Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Cognitive Dysfunction

Breast Diseases

Skin Diseases

The combine exercise intervention will consist of three 30-minute, supervised, remotely-delivered resistance training classes as well as three 30-minute, unsupervised aerobic training (i.e., walking) items each week. Participants will also participate in bi-weekly, 30-40 minute, remotely-delivered behavioural counselling sessions delivered via videoconferencing (i.e., Zoom). The program will be taught by a Registered Kinesiologist via videoconferencing (i.e., Zoom). Participants will be asked to participate in the intervention for 8 weeks.

The active control group will participate in three 30-minute, supervised, remotely-delivered classes targeting balance and flexibility. The program will be delivered at a low-intensity by a Registered Kinesiologist via videoconferencing (i.e., Zoom). Participants will be asked to participate in the program for 8 weeks.

The combine exercise intervention will consist of three 30-minute, supervised, remotely-delivered resistance training classes as well as three 30-minute, unsupervised aerobic training (i.e., walking) sessions each week. Participants will also participate in bi-weekly, 45-60 minute, remotely-delivered, group-based behavioural counselling sessions delivered via videoconferencing (i.e., Zoom). Participants will be asked to participate in the intervention for 8 weeks.

Combined Exercise + Behavioural Counselling

Active Control

Linda Trinh, PhD

Women living with and beyond breast cancer are at a heightened risk for experiencing adverse mental health outcomes and declines in cognitive function following chemotherapy treatment. Women living with and beyond breast cancer have reported increased levels of anxiety and depression during the COVID-19 pandemic which may have significantly impacted their quality of life (QoL). Physical activity (PA) may be used to manage mental health and improve cognitive function in women living with and beyond breast cancer. Research is needed to assess the feasibility of a supervised, remotely delivered, combined (i.e., aerobic + resistance) exercise program to improve cognitive function and manage adverse mental health in women living with and beyond breast cancer. This study will pilot an 8-week, remotely delivered, combined (i.e., aerobic + resistance) exercise and behavioural counselling intervention on cognitive function and mental health outcomes (i.e.,anxiety, depression, self-efficacy and self esteem) in women living with breast cancer who received chemotherapy treatment within 12-48 months.

Women living with and beyond breast cancer who received chemotherapy treatment are at a heightened risk for experiencing adverse mental health outcomes (i.e., anxiety, depression, self-efficacy and self esteem) and declines in cognitive function (i.e., impairments to memory, learning, concentration, reasoning, executive function, attention, processing speed and/or visual-spatial skills deficits) compared to those without a history of cancer. These effects may be worsened among those who received chemotherapy treatment and may persist for up to 5 and 20 years following chemotherapy treatment completion, respectively. The COVID-19 pandemic has exacerbated existing adversities in the mental health of women living with and beyond breast cancer due to reduced social opportunities, greater sedentary time, fear of susceptibility to the virus and barriers to in-person support services. Physical activity (PA) may be used to manage mental health adversities and improve QoL among women living with and beyond breast cancer. In addition, preliminary evidence has demonstrated the potential mediating effect of PA on cognitive impairments among women living with and beyond breast cancer. Remote-based interventions could be an effective option to increase PA during the COVID-19 pandemic while maintaining physical distancing protocols. In addition, the combination of exercise with group-based counselling has been found to be feasible and provide favourable improvements in depression, self-efficacy, social support, and quality of life and long-term PA maintenance among women living with and beyond breast cancer, compared to exercise interventions alone. However, no studies have evaluated the feasibility and impact of a supervised, remotely delivered, combined (i.e., aerobic and resistance) exercise + behaviour counselling program on mental health and cognitive function in women living with and beyond breast cancer following chemotherapy treatment. Using a mixed-method approach, this study will address these gaps by evaluating the feasibility of a supervised, remotely delivered combined (i.e., aerobic and resistance) exercise and behavioural counselling program for mental health and cognitive function in women living with and beyond breast cancer. This project is necessary given the remote-based format of exercise delivery that has been adopted because of the COVID-19 pandemic and the need for programs to be adapted to an environment that is safe and reliable to deliver to women living with and beyond breast cancer.

Participants will be randomized to one of two conditions: combined exercise (aerobic + resistance training) or stretching/toning (active control). They will receive a home-based program lasting 1 hour on 3 days per week for 12 weeks. Randomization will be performed using a computer-generated program in blocks of four for even distribution between study conditions. BCS will be assigned in a 1:1 ratio to one of two study conditions, stratified by treatment type (anthracycline vs. non-anthracycline chemotherapy; hormonal vs. no hormonal therapy).

The participants will only be aware that the researchers are comparing two exercise conditions and therefore will be blinded to the study hypotheses.

A Combined Exercise Training Program for Women Living With Breast Cancer

A Remotely-Delivered, Combined Exercise Training Program for Cognitive Function in Women Living With and Beyond Breast Cancer: A Feasibility Study

Participant enrolment rate will be one measure of feasibility. This will be calculated by measuring the amount of participants who enrolled in the intervention, divided by the number of participants who were assessed for eligibility.

Adherence rate of participants to the intervention, will be one measure of feasibility. This will be measured by calculating the number of exercise sessions participants attend, divided by the total number of exercise sessions that took place in the intervention.

Attrition will be one measure of feasibility. This will be measured by calculating the number of participants who did not complete the intervention, divided by the number of participants who completed the entirety of the intervention

Burden and satisfaction scores will be one measure of feasibility. This will be assessed using a researcher-generated 15-item questionnaire that asks participants about their experience with the intervention and assessments. Participants will rate items using a 5-point Likert scale (1= 'strongly disagree', 5 = 'strongly agree').

Adverse events will be one measure of feasibility. This will be assessed as an unexpected and severe medical problem or injury that occurs during the exercise classes.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Flanker Inhibitory Control and Attention Test tests the ability to inhibit visual attention to irrelevant task dimensions. A scoring algorithm integrates accuracy and reaction time yielding scores from 0 to 10. There are 40 trials and the average time to complete the task is 4 minutes.To interpret individual performance, one can evaluate all three types of scale scores in which higher scores indicate higher levels of ability to attend to relevant stimuli and inhibit attention from irrelevant stimuli.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Picture Sequence Memory Test involves a presentation of stimuli which are pictured objects and activities, thematically related but with no inherent order. For each trial, pictures appear in the center of the screen and then are moved 1 at a time into a fixed spatial order, as an audio file simultaneously describes the content of each. The score is based on the cumulative number of adjacent pairs of pictures remembered correctly over 3 learning trials. The test takes approximately 10 minutes. Higher scores indicate better episodic memory.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Picture Vocabulary Test involves single words that are presented via an audio file, paired simultaneously with 4 screen images of objects, actions, and/or depictions of concepts. The participant will pick the picture that matches the spoken word. Total administration time is approximately 5 minutes. To interpret individual performance, one can evaluate all three types of scale scores. A participant's age-adjusted scale score at or near 100 indicates vocabulary ability that is average for the age level. Scores around 115 suggest above-average vocabulary ability, while scores around 130 suggest superior ability - in the top 2 percent nationally for age, based on Toolbox normative data.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). This composite includes the Picture Vocabulary and Reading Tests. This composite score is derived by averaging the normalized scores of each of the measures, and then deriving scale scores based on this 14 new distribution. An Age-Adjusted Scale Score, Fully Adjusted Scale Score, Unadjusted Scale Score and Age-Adjusted National Percentile are provided for the Crystallized Cognition Composite. Crystallized Cognition Composite is a more global assessment of individual and group verbal reasoning. Higher scores indicate higher levels of functioning.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Auditory Verbal Learning Test (Rey) measures immediate recall. Unrelated words presented via audio recording and participant recalls as many as possible. he Rey is scored by taking the sum of the number of words recalled across all trials (possible range is 0-45 words). The raw score is most commonly used for interpretation of the Rey test, with higher scores reflecting better episodic memory.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Oral Symbol Digit Test measures speed of processing. Symbols on the screen are associated with a number, then presented with symbols without numbers. The Oral Symbol Digit Test is scored as the number of items answered correctly in 120 seconds (possible range is 0-144).Higher scores indicate better processing speed.

Measured using the Hospital Anxiety and Depression Scale (HADS), which is a 14-item questionnaire divided into two subscales of seven items each measuring anxiety (HADS-A) and depression (HADS-D). Two sub-scores (HADS-A and HADS-D) will be calculated with scores that vary from 0 to 21. Higher scores indicate more anxious/depressive symptoms (Zigmond \& Snaith, 1983).

Self-efficacy will be measured using the Breast Cancer Survivor Self Efficacy Scale. This is an 11-item Likert scale through which participants rate their responses from 1'strongly disagree' to 4, 'strongly agree'. A higher total score indicates better self efficacy.

Self-esteem will be measured pre-intervention and post-intervention (i.e., 8 weeks) using the Rosenberg Self-Esteem scale. This is a 10-item, likert style scale through which participants rate their responses from 1, 'strongly disagree' to 5, 'strongly agree'. Higher total scores indicate better self-esteem.

Objectively assessed PA was measured using Actigraph GTX3+ accelerometers (Pensacola, FL). Participants will wear the accelerometer on their non-dominant hip during waking hours for 7 consecutive days. Data will be downloaded in 60-s epochs and processed and converted to mean counts per minute in ActiLife software package (Version 6; Actigraph) to estimate daily minutes of light (101-1951 counts min-1), moderate (1952-5724 counts min-1), vigorous (≥ 5725 counts min-1), and total moderate-to-vigorous physical activity (MVPA; ≥ 1952 counts min-1) based on established cut-points (Freedson, Melanson, \& Sirard, 1998). Estimated average daily minutes spent in each activity intensity category was calculated by dividing the number of minutes spent in each category by the total number of valid days worn.

The researcher will conduct semi-structured qualitative interviews over videoconferencing that will ask participants about their experience with the study and intervention, including enjoyment, potential barriers faced, and how they felt mentally and cognitively during and after the intervention.

Therapeutic alliance will be measured using the Working Alliance Inventory Short Revised (WAI-SR). This is a Likert scale through which participants rate their responses from 1, 'seldom', to 5, 'always'. A higher total score indicates better therapeutic alliance.

University of Toronto

Assistant Professor

Ellen Warner, MD

This study will primarily identify longitudinal associations between cardiorespiratory fitness (CRF) and cognitive function pre- (baseline) to post-chemotherapy (\~3 months). This will be a prospective study of 50 BCS. We hypothesize that breast cancer patients undergoing chemotherapy who have higher levels of CRF at baseline will have significantly improved measures of attention, executive function, and memory post-chemotherapy. In addition, the exploratory aims will examine the longitudinal associations between physical activity (PA) and cognitive function from pre- to post-chemotherapy and explore the associations between inflammatory and non-inflammatory biomarkers and CRF with cognitive function.

Detailed Description:

Cognitive impairments are reported as a chief quality of life (QoL) complaint by approximately 75% of breast cancer survivors (BCS). Women who have undergone adjuvant chemotherapy are at the highest risk for cognitive impairments, that may affect BCS up to 20 years post-treatment.Despite the prevalence and significance, it is largely underdiagnosed and there are no proven treatments beyond symptom management. Several studies have assessed cognitive function in cancer populations. Increasing evidence highlights the role of lifestyle behaviours on cancer-related outcomes, ranging from QoL to prognosis. However, very few studies have examined the associations of lifestyle factors and cognitive function in BCS.One of the most important mediators of CRCI in BCS may be cardiorespiratory fitness (CRF).

Our overall objective is to examine the behavioral and biological mechanisms that contribute to cognitive decline in BCS undergoing chemotherapy using an epidemiologic, prospective cohort design.

Assessments taken at baseline (pre-chemotherapy) and post-chemotherapy (month 3). Cognitive Function will be assessed using the NIH toolbox cognition battery. Physical Activity. PA will be assessed by accelerometers and through self-report using the Godin-Leisure Time Exercise Questionnaire. Cardiorespiratory Fitness will be assessed using the 6-minute walk test to estimate maximum oxygen uptake (VO2max).Cancer Biomarkers will be assessed using venous blood (2 microtubes) will be drawn from the antecubital vein by a trained phlebotomist. Biological markers analyzed in blood will include a multiplex panel of inflammatory cytokines (i.e., IL1, IL6, TNFα), and brain-derived neurotrophic factor (BDNF).

Our proposed study will be instrumental in designing future targeted translational lifestyle interventions to improve cognitive health in BCS. In addition, understanding the trajectory of cognitive function as it relates to these factors will determine the opportune timeframe to intervene during the cancer care continuum for the greatest impact.

Exercise and Cognitive (Brain) Function in Breast Cancer Patients Getting Chemotherapy After Breast Surgery

Cardiorespiratory Fitness, Inflammatory Biomarkers, and Cognitive Function Patterns During Treatment for Breast Cancer: A Prospective Cohort Study

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). This composite includes all the tests noted above that are fluid ability measures: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the normalized scores of each of the measures, and then deriving scale scores based on this new distribution. An Age-Adjusted Scale Score, Fully Adjusted Scale Score, Unadjusted Scale Score and Age-Adjusted National Percentile are provided for the Fluid Cognition Composite. The Fluid Cognition Composite is a more global assessment of individual and group fluid cognition functioning. Higher scores indicate higher levels of functioning.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Dimensional Change Card Sort Test involves a target visual stimulus that must be matched to 1 of 2 choice stimuli according to shape or color. Scoring is based on an algorithm that weights reaction time. A total of 40 trials require 4 minutes. Higher scores indicate higher levels of cognitive flexibility.

The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The List Sorting Working Memory Test includes a series of stimuli is presented on the computer screen visually (object) and orally (spoken name), 1 at a time. Participants are instructed to repeat the stimuli to the tester in order of size, from smallest to largest. The List Sorting task takes approximately 7 minutes to administer. Test scores consist of total items correct across all trials. Higher scores indicate better working memory.The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Picture Vocabulary Test involves single words that are presented via an audio file, paired simultaneously with 4 screen images of objects, actions, and/or depictions of concepts. The participant will pick the picture that match

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Oral Reading Recognition Test measures the ability to pronounce single printed words and/or to recognize letters. Items are administered by computer adaptive testing (CAT) and participant responses are entered by the tester. The CAT item bank contains approximately 250 items with only 30 to 40 that will be presented, depending on performance. Average administration time is 4 minutes. A higher Computed Score for Reading would mean that the participant is able to correctly identify more difficult words on the subsequent assessment, which may indicate developmental growth or a return to a previous level of functioning.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Pattern Comparison Processing Speed Test requires participants to identify whether two visual patterns are the "same" or "not the same." Average time of administration is 3 minutes and the score is the number of correct items (of a possible 130) completed in 90 seconds. Higher scores indicate faster speed of processing.

Physical activity will be assessed using a modified version of the validated leisure score index (LSI) from the Godin Leisure-Time Exercise Questionnaire (GLTEQ). Participants are asked to recall the average number of times per week and average duration they performed light (minimal effort, no perspiration), moderate (not exhausting, light perspiration), and vigorous (heart beats rapidly, sweating) physical activity during free time in the past month. The percentage of participants meeting the public health aerobic physical activity guidelines was calculated based on the physical activity guidelines recommended for cancer survivors by the American College of Sports Medicine. These guidelines recommend that individuals obtain 75 min of vigorous aerobic physical activity per week, 150 min of moderate aerobic physical activity per week, or an equivalent combination. Thus, will calculated physical activity minutes as moderate minutes plus two times the vigorous minutes.

Cancer Biomarkers will be assessed using venous blood (2 microtubes) will be drawn from the antecubital vein by a trained phlebotomist. Biological markers analyzed in blood will include a multiplex panel of inflammatory cytokines (i.e., IL1, IL6, TNFα), and brain-derived neurotrophic factor (BDNF).

Cardiorespiratory Fitness will be assessed using the six-minute walk test (6MWT) to estimate maximum oxygen uptake (VO2max).The 6MWT measures the distance in meters an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes at their own pace.A lower score (reflecting less distance covered) indicates worse function.

Carcinoma

Receives symptom management assistance from an oncology nurse via the telephone

Receives symptom management assistance from an Automated telephone system

Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management

Nurse

Receives 6 telephone calls over 8 weeks from an programmed automated telephone system to assist with symptom management

Charles Given, PhD

To improve the management of symptoms, patients with cancer undergoing chemotherapy will be monitored using an automated telephone system to record the severity of 15 prevalent symptoms for up to 8 consecutive weeks. Outcomes include; significant reduction in symptom severity and improvement in health states.

Overview: Prevalent symptoms among patients undergoing chemotherapy include: pain, fatigue, dry mouth, constipation, anorexia, nausea, sleep disturbance, shortness of breath or difficulty breathing, as well as psychological symptoms such as depression and anxiety. A survey of 1000 patients with cancer indicated that close to a quarter reported 10-12 symptoms. Given the impact of symptoms upon physical function, work, emotional distress, and hospitalizations, it is critical that strategies be developed and tested to improve symptom management.

This trial of a behavioural intervention for symptom management is significant because: 1) it contrasts a proactive approach, individualized to patients' symptom management needs, with a more conventional model that places responsibility on the patient for symptom management; 2) it controls for the method of delivery and the use of printed material; 3) it targets prevalent symptoms known to affect cancer patients undergoing chemotherapy; 4) it examines the relative effects of each arm, in terms of symptom severity (primary outcome), impact on patients' physical and social roles, and emotional distress; and 5) it explores these outcomes in terms of their impact on the use of services and costs of care.

Goal: The goal of this randomized trial is to determine if a nurse delivered Patient Assisted Management of Symptoms (PAMS) intervention individualized to patients' needs for symptom management, delivered by telephone, when compared to Telephone Information and Monitoring of Symptoms (TIMS) where symptoms are only monitored by telephone, with references to the symptom management toolkit will reduce symptom severity, improve physical function, and other outcomes.

Automated Telephone Monitoring for Symptom Management

Michigan State University

Professor

Symptoms and General Pathology

Fatigue

Pain

Receives symptom management assistance from a non-nurse coach via telephone

Receives 6 telephone calls over 8 weeks from a non-nurse coach to assist with symptom management

Non-nurse coach

Barbara A. Given, PhD, RN, FAAN

Patients with advanced cancer who are undergoing chemotherapy and who report pain and fatigue at intake in the past 24 hours or at a level 2 or higher of pain or fatigue at a 3 or higher on a 10-point scale will be assigned randomly to an 8-week, 6-contact self management attention control (SMAC) intervention, or to a 8-week, 6-contact experimental patient intervention for management of symptoms and support (PIMSS) targeted toward symptom management, reducing impact on physical role and social functioning and emotional distress. Both groups will continue to receive conventional cancer care.

When compared with the self-management attention control intervention, patients exposed to the experimental intervention will report statistically significant positive effects on the following:

1. The primary outcome--total number of symptoms reported;
2. The secondary patient outcomes--reduced deterioration in physical role impact and social functioning, emotional distress, levels of communication with caregiver about care, and communication and satisfaction with provider care; and
3. Caregiver outcomes--greater involvement in symptom management, increased mastery of the caregiving process, reduced levels of depression and burden.

GOAL: The primary goal of this research is to test a symptom management intervention, delivered by nurses with special training, using a stepped-care approach targeted toward pain and fatigue, followed by fifteen other prevalent cancer symptoms. Second goals are to improve physical and social functioning, lower emotional distress, and improve communication with family caregiver in symptom management, and assist them to reduce their levels of depression and burden. This research is funded through a grant from the National Cancer Institutes, and builds upon the Family Care Research Team's program of supportive cancer-care research.

OUTCOMES: This study tests a stepped-approach intervention to determine if it improves symptom outcomes, especially pain and fatigue. Secondary outcomes addressed by the intervention are physical role impact, social functioning, and emotional distress. These outcomes can have significant impact on patients and family caregivers' well-being as patients undergo chemotherapy. The shorter, more intense intervention corresponds to changes int he clinical management of cancer patient with more intense, shorter chemotherapy treatments; therefore, this intervention will be more easily translatable to the clinical setting.

Pain and Fatigue Study

Family Home Care for Cancer - A Community-Based Model

Reduced deterioration in physical role impact and social functioning, emotional distress, levels of communication with caregiver about care and communication, and satisfaction with provider care

Associate Dean of Research, University Distinguished Professor

Breast Cancer patients undergoing chemotherapy will participate in the Walk with Ease program during their treatment.

Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention is a self-directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes a day, five days a week.

Walk With Ease

Hyman B Muss, MD

This study will look at whether or not participating in a physical activity intervention during chemotherapy for breast cancer can prevent a marker of aging called p16 from having a large increase after chemotherapy.

Our research team has determined that p16INK4a - a biomarker of aging -- increases dramatically during chemotherapy and that p16 levels among patients of similar age are lower among those who exercise. We hypothesize that engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. To test this hypothesis, we propose to enroll 48 patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy in a physical activity intervention program. Our primary objective is to compare the change in p16 from baseline to end of chemotherapy for participants in this study (who are engaged in a physical activity intervention) to the mean change in p16 seen in a previous study of similar patients who did not participate in a physical activity intervention. As secondary objectives, we propose to evaluate (1) changes in treatment-related toxicity, physical function, fatigue, and quality of life between baseline, end of chemotherapy and 6 months post-chemotherapy, (2) the association of changes in p16 levels with changes in measures of treatment-related toxicity, physical function, fatigue, and quality of life, and (3) the association of changes in physical activity levels with changes in measures of treatment-related toxicity, physical function, fatigue, and quality of life.

Blood samples will be taken collect p16 levels, CBC + Differential and senescence markers.

The Impact of a Physical Activity Program on Biomarkers of Aging During Chemotherapy for Breast Cancer

Impact of a Physical Activity Program on Biomarkers of Aging During Adjuvant or Neoadjuvant Chemotherapy for Breast Cancer

Mean change in p16 levels measured between baseline to end of chemotherapy, as compared to the historical value seen in a previous study (LCCC810) of similar patients who did not participate in a physical activity intervention

Information obtained through patient-reported surveys and p16 levels obtained from blood samples between baseline to 6 month post-chemotherapy

Information obtained through physician and patient reported surveys.

This objective will use the surveys that measure physical function, fatigue and quality of life to see if they can make any predictions about how these domains may change over the course of chemotherapy.

Changes will be measured over the course of the study

Changes will be measured over the course of chemotherapy

Breast Cancer Research Foundation

UNC Lineberger Comprehensive Cancer Center

Blood and Lymph Conditions

Anemia

Hematologic Diseases

Quality of Life

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Chrysarobin

Iron

Folic Acid

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Epoetin Alfa

Folinic Acid

Methylcobalamin

Folate

Vitamin B9

Vitamin B12

Cobalamin

Cyanocobalamin

Administration of Erythropoietin 150UI/Kg/week divided into 3 doses, IV, for a period of 12 weeks, in patients with hemoglobin between \<12g/dL.

Every week (1 to 12), the study medication will be administered 3 times, according to the proposed treatment, for those allocated in the intervention group. All assessments, procedures and notes must be recorded in a source document and in a CRF.

For the control group, the procedures will be performed according to the institution's standard treatment (Vitamin B12 and folic acid). The use of Iron, Vitamin B12 and folic acid will be allowed both in the intervention arm and in the control arm. Doses should be prescribed at the physician's discretion.

Administration of Erythropoietin 150UI/Kg/week divided into 3 doses, IV, for a period of 12 weeks, in patients with hemoglobin between \<12g/dL

Erythropoietin

Blau Farmacêutica

Research Operations

Clinical Research

Anemia is a frequent complication among cancer patients, both as a result of the malignancy of the disease and the aggressiveness of the treatment. Regardless of the degree of anemia, cancer patients produce less erythropoietin (EPO) and, consequently, cannot compensate for the deficit in the production of red blood cells, a situation that can worsen in presence of inflammation or infection. In the pediatric oncology population, studies vary in relation to anemia treatment protocols, indications for starting treatment and even there is no robust evidence that treatment with erythropoiesis stimulators results in increased hemoglobin levels, even in mild and moderate anemia, with improvement in quality of life scores and fatigue. Therefore, the proposed study aims to test the efficacy and safety of erythropoietin therapy in the treatment of cancer-related anemia in children and adolescents aged 2 to 17 years. As a secondary objective, to evaluate the benefit of early initiation of EPO (Hb\<12g/dL) in children undergoing chemotherapy in improving quality of life and reducing fatigue.

For the evaluation of secondary outcomes, the Student's t test can be applied and analyzes of variance or covariance (ANOVA or ANCOVA) (with treatment group as a factor, and baseline hemoglobin level as a covariate) will be used to compare the outcomes of efficacy defined by variation (change) time point post versus baseline between 2 groups. Adjusted means ("least square means") with 95% CI will be reported. When applicable, secondary outcomes defined by continuous variables evaluated over time (3 or more instants) will be analyzed using mixed model analysis of variance for repeated measures

This study will be carried out in approximately 10 participating Brazilian centers.

This is a multicenter, open-label, randomized, national study. Randomization will be performed in a 1:1 ratio, in which 160 participants will be allocated to the intervention arm (Erythropoietin 150UI/Kg/week, divided into 3 doses, IV) and 160 participants to the local institution's standard care arm: Iron, Vitamin B12 and Folic Acid. Doses should be prescribed at the physician's discretion.

Every week (1 to 12), the study medication will be administered 3 times, according to the proposed treatment, for those allocated in the intervention group. All evaluations, procedures and notes must be recorded in a source document and in a CRF (case report form) The use of Iron, Vitamin B12 and folic acid will be allowed both in the intervention arm and in the control arm. Doses should be prescribed at the physician's discretion.

Asses the Impact of Early Starting Erythropoetin in the Reduction of Transfusions Blood in Childrens

Phase III Study, Multi-center, Open, Randomized, to Assess the Impact of Early Starting Erythropoetin in the Reduction of Transfusions Blood and Improvement of Quality of Life and Fatigue in Children Under Chemotherapy Treatment.

Increase of at least 1g/dL in hemoglobin levels within 12 weeks. The main outcome will be described in absolute and relative numbers. 95% Confidence Intervals

Requirement of blood cell transfusion will be assessed as number of units received on a weekly basis

We will apply the POQOLS (Pediatric Oncology Quality of Life Scale) and the PedsQL TM Multidimensional Fatigue Scale, both validated for pediatric population and in Portuguese language. The POQOLS includes 21 items distributed in three dimensions, which include "physical function and normal activities restriction" (09 items), "emotional problems" (07 items), and "response to active medical treatment" (05 items). Each answer is given on an ordinal scale of 7 points ranging from "never" to "very often". The resulting total score is given on a scale, and higher values mean lower quality of life.

We will apply the POQOLS (Pediatric Oncology Quality of Life Scale) and the PedsQL TM Multidimensional Fatigue Scale, both validated for pediatric population and in Portuguese language. The PedsQL TM Multidimensional Fatigue Scale items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher PedsQL Multidimensional Fatigue Scale scores indicate fewer symptoms of fatigue.

Adverse events will be monitored from the time the participant gives informed consent and up to 30 days after the last dose of study medication. Adverse events will be classified according to their severity and causality, being reported to the sponsor according to regulatory deadlines.

Blau Farmaceutica S.A.

Neoplasm Metastasis

Neoplastic Processes

The intervention is characterized by the randomization into thoracic arm which means that patients will have an implantable Venous Access Device implanted into thoracic location

The intervention is characterized by the randomization into humeral arm which means that patients will have an implantable Venous Access Device implanted into humeral location

Implantation of intravenous medical device in thoracic location

IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.

Implantation of intravenous medical device in humeral location

Vital Port®Minititanium

Laurence CROUZET, MD

The aim of this study is to compare the humeral and thoracic implantation of a central venous access by an implantable device in patients with solids tumors who require intravenous chemotherapy. This is a monocentric randomized study. 572 patients will be recruited for 2 years. They will be randomized either in the thoracic implantation, either in the humeral implantation Due to the 1:3 randomization, 143 patients will be randomized in the humeral arm and 429 into the thoracic one. Number of complications related to the implantable device, medico-economic analysis as well as patient satisfaction will be assessed.

Every patients with solid tumor requiring medical device implantation for intravenous chemotherapy treatment will be eligible.

Both humeral and thoracic implantation of medical device are standard procedures. The randomization in a specific arm is the study procedure and is considered as an interventional study in France.

Comparison of Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Chemotherapy

Phase IV Study Comparing Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Intravenous Chemotherapy

Number of complications that will be recorded by medical oncologist

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Combined Exercise Training Program for Women Living With Breast Cancer	NCT05704855	Breast Cancer	Combined Exerci... Active Control	40 Years - 65 Years	University of Toronto
Exercise and Cognitive (Brain) Function in Breast Cancer Patients Getting Chemotherapy After Breast Surgery	NCT04616300	Breast Cancer		18 Years - 65 Years	University of Toronto
Automated Telephone Monitoring for Symptom Management	NCT00799084	Carcinoma	Nurse AVR	21 Years -	Michigan State University
Pain and Fatigue Study	NCT00006253	Carcinoma	Nurse Non-nurse coach	21 Years -	Michigan State University
The Impact of a Physical Activity Program on Biomarkers of Aging During Chemotherapy for Breast Cancer	NCT02167932	Breast Cancer Aging	Walk With Ease	21 Years - 59 Years	UNC Lineberger Comprehensive Cancer Center
Asses the Impact of Early Starting Erythropoetin in the Reduction of Transfusions Blood in Childrens	NCT05704894	Anemia Neoplasms Chemotherapeuti...	Erythropoietin	2 Years - 17 Years	Blau Farmaceutica S.A.
A Combined Exercise Training Program for Women Living With Breast Cancer	NCT05704855	Breast Cancer	Combined Exerci... Active Control	40 Years - 65 Years	University of Toronto
Comparison of Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Chemotherapy	NCT03410121	Solid Tumor, Ad... Chemotherapy Tr... Advanced or Met...	IPolysite ® Min... Vital Port®Mini...	18 Years -	Center Eugene Marquis

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