Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Xerostomia

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Participants recruited between weeks 3-5 of radiotherapy. Acupuncture treatments given within 3 to 7 days of each other during Weeks 3-5 of regularly scheduled radiotherapy visits. It should take about 20 minutes to complete the acupuncture session each time.

At each acupuncture session, 3 questionnaires completed before each session that ask about dry mouth, any other symptoms, and treatment expectations. It should take about 5 minutes total to complete these questionnaires. Participants also complete another brief questionnaire about dry mouth after each session. It should take about 1 minute to complete this questionnaire.

Participants also have an EEG at each acupuncture treatment. EEG recorded 5 minutes before acupuncture, during acupuncture, and for 5 minutes after acupuncture. Total visit time will last about 45-60 minutes.

At each acupuncture session, 3 questionnaires completed before each session that ask about dry mouth, any other symptoms, and treatment expectations. It should take about 5 minutes total to complete these questionnaires. Participants also complete another brief questionnaire about dry mouth after each session. It should take about 1 minute to complete this questionnaire.

Questionnaires

Acupuncture treatments given within 3 to 7 days of each other during Weeks 3-5 of regularly scheduled radiotherapy visits. It should take about 20 minutes to complete the acupuncture session each time.

Acupuncture

Participants have an EEG at each acupuncture treatment. EEG recorded 5 minutes before acupuncture, during acupuncture, and for 5 minutes after acupuncture. Total visit time will last about 45-60 minutes.

Electroencephalogram (EEG)

Lorenzo Cohen, PHD

The goal of this clinical research study is to learn which areas of the brain respond to acupuncture that is designed to prevent xerostomia (dry mouth) in patients with head and neck cancer. Researchers also want to learn if acupuncture can help prevent dry mouth and improve patient quality of life.

Dry mouth is a common problem in cancer patients who have received radiation treatment to the head and neck. Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, stainless steel needles into the skin at specific points.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) into 1 of 2 groups. You will have an equal chance of being in either group.

Group 1 will receive one type of acupuncture for one session and another type of acupuncture for the second session.

Group 2 will receive one type of acupuncture for one session and another type of acupuncture for the second session.

You will not know if you are assigned to Group 1 or Group 2.

Study Visits:

Your acupuncture treatments will be within 3 to 7 days of each other during Weeks 3-5 of your regularly scheduled radiotherapy visits. It should take about 20 minutes to complete the acupuncture session each time.

At each acupuncture session, you will complete 3 questionnaires before each session that ask about dry mouth, any other symptoms you may be having, and your treatment expectations. It should take about 5 minutes total to complete these questionnaires. You will also complete another brief questionnaire about dry mouth after each session. It should take about 1 minute to complete this questionnaire.

You will also have an EEG at each acupuncture treatment. The EEG will be recorded 5 minutes before acupuncture, during acupuncture, and for 5 minutes after acupuncture. Total visit time will last about 45-60 minutes.

You will give a saliva sample before and after each acupuncture treatment to measure the amount of saliva produced.

Length of Study:

You will remain on study for about 1 week. Your participation in the study will be over after you complete the dry mouth questionnaire after your second acupuncture session.

This is an investigational study.

Up to 50 patients will take part in this multicenter study. Up to 30 will be enrolled at MD Anderson.

Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia

Primary outcome variables include percentage changes of EEG scores at the medial frontal gyrus, precuneus, and anterior cingulate regions from pre- to post-acupuncture at each acupuncture session. Repeated measures ANOVA used for the analysis, with fixed effects of sequence (order of acupuncture sessions), treatment (each acupuncture group), and period (1st vs 2nd session), and random patient (nested within sequence) effects included. Adjustments for multiple testing made according to the method of Westfall and Young.

Secondary outcomes are to determine between-acupuncture differences in radiation-induced xerostomia. Association examined between changes in neural outcomes and changes in salivary flow and self-report measures of xerostomia and other quality of life measures, controlling for the factors of acupuncture and period (1st vs 2nd) as appropriate.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Blood and Lymph Conditions

Behaviors and Mental Disorders

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Substance Related Disorders

Leukemia

Cognitive Dysfunction

Sarcoma

Lymphoma

Hodgkin Disease

Testicular Neoplasms

Chemotherapy-Related Cognitive Impairment

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Soft Tissue Sarcoma

Lymphosarcoma

Hodgkin Lymphoma

Patients diagnosed with solid tumor cancers

Patients diagnosed with haematological cancers

Lisa L Hjalgrim, PhD, MD

Barbara Nordhjem, PhD

Barbara JT Nordhjem, PhD

Helle Pappot, Professor, MD

The MyBrain study investigates the brain function of children, adolescents and young adults during and after chemo treatment for cancer. The tests include 1) cognitive skills such as memory and attention; 2) the brain's electrical activity; 3) and biological markers related to brain function.

The aim of the study is to better understand the trajectories of cognitive functioning and measures that have been associated with cognitive impairment in patients treated with chemotherapy.

Background:

Numerous studies indicate that many patients with cancer, regardless of cancer type, develop cancer-related cognitive impairment (CRCI), which may persist for many years after ended treatment. CRCI can occur regardless of cancer type and most often affects cognitive domains, such as memory, attention processing speed, and executive functions. In daily life, this may manifest as difficulties in attention and concentration, learning, multitasking, mentally organize tasks, and cognitive fatigue. The cognitive impact of cancer and cancer treatments for non-CNS patients has been shown with several research disciplines, such as neuropsychological tests, neuroimaging, biomarkers, and animal studies.

Cognitive impairment affects children, adolescents, and young adults with cancer and their families. Young cancer patients may be particularly vulnerable to cognitive impairment as the brain undergoes development in childhood and continues into the twenties. However, there is a lack of knowledge about when a decrease in cognitive capacity may occur, how long it will persist, and which cognitive domains are affected for children adolescents and young adults with cancer.

Aim:

MyBrain is an explorative study which will explore and describe trajectories of CRCI as measured by neuropsychological assessment, self-reported quality of life and fatigue, brain functioning measured with electroencephalogram (EEG), and biomarkers of neural impairment and inflammation.

Design:

Single-centre, prospective longitudinal study including patients diagnosed with cancers outside the brain at age 7-29 years. Each patient is paired with a healthy control matched on age and social circle.

Time points:

The MyBrain study includes patients with different cancer types and assigned to different treatment protocols. Therefore, some patients will undergo treatment for several months (for instance testicular cancer, lymphomas), while others will be treated over several years (acute lymphoblastic leukaemia). The measurement time points will vary between different protocols.

T0: Patients are assessed as close to the day of diagnosis as possible, within 30 days from the day they receive their diagnosis.

T1abc: Up to three time points (2-3) during chemo treatment. Blood samples will be taken immediately before and 10-14 days after the chemo dosing for the specific chemo cycles. For patients who receive more than three cycles of chemotherapy, the timepoints T1abc, will be placed at the chemo treatments with the highest doses (denoted the major chemo treatments) according to the treatment protocol the patient follows. If the treatment protocol allocates the same dose to all chemo treatments, the T1abc will be placed with the aim to obtain approximate equidistance between T0, T1abc and T2.

HDM1-3: Three additional time points during treatment for the patients who are treated with high dose methotrexate (HDM). Blood samples will be taken immediately before and 10-14 days after HDM treatment.

T2: End of treatment. End of treatment is defined as two weeks after the final antineoplastic treatment. For ALL patients, end of treatment is defined as the end of consolidation treatment.

T3: Follow-up, 6 months after T2.

All outcome measures are collected at the time points T0, T2 and T3 for patients and at similar time intervals for controls. T1abc and HDM1-3 only includes biological samples from the patients.

Data includes:

* Clinical information obtained from medical charts including cancer diagnosis, treatment protocol, duration of treatment and adverse events.
* Sociodemographic information collected with a brief questionnaire which includes level of education, occupation, economic status, and the parents' level of education and occupation.
* Cognitive functioning assessed with a clinical battery. The battery includes: Nepsy-II Verbal Fluency, Wechsler Coding (WISC-V or WAIS-IV), Wechsler Symbol Search (WISC-V or WAIS-IV), RBANS Word List Memory, RBANS Word List memory recall, RBANS Word List memory recognition, Wechsler Vocabulary (WISC-V or WAIS-IV), Wechsler Matrix (WISC-V or WAIS-IV), Digit Span (WISC-V or WAIS-IV), Conner´s CPT-III, Grooved Pegboard. For the Wechler tests, participants \<16 years of age are tested with WISC-V and participants 16 or older are tested with WAIS-IV.
* Cognitive functioning assessed with the Cambridge Neuropsychological Test Automated Battery (CANTAB). The following tests are included: Spatial Working Memory, Pattern Recognition Memory, Spatial Span, Paired Associates Learning, Pattern Recognition Memory (delayed), Delayed Matching to Sample.
* Qualitive of life measured with the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales 4.0
* Fatigue measured with the PedsQL Multidimensional Fatigue Scales 3.0
* Resting state EEG is recorded with eyes-open (EO) and eyes-closed (EC) in four blocks of three minutes each (EO-EC-EO-EC).
* Event-related potentials (ERP) during a two-tone auditory oddball task. The participants are instructed to mentally count the rare stimulus.
* Biomarkers of associated with cognitive functioning, measured in serum: neurofilament light chain, glial fibrillary acidic protein, brain derived neurotrophic factor, and pro- and anti-inflammatory markers (IFNy, IL10, IL12p70, IL17A, IL6, TNFa and IL1β).
* Biomarkers of associated with cognitive functioning, measured in cerebrospinal fluid (CSF) for the haematological patients if CSF is drawn as part of their treatment: neurofilament light chain, glial fibrillary acidic protein, brain derived neurotrophic factor, pro- and anti-inflammatory markers.

Data analyses Large inhomogeneity in the data is expected due to the inclusion of patients over a wide age-span with different cancer types, varying treatment protocols, and varying timelines from diagnosis to end of treatment and there are no predefined, specific hypotheses due to the many sources of inhomogeneity. All analyses are exploratory, and confidence limits (rather than nominal p-values) will be used as the indication of the strength of an association when quantified in statistical analyses.

The initial analyses will be data visualizations of quantitative variables will include trajectories for single variables, bivariate plots with smoothed mean curves added, and plots of patient observations against the corresponding observations for the matched control connecting the points in temporal order for each matched pair. The trajectories will be presented for different timescales, e.g., time since diagnosis, or time from T2. Potential risk factors, like cancer type, sex, or age will be indicated in the data visualizations by using different colours and symbols.

Neurocognitive test scores will be investigated at each time point (T0, T2, and T3) for each subtest. Raw as well as scaled scores, age-adjusted from Danish population norms, will be used in the analysis. For the visualizations of the raw test scores, the scores will be plotted as a function of age including reference curves based on back-converted means, ±SD, and -2 SD.

Investigating Cognitive Impairment in Young Patients With Cancer Prospectively

A Multidisciplinary Neuroscience Approach to Investigate Cognitive Impairment in Young Patients With Cancer Prospectively

Scores on the clinical neurocognitive tests (Wechler Intelligence Scale for Children Fifth edition for participants 7-15.9 years of age, Wechler Adult Intelligence Scale Fourth edition for participants 16 years of age or older). Scaled scores range from 0-19, higher = better performance.

The Grooved Pegboard (Lafayette Instrument) is a neurocognitive test consisting of consisting of key shapes (pegs) and matching holes used to test visual-motor coordination. Scores are in milliseconds, lower scores = better performance.

The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtests List Learning, List Recall and List Recognition evaluates learning and memory. Scaled scores (t-scores) range from 0-100, higher = better performance.

The Conner's Continuous Performance Test Third edition evaluates attention-related performance in areas of inattentiveness, impulsivity, sustained attention, and vigilance. Scaled scores (t-scores) range from 0-100, higher = better performance.

The NEPSY Second edition Verbal Fluency subtest is used to evaluate executive and verbal cognitive skills. The scores are the number of correct words generated for the two semantic and two lexical fluency tasks, rang 0-no upper limit, more words = higher score.

Neuropsychological functions measured with the Cambridge Neuropsychological Test Automated Batteries(CANTAB), using the subtests Spatial Working Memory, Pattern Recognition Memory, Spatial Span, Paired Associates Learning, Pattern Recognition Memory (delayed), Delayed Matching to Sample. The tests can generate several outcomes, % of correct responses will primarily be used (0-100, higher = better performance).

Pediatric Quality of Life Inventory Generic Core Scales 4.0 (5-point Likert scale from 0 (Never) to 4 (Almost always), lower meaning better outcome).

Pediatric Quality of Life Inventory Multidimensional Fatigue Scales 3.0 (5-point Likert scale from 0 (Never) to 4 (Almost always), lower meaning better outcome).

Absolute power (microvolts squared) in the delta band.

Absolute power (microvolts squared) in the theta band.

Absolute power (microvolts squared) in the alpha band.

Absolute power (microvolts squared) in the beta band.

Amplitude (in microvolts) of the P300 peak.

Latency (in microseconds) of the P300 peak.

Concentration (pg/ml) of neurofilament light chain, glial fibrillary acidic protein, brain derived neurotrophic factor, pro- and anti-inflammatory markers (IFNy, IL10, IL12p70, IL17A, IL6, TNFa and IL1β).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia	NCT02292368	Head and Neck C...	Questionnaires Acupuncture Electroencephal...	18 Years -	M.D. Anderson Cancer Center
Investigating Cognitive Impairment in Young Patients With Cancer Prospectively	NCT05840575	Chemotherapy-Re... Chemotherapeuti... Chemo-brain Cancer Childhood Cance... Hodgkin Lymphom... Non Hodgkin Lym... Testicular Canc... Sarcoma Leukemia		7 Years - 29 Years	Rigshospitalet, Denmark
Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia	NCT02292368	Head and Neck C...	Questionnaires Acupuncture Electroencephal...	18 Years -	M.D. Anderson Cancer Center
Investigating Cognitive Impairment in Young Patients With Cancer Prospectively	NCT05840575	Chemotherapy-Re... Chemotherapeuti... Chemo-brain Cancer Childhood Cance... Hodgkin Lymphom... Non Hodgkin Lym... Testicular Canc... Sarcoma Leukemia		7 Years - 29 Years	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for electroencephalogram