercise-induced tumour size reductions observed in preclinical studies translates to humans, physical training could emerge as a way of increasing rates of pCR to NCT, which would be a valuable clinical achievement. The present randomized controlled trial primary aim is to assess the impact of a physical exercise intervention the NCT efficacy. Following a parallel-arm design, 86 women with primary BC will be allocated 1:1 to a NCT + exercise (experimental) or NCT alone (control) group. The primary outcome is the rate of pCR in each group. Secondary outcomes include treatment tolerability and compliance, tumour infiltrating lymphocytes, ki67, immune, inflammatory, matricellular and myogenic markers, physical fitness, accelerometry, quality of life and body composition.

Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients

Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients - The KEYMOVE Randomized Controlled Trial

Pathological response as the primary outcome will be assessed by a blinded pathologist from the tumour surgical specimens after the breast surgery (post-intervention) and will be defined as complete, partial or no response. Besides pathological complete response (defined as ypT0/ypN0), groups will be compared as those with response (complete or partial) versus those with no response. The residual cancer burden which quantifies residual disease after NAC (post-intervention) will also be assessed.

Number of participants with clinically assessed treatment-related adverse events. Will be assessed according to the Common Terminology Criteria for Adverse Events v5.0. The scale uses a minimal value of 1 and a maximal value of 5 to grade each adverse event, with higher scores representing worse outcomes.

Number of participants with patient-reported adverse events. Will be assessed using the Patient reported outcomes version of the Common Terminology Criteria for Adverse Events v1.0 questionnaire. The scale uses a minimal rating 0 and a maximal rating of 4 to grade each adverse event, with higher scores representing worse outcomes.

Chemotherapy relative dose intensity will be calculated by the following formula: (Delivered dose intensity / Standard dose intensity) x 100%, where Delivered dose intensity = (Delivered total dose, in mg/m2)/(actual time to complete chemotherapy with imputation for missed cycles, in days) and Standard Dose Intensity = (Standard total dose, in mg/m2)/(standard time to complete chemotherapy, in days).

Number of patients that had to reduce the dose of chemotherapy from the dose of chemotherapy initially prescribed (standard dose intensity).

Number of patients that had to delay a cycle of chemotherapy, in comparison to what had initially been prescribed (standard dose intensity).

Number of patients that had to interrupt chemotherapy before the standard dose had been administrated.

Assessed at Histology Slides. Intratumoral and stromal infiltrating lymphocyte (TIL) population will be assessed in tumour biopsies (at baseline) and surgical resection specimens collected from the post-neoadjuvant chemotherapy surgery (post-intervention). This will be used to compute intratumoral and stromal TIL's score, recorded as the percentage of TIL's on the analysed area. Only stromal TIL ́s will be quantified in patients with complete pathological response.

Assessed at Histology Slides. Ki67 will be assessed in tumour biopsies (at baseline) and surgical resection specimens collected from the post-neoadjuvant chemotherapy surgery (post-intervention).

Flow cytometry will be the method used to assess the number of CD3+CD8+ (cytotoxic T cells) on peripheral blood lymphocytes.

Flow cytometry will be the method used to assess the number of CD3+CD56+ (natural killer T cells) on peripheral blood lymphocytes.

Flow cytometry will be the method used to assess the number of CD3+CD4+ (T helper cells) on peripheral blood lymphocytes.

The enzyme-linked immunosorbent assay method will be used to identify the concentration of the cytokine IFN-gamma on plasma.

The enzyme-linked immunosorbent assay method will be used to identify the concentration of the cytokine TNF-alpha on plasma.

The enzyme-linked immunosorbent assay method will be used to identify the concentration of the hormone Irisin on plasma.

The enzyme-linked immunosorbent assay method will be used to identify the concentration of the protein SPARC on plasma.

The enzyme-linked immunosorbent assay method will be used to identify the concentration of the protein Decorin on plasma.

The enzyme-linked immunosorbent assay method will be used to identify the concentration of the cytokine Oncostatin-M on plasma.

As an indicator of cardiorespiratory fitness, the number of meters that the participant is able to walk/run in the 10 meter-incremental shuttle walk test will be assessed.

The participant will be subjected to a maximal incremental conventional cardiopulmonary exercise test on a treadmill. The maximal intensity the participant is able to attain in this assessment will be recorded in METS.

The 30 second sit-to-stand test will be used to assess lower limb dynamic muscular strength. The maximal number of repetitions the participant is able to perform in the 30 second sit-to-stand test will be recorded.

The maximal force (in kilograms) the participant is able to produce in an isometric handgrip test will be recorded, using a hand dynamometer.

The maximal force (in kilograms) the participant is able to produce in an isometric strength test for the quadriceps muscle will be recorded using a load cell. Additionally, the time to maximal strength (in seconds) will also be recorded.

Assessed by accelerometry over a period of seven days, the time (in minutes) that the participants spend in light, moderate and vigorous physical activity will be recorded. Additionally, the time (in minutes) spent in sedentary behaviours will also be recorded.

The questionnaires European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (version 1.0) and the Breast 23 Questionnaire (version 1.0) will be implemented to assess cancer-related quality of life. The final scores will range from 0 to 100, with higher scores on the functional scales representing a high level of functioning and higher scores on the symptom scales implying a stronger symptom burden.

Using bioimpedance, the participants' total body weight, in kilograms, will be assessed with the lightest clothes possible.

Using bioimpedance, the participants' total body skeletal muscle mass, in kilograms, will be assessed.

Using bioimpedance, the participants' total body fat, in kilograms, will be assessed.

Using weight and height, these parameters will be combined to report BMI in kg/m\^2.

Aveiro University

Centro Hospitalar de Vila Nova de Gaia/Espinho

Associacao de Investigacao de Cuidados de Suporte em Oncologia

University of Maia

University Institute of Maia

Principal Investigator

Nutritional and Metabolic Diseases

Overweight

Obesity

Overnutrition

Nutrition Disorders

Body Weight

12 weeks of supervised resistance exercise and unsupervised aerobic exercise.

The 12-week intervention will build upon an ongoing resistance exercise program for cancer patients and survivors at the University of Colorado's Anschutz Health and Wellness Center. Resistance exercise will be led by certified cancer exercise specialists who provide individualized exercise programs to cancer patients and survivors. Exercise sessions are progressive, target all major muscle groups, are 50 minutes in duration, and completed 2x/week.

The intervention will also include 3 self-directed moderate-intensity aerobic exercise sessions/week, building to 50 minutes at 60% heart rate maximum (determined at baseline). Target exercise will be achieved by a gradual progression of exercise duration over the first four weeks of the program.

Combined aerobic and resistance exercise

The overall aim of this research is to assess the feasibility of a 12-week combined aerobic exercise (AEx) and resistance exercise (REx) intervention and elucidate the impact of AEx/REx on several physiological and behavioral components of energy balance among breast cancer survivors (BCS).

Masking is not possible because this is a single-arm exercise study.

Combined Modality Exercise and Appetite in Breast Cancer Survivors

Feasibility, Acceptability, and Effects of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors: A Pilot Study (the CARE Study)

Resting energy expenditure measured by metabolic cart and adjusted for body composition changes

Fat mass and fat-free mass in kg, measured by dual X-ray absorptiometry

Measured by the Functional Assessment of Chronic Illness and Therapy - Fatigue; 13 questions; score range: 0-52, with higher score indicating higher fatigue

Number of individuals approached, meeting inclusion criteria, reasons for exclusion, and enrolled in the study

Participants will be asked to rate on a 1-10 Likert scale: 1) how adherent they were to the prescribed exercise over the past week, 2) how difficult it was to adhere to the prescribed exercise over the past week, and 3) how likely they feel they can adhere to the prescribed exercise for the next month.

Self Efficacy for Exercise Scale; 9 items; score range: 0-9, with higher scores indicating higher exercise self-efficacy

Physical Activity Enjoyment Scale; 8 items; range: 7-56, with higher scores indicating higher exercise enjoyment

Subjective ability to adhere to combined AEx/REx

Open-ended opinions on the structure and content of the exercise training sessions

Changes in subjective physical function, cancer-specific side effects, and overall well-being directly related to the exercise intervention

Adherence to additional study-specific AEx will be tracked through heart rate monitor data, logs of attendance, and participant diaries and compared to the REx-only intervention

Fasting ghrelin, ghrelin area under the curve in response to a control meal

Fasting PYY, PYY area under the curve in response to a control meal

Changes in hunger, satiety, and prospective food consumption via visual analog scales

Time in sedentary activities measured by accelerometers

Colorado Clinical & Translational Sciences Institute

National Cancer Institute (NCI)

University of Colorado, Denver

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Substance Related Disorders

Wounds and Injuries

Rare Diseases

Lymphoma

Cardiotoxicity

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Lymphosarcoma

Aerobic Exercise twice weekly for 5 months.

Combined Aerobic and Resistance Exercise twice weekly for 5 months.

Standard Care, i.e no exercise intervention.

Participants receive twice weekly supervised aerobic treadmill-based exercise sessions for five months. Session duration varies from 20 to 60 minutes, including warm-up, with exercise intensity ranging from 60 to 95% of peak heart rate. Maximal exercise capacity (VO2peak and peak heart rate) will be determined by the CPET performed by certified exercise physiologists at baseline.The exercise prescription will be sequenced so that the exercise intensity and -duration of each exercise varies within each week, leading to an accumulative increase in weekly exercise volume throughout the intervention. This intervention is also given to the Active Comparator group (i.e. non-cancer reference group)

Aerobic Exercise

Twice weekly, supervised combined aerobic and resistance exercise sessions will be offered to participants. Participants randomized to the combined aerobic and resistance training group will follow the same aerobic exercise prescription as described for the Aerobic Exercise arm. In addition, participants in this group will perform five resistance exercises after the aerobic sessions. The resistance exercises will be leg press, knee extension, and calf rise, followed by seated row and chest press. Following familiarization, the training load will progressively increase following a linear periodization model throughout the intervention. exercise prescription will be sequenced so that the exercise intensity and -duration of each exercise varies within each week, leading to an accumulative increase in weekly exercise volume throughout the intervention. Only Lymphoma participants can be randomized to this arm.

Tormod S. Nilsen, PhD

Helena Igelström, PhD

Anna Henriksson, PhD

This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases.

In this study, a comparison of the exercise effects between individuals previously treated for specific lymphoma diagnoses and individuals with no history of cancer will be conducted. Therefore, in addition to a randomized controlled trial in individuals with a previous lymphoma diagnosis (i.e., exercise groups and a non-exercising control group), a reference group comprising age- and sex-matched individuals with no history of a cancer diagnosis will also be included. Participants in the reference group will undergo the same exercise intervention as the aerobic exercise group. This study recruits through invitation only.

The primary endpoint in this study is the change in cardiorespiratory fitness, assessed as VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and cardiometabolic health, other variables derived from the cardiopulmonary exercise test and lung function assessments, and muscle cellular endpoints from muscle biopsies obtained from m. vastus lateralis, in addition to patient-reported outcomes.

Effects of Exercise Training in Survivors of Lymphoma

The LYMfit Study: Exercise Training to Prevent Cardiovascular Disease in Lymphoma Survivors

Will be assessed in Norway only. For a sub-group of participants, muscle biopsies will be further processed for RNA and DNA

Medical records and Patient reported outcome version of the Common Terminology Criteria for Adverse Events.

Peak oxygen uptake during a treadmill-based cardiopulmonary exercise test

Cardiac morphology and function will be assessed by echocardiography (2D and 3D echocardiography and 2D strain echocardiography)

Body composition will be assessed by dual x-ray absorptiometry

Lung function are assessed with spirometry.

Diffusion capacity for carbon monoxide is assessed with single breath diffusion capacity test.

Actigraph accelerometer with physical activity diary. 7 days consecutive measurement at each timepoints.

Patient reported physical activity is assessed with Godin Leisure-Time Exercise Questionnaire

Patient reported health related quality of life will be assessed with EORTC QLQ C 30

Will be assessed in Norway only. Using the carbon monoxide rebreathing method.

Will be assessed in Norway only. Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry

Will be assessed in Norway only. Change in mitochondrial proteins will be assessed in muscle biopsies using western blot

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients	NCT05976815	Breast Cancer	Combined Aerobi...	18 Years -	University Institute of Maia
Combined Modality Exercise and Appetite in Breast Cancer Survivors	NCT04576247	Breast Cancer F... Overweight and ...	Combined aerobi...	18 Years - 45 Years	University of Colorado, Denver
Effects of Exercise Training in Survivors of Lymphoma	NCT06270667	Lymphoma Physical Exerci... Cardiotoxicity Cardiovascular ... Chemotherapeuti...	Aerobic Exercis... Combined Aerobi...	20 Years - 70 Years	Norwegian School of Sport Sciences
Effects of Exercise Training in Survivors of Lymphoma	NCT06270667	Lymphoma Physical Exerci... Cardiotoxicity Cardiovascular ... Chemotherapeuti...	Aerobic Exercis... Combined Aerobi...	20 Years - 70 Years	Norwegian School of Sport Sciences

Spots Global Cancer Trial Database for combined aerobic and resistance exercise