Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Substance Related Disorders

Breast Neoplasms

Cognitive Dysfunction

Chemotherapy-Related Cognitive Impairment

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

All Drugs and Chemicals

Central Nervous System Stimulants

Nicotine

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Nicotine will be delivered by a transdermal patch delivery system for topical application. Each patch will contain approximately 1.75mg nicotine/cm2, and releases 7, and 14mg of nicotine, respectively, over 24 hours. Patches will be applied for 16 hours per day. Participants will be titrated over the course of the 6-week treatment period in order to avoid initial side effects as follows:

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence.

Transdermal nicotine

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Placebo Transdermal Patch

Paul A Newhouse, M.D.

The purpose of this study is to evaluate the use of a nicotine patch as a treatment for problems with attention, learning and memory in breast cancer patients who are 1-5 years post chemotherapy.

Studies have suggested that chemotherapy treatment for breast cancer may change the way the brain functions. As a result, patients who receive chemotherapy for breast cancer may experience problems with their attention, learning, and memory that they did not have before receiving chemotherapy. The investigators have found that nicotine treatment can help other types of patients with similar difficulties with attention, learning, and memory. Nicotine is a naturally occurring substance found in tobacco and is known to interact with nerve cells in the brain that are important for functions like learning and memory, and has been studied in a number of disorders. This study is designed to test whether nicotine treatment is helpful for learning and memory problems after chemotherapy for breast cancer.

This study will be a randomized, placebo-controlled pilot study to evaluate the effect of transdermal nicotine to 1) reduce subjective complaints and 2) enhance cognitive performance on laboratory measures of cognitive performance in breast cancer patients with persistent chemotherapy-related cognitive impairment (CRCI), a condition also known as "chemo brain." Participants will be randomized to either placebo or active compound (50/50) for the 6-week treatment portion of the study. Participants will be assessed before, during, and at the end of treatment. At the end of the 8-week study, participants will have the option to take part in the open-label portion of the study for an additional 6 weeks.

Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study

The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale will be used to monitor change in CRCI subjective complaints.

This instrument has been used to monitor change in CRCI subjective complaints in previous studies and demonstrates good internal consistency, test-retest reliability, and discriminant and convergent validity. Specifically, the PCI subscale was used as the primary outcome measure.

The FACT-Cog PCI consists of 20 items and has a minimum score of 0 and total possible score of 72. Higher scores indicate better cognitive functioning.

The PCI evaluates memory, concentration, mental acuity, verbal fluency, functional interference, and multitasking ability.

Visit 3 is the 3-week visit, Visit 4 is the 6-week visit, and Visit 5 is the 8-week visit.

Change scores were calculated as follow

The secondary outcome measure was the computerized Conners Continuous Performance Test (CPT), which measures sustained attention and vigilance. Participants see a series of letters appearing one at a time on a computer screen and they press a button for every letter that appears on the screen, except for "X". Lower scores indicate better performance.

Scores on the CPT are calculated using the each participant's performance on the task (defined as reaction time (in ms) standard error/interstimulus interval). Change scores from baseline are then calculated. A decrease in CPT score = improvement.

\*This is not a clinical measure. This is a research measure of reaction time variability and therefore there is no clinical interpretation and no defined score range.\*

Vanderbilt University Medical Center

Professor of Psychiatry, Pharmacology, and Medicine

Adverse events were recorded and categorized by body system, event type, attribution, frequency, severity, and course. AEs were assessed across all double-blind study visits and categorized according to body system for all participants who received at least one dose of patches (nicotine n = 12, placebo n = 13).

Nicotine will be delivered by a transdermal patch delivery system for topical application. Each patch will contain approximately 1.75mg nicotine/cm2, and releases 7, and 14mg of nicotine, respectively, over 24 hours. Patches will be applied for 16 hours per day. Participants will be titrated over the course of the 6-week treatment period in order to avoid initial side effects as follows:

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Transdermal nicotine: Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence.

Transdermal Nicotine

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Placebo Transdermal Patch

Placebo

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Cancer Type

Cancer Stage

Chemotherapy

Surgery

Radiation

Cancer Treatment Received

Current Endocrine Therapy

Post-Menopausal Status

Small sample size numbers; treatment duration of 6-weeks may not have been enough time to distinguish between a drug and placebo response; 14mg may not have been a sufficient dose to fully test this hypothesis.

Dr. Paul A. Newhouse

For the Primary Aim (Specific Aim 1), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline PCI FACT-Cog score (Visit 3, Visit 4, and Visit 5) as the dependent measure.

Visit 3 PCI Change from Baseline Score (3-Weeks)

Visit 4 PCI Change from Baseline Score (6-Weeks)

Visit 5 PCI Change from Baseline Score (8-Weeks)

Change in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) PCI Scale

For the Secondary Aim (Specific Aim 2), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline CPT Scores (Visit 3, Visit 4, and Visit 5) as the dependent measure.

Visit 3 CPT Change from Baseline Score (3-Weeks)

Visit 4 CPT Change from Baseline Score (6-Weeks)

Visit 5 CPT Change from Baseline Score (8-Weeks)

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Placebo Transdermal Patch: Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Conners Continuous Performance Test

Overall Study

Breast Diseases

Skin Diseases

Defined exercise program up to four times per week including high-intensity-interval-training for one year of active study intervention.

High-Intensity-Interval-Training

Patients will be given general physical activity recommendations during chemotherapy.

General Physical Activity Recommendations

Milan R Vosko, MD, PhD

David Kiesl, MD

The "ECCO"-study evaluates the efficacy of simultaneous controlled exercise during neo/-adjuvant chemotherapy in breast cancer patients and its effects on neurocognition.

In this study the investigators examine the benefits of the individualized high intensity training program on a cancer related cognitive impairment.

Changes in patients' cognition are evaluated by neuropsychological testing. Possible structural changes are detected with MRI volumetry. Biomarkers connected to Cancer Related Cognitive Impairment (CRCI) and chemotherapy related inflammatory processes which impair cognition, respectively, will be assessed.

Background: Epidemiological research indicates that increased levels of physical activity are associated with decreased breast cancer risk and mortality. Thereby, exercise programs can substantially increase patients' quality of life during and after treatment. Up to 80% of breast cancer patients demonstrate a decrease in their cognitive capacity, summarized as the symptom-complex "Cancer Related Cognitive Impairment (CRCI)". Most frequently reported impairments are mild to moderate deficits in processing speed, attention, memory and executive functions. In about 35% of affected patients, cognitive symptoms persist for months, or even years, after completion of medical treatment, impairing daily functioning, limiting ability to return to work and decreasing overall quality of life. Recent studies indicate a key role of inflammatory pathways in the CRCI genesis. Attention to physical activity therefore as a potential supportive care option is increasing. Anyhow, evidence for positive effects of exercise on CRCI is still lacking.

Patients and Methods: This prospective, two-arm, 1:1 randomized, controlled trial aims to investigate the influence of high-intensity training interventions accompanying neo/-adjuvant chemotherapy on CRCI in 126 patients with early breast cancer on cognitive performance measured by the California Verbal Learning Test (CVLT). Secondary endpoints include subjective markers and tests for cognitive performance and inflammatory biomarkers as TNF-α, IL-6, IL-1α, IL-1ß which are suspected to be involved in the pathogenesis of CRCI. As cognitive impairments are believed to be connected to either functional and/or morphological hippocampal damage due to chemotherapy, head MRIs and hippocampal volume measurements will be performed. In addition to a heart rate controlled home-based endurance and strength training for one year, participants in the intervention group will perform a supervised high-intensity interval training (HIIT) exercise program at least once a week. This study will help to clarify whether a long-term supervised exercise intervention program affects CRCI in breast cancer patients and help to reason underlying mechanisms and the pathogenesis of the chemobrain.

Exercise, Cancer and Cognition: The ECCO-Study

Randomized Controlled Trial of Simultaneous Exercise During Neo-/Adjuvant Chemotherapy in Breast Cancer Patients and Its Effects on Neurocognition

The primary endpoint is measured by the changes in the total score of the California Verbal Learning Test (CVLT), measured 12 months after baseline assessment. Total points of the score are 176 pts., with less points indicating a worse outcome/ cognitive impairment and more points a better outcome/ cognitive function.

Devation of hippocampal volume measured 12 months after baseline assessment.

German Sport University, Cologne

University of Graz

Charite University, Berlin, Germany

Charles University, Czech Republic

Johannes Kepler University of Linz

Principal Investigator

This group will be treated with the MAAT-YS cognitive-behavioral therapy.

MAAT is an evidence-based cognitive-behavioral therapy composed of eight 45-minute telehealth appointments and an accompanying workbook.

MAAT-YS

Chloe A Sinagra

Robert J Ferguson, PHD

Brenna Brenna, PsyD

Jessica N. Bailey, BS

Brenna C. McDonald, PsyD

University OPSOMHC Center, PHD

Robert J. Ferguson, PhD

Tara Brinkman, PHD

Stephanie Guthrie, RN, BSN, CCRP

The goal of this clinical trial is to pilot-test a modified version of telehealth-delivered Memory and Attention Adaption Training (MAAT) that is tailored to young adult childhood cancer survivors (ages 18-39; MAAT-YS) with cancer-related cognitive impairment (CRCI). MAAT-YS consists of 8 weekly visits (45-minutes in duration) and participants use a survivor workbook and complete homework between visits. Participants in this single-group pilot trial (N=9) will complete online self-report measures of cognitive symptoms, quality of life, treatment satisfaction and a brief online neuropsychological test battery at baseline and post-MAAT-YS timepoints.

The goal of this clinical trial is to pilot-test a modified version of telehealth-delivered Memory and Attention Adaption Training (MAAT) that is tailored to young adult childhood cancer survivors (ages 18-39; MAAT-YS) with cancer-related cognitive impairment (CRCI). MAAT-YS consists of 8 weekly visits (45-minutes in duration) and participants use a survivor workbook and complete homework between visits.

This pilot trial will determine MAAT-YS feasibility, treatment satisfaction and size of effect in self-report and objective measures of neurocognitive function.

Eligible participants will be 9 individuals who were diagnosed with non-central-nervous system (CNS) cancer (including leukemia/lymphoma without known CNS involvement) prior to the age of 18, are at least 1-year from completion of cancer treatment, including chemotherapy.

Participants will complete online self-report measures of cognitive symptoms, quality of life, treatment satisfaction and a brief online neuropsychological test battery at baseline and post-MAAT-YS timepoints.

If successful, further research is planned with a larger, multi-site randomized controlled trial of MAAT-YS.

MAAT For Young Adult Cancer Survivors

Modifying Memory and Attention Adaptation Training (MAAT) For Young Adult Childhood Cancer Survivors

There is no data sharing plan with other institutions for this pilot trial.

The MAAT-YS Fidelity Checklists assess the degree to which the MAAT-YS study clinician adheres to specific therapeutic behaviors of the MAAT-YS Clinician Manual. The checklists are administered to 2 independent treatment adherence raters who review randomly selected audio recordings of each of the 8 telehealth-delivered MAAT-YS visits. Behaviors in checklists per each visit are independently rated 0 (no or poor fidelity) to 10 (highest fidelity possible). Rating means are computed for each visit for a score of 0-10 with higher scores denoting higher treatment fidelity.

The PCI assesses perceived cognitive function of participants within a timeframe of the previous 7 days. It consists of 18 items with a 5-point Likert-type rating of 0 (Never) to 4 (Several times a day) with a scoring range of 0-72. Scoring instructions indicate items are reverse scored, such that higher scores denote better perceived cognitive function, lower scores, poorer cognitive function.

CNSVS Verbal Memory (VBM) is a computer-based neuropsychological test of word recognition and memory for words). The test is measured in standard score units (Mean of 100; SD 15). Higher scores denote better cognitive function.

CNSVS Symbol Digit Coding (SDC) is a computer-based neuropsychological test of visual motor processing speed. The test is measured in standard score units (Mean of 100; SD 15). Higher scores denote better cognitive function.

CNSVS Stroop Test (ST) is a computer-based neuropsychological test of visual motor reaction time, processing speed and visual discrimination. The test is measured in standard score units (Mean of 100; SD 15). Higher scores denote better cognitive function.

CNSVS 4-Part Continuous Performance Test (FPCPT) is a computer-based neuropsychological test of sustained attention and working memory. The test is measured in standard score units (Mean of 100; SD 15). Higher scores denote better cognitive function.

The IQOL assesses perceived quality of life impact of cognitive symptoms participants experience within a timeframe of the previous 7 days. It consists of 4 items with a 5-point Likert-type rating of 0 (Not at all) to 4 (Very Much) with a scoring range of 0-16. Scoring instructions indicate items are reverse scored, such that higher scores denote better quality of life, lower scores, poorer quality of life.

The CSC-W-21 is a 21-tem self-report measure of perceived impact of cognitive symptoms on work (occupational)-related tasks. Respondents are asked to indicate "yes" (1 point) or "no" (0 points) to each item. Higher scores, ranging from 0-21, denote more work-related cognitive symptoms.

The MIA-A is a 14-item scale that uses a 5-point Likert-type rating for each item (1= Disagree Strongly; 5 Agree Strongly) with item 13 reverse scored. Items are summed with higher scores (range from 14-70) denoting more anxiety associated with perceived cognitive problems in daily life.

The PROMIS Anxiety v.1 Short Form 4a scale evaluates self-reported fearfulness, cognitive focus, and concentration, as well as emotional distress related to worry and feeling uneasy over the past 7 days. It consists of 4 items, each rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a scoring range of 4 to 20. Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10).Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10). Higher scores denote more anxiety.

The PROMIS Depression v.1 Short Form 4a scale evaluates self-reported negative mood, helpless and worthlessness over the past 7 days. It consists of 4 items, each rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a scoring range of 4 to 20. Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10). Higher scores denote more depression.

The PROMIS Fatigue v.1 Short Form 4a scale evaluates self-reported symptoms of exhaustion, fatigue and interference with daily activity over the past 7 days. It consists of 4 items, each rated on a 5-point scale (1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; and 5=very much) with a scoring range of 4 to 20. Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10). Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10). Higher scores denote more anxiety.

The PROMIS Global Health Physical scale is a self-report measure assessing physical health and ability. It consists of 2 items with a 5-point Likert-type rating of 1 (Poor) to 5 (Excellent) with a scoring range of 2-10. Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10). Higher scores denote better physical health.

The PROMIS Global Health Mental scale is a self-report measure assessing mental health and ability. It consists of 2 items with a 5-point Likert-type rating of 1 (Poor) to 5 (Excellent) with a scoring range of 2-10. Raw scores are converted to T-scores using PROMIS norms (mean = 50; SD = 10). Higher scores denote better mental health.

The CEQ is a self-report measure assessing the credibility and expectancy of treatment received. It consists of 6 items, 4 items with a 9-point Likert-type rating of 1 (not at all) to 5 (very much) with a scoring range of 3-27. The other 2 items are on a percentage scale from 0%-100% in increments of 10 with a scoring range of means 0-100%. Higher scores denote higher treatment credibility and expectancy.

The Treatment Satisfaction (TSS) questionnaire is a self-report measure assessing satisfaction of treatment. It consists of 5 items with a 5-point Likert-type rating of 0 (not at all) to 8 (completely) with a scoring range of 0-40 and 1 additional yes/no item about whether traveling for treatment is possible for participation. Higher scores denote more satisfaction with treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study	NCT02312934	Chemo Brain Chemotherapy-re... Chemo Fog Breast Cancer Chemobrain	Transdermal nic... Placebo Transde...	35 Years - 80 Years	Vanderbilt University Medical Center
Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study	NCT02312934	Chemo Brain Chemotherapy-re... Chemo Fog Breast Cancer Chemobrain	Transdermal nic... Placebo Transde...	35 Years - 80 Years	Vanderbilt University Medical Center
Exercise, Cancer and Cognition: The ECCO-Study	NCT04789187	Breast Cancer	High-Intensity-... General Physica...	18 Years - 70 Years	Johannes Kepler University of Linz
MAAT For Young Adult Cancer Survivors	NCT06150976	Cancer	MAAT-YS	18 Years - 39 Years	University of Pittsburgh
Exercise, Cancer and Cognition: The ECCO-Study	NCT04789187	Breast Cancer	High-Intensity-... General Physica...	18 Years - 70 Years	Johannes Kepler University of Linz

Spots Global Cancer Trial Database for crci

Every month we try and update this database with for crci cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for crci

Every month we try and update this database with for crci cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for crci cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.