Symptoms and General Pathology

All Conditions

Neoplasms

Behaviors and Mental Disorders

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Cognition Disorders

Brain Neoplasms

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Brain Tumor, Adult

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Lomustine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Lomustine 90 mg/m² every 6 weeks (cap. 160 mg) + bevacizumab 10 mg/kg every 2 weeks (at further progression treatment will be according to investigators discretion). In the absence of hematological toxicity \> grade 1 during the first cycle the dose of lomustine can be escalated to 110 mg/m² (cap 200 mg) in their second cycle.

Lomustine single agent 110 mg/m² every 6 weeks (cap. 200 mg) (at further progression treatment will be according to investigators discretion).

bevacizumab

lomustine

DNA methylation analysis

laboratory biomarker analysis

cognitive assessment

quality-of-life assessment

Wolfgang Wick, Pr.

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which regimen of bevacizumab given together with lomustine is most effective in treating patients with glioblastoma multiforme in first recurrence.

PURPOSE: The primary objective of this study is to investigate whether the addition of bevacizumab to lomustine improves overall survival (OS) in patients with recurrent glioblastoma compared to treatment with lomustine alone.

OBJECTIVES:

* To determine the therapeutic role of bevacizumab as well as the most favorable approach to treatment optimization for sequencing the combination of bevacizumab and lomustine in patients with glioblastoma multiforme in first recurrence.

OUTLINE: This is a multicenter study. Patients are stratified according to institution, WHO performance status (0 vs \> 0), steroid administration (yes vs no), and largest diameter of tumor (≤ 40 mm vs \> 40 mm). Patients are randomized at 2:1 ratio to 1 of 2 treatment arms.

* Arm 1: Lomustine 90 mg/m² every 6 weeks (cap. 160 mg) + bevacizumab 10 mg/kg every 2 weeks (at further progression treatment will be according to investigators discretion). In the absence of hematological toxicity \> grade 1 during the first cycle the dose of lomustine can be escalated to 110 mg/m² (cap 200 mg) in their second cycle.
* Arm 2 (control arm): Lomustine single agent 110 mg/m² every 6 weeks (cap. 200 mg) (at further progression treatment will be according to investigators discretion).

One cycle will be defined arbitrarily (due to the lomustine sequencing) as 6 weeks for all arms. Day 1 of a cycle will be the first day when medication is taken.

Previously collected blood and tumor tissue samples are analyzed for MGMT methylation status, isocitrate dehydrogenase 1, and biomarkers of the VEGF pathway.

Patients and their caregivers/relatives complete quality-of-life questionnaires (EORTC QLQ-C30 and EORTC-BN20) at baseline, at 12 weeks, and then every 12 weeks after completion of study therapy. Patients also undergo neurocognitive assessment at baseline, at 12 weeks, and then every 12 weeks after completion of study therapy.

After completion of study treatment, patients are followed every 12 weeks.

Bevacizumab and Lomustine for Recurrent GBM

Phase III Trial Exploring the Combination of Bevacizumab and Lomustine in Patients With First Recurrence of a Glioblastoma

Hoffmann-La Roche

European Organisation for Research and Treatment of Cancer - EORTC

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

A 6-week psycho-educationally-based, cognitive behavioral program to help patients with subjective cognitive complaints after cancer treatment, titled Emerging from the Haze™ (Haze). Each series meets once a week for 2-2.5 hours for 6 weeks.

A 6-week class designed to combat chemotherapy-induced cognitive dysfunction. Patients will report symptoms at 6 months and 1 year after the end of their Haze class.

Emerging from the Haze class

Arash Asher, MD

At Cedars-Sinai Medical Center, the investigators have developed a novel curriculum for a 6-week psycho-educationally-based, cognitive behavioral program to help patients with subjective cognitive complaints after cancer treatment, titled Emerging from the Haze™ (Haze). Each series meets once a week for 2-2.5 hours for 6 weeks.

The objective of this study is to quantify the impact of a trainee-taught Emerging from the Haze course on gynecologic cancer survivors' self-report of cognitive changes based on the change of FACT-Cog score.

Emerging From the Haze for Gynecologic Cancer Survivors

A Pilot Study of Emerging From the Haze Evaluating a Trainee-taught Psycho-educational Program to Improve Cancer-related Cognitive Complaints in Gynecologic Cancer Survivors

To compare the impact of a trainee-taught Emerging from the Haze course on gynecologic cancer survivors' self report of cognitive changes based on change of the FACT-Cog compared to the impact of an ongoing non-trainee-taught Emerging from the Haze course on breast cancer survivors' self report of cognitive changes based on the change in FACT-Cog score from first day of class (baseline) to last day of class (6 weeks) in these two groups

Measure the change in score from baseline to each of three time points: last day of class (6 weeks), 6 months, and 1 year after class

Cedars-Sinai Medical Center

Director of Cancer Rehabilitation and Survivorship

Cognitive rehabilitation

Martin JB Taphoorn, MD, PhD

Neil K Aaronson, PhD

Margriet M Sitskoorn, PhD

The purpose of this study is to determine whether cognitive rehabilitation is effective in patients with gliomas (brain tumour), by comparing direct and follow-up neuropsychological functioning and quality of life of the experimental group to the control group.

The majority of patients with (low-grade) glioma exhibit cognitive symptoms and objective deficits, which have a sustained, negative impact on daily functioning and quality of life.

Adult patients with a low-grade glioma, either histologically proven, or suspected (1), as well as adult anaplastic glioma patients with favorable prognostic factors (2), who are clinically stable for at least 6 months, will be recruited from 9 hospitals in the Netherlands. Consenting patients with both subjective cognitive symptoms and objective deficits will be randomized to either the cognitive rehabilitation program (N = 75) or a "waiting-list" control group (N = 75). Upon completion of the study, those patients assigned to the control group will be given the opportunity to undergo the cognitive rehabilitation program.

The cognitive rehabilitation program incorporates both retraining of impaired cognitive functions, and teaching of compensatory strategies. Rehabilitation will be directed towards attention, memory and executive functioning. The intervention will consist of 6 weekly, individual, 2-hour sessions plus two hours of homework.

To evaluate the efficacy of the rehabilitation program, objective neuropsychological functioning, self-reported cognitive symptoms and health-related quality of life will be assessed before rehabilitation, directly following rehabilitation, and at 6-month follow-up.

Cognitive Rehabilitation of Glioma Patients

Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study

Dutch Cancer Society

UMC Utrecht

Neoplasm Metastasis

Neoplastic Processes

Patients with pathologically proven solid tumour malignancy who have \>=4 brain metastases will be treated with gamma knife radiosurgery.

Depending on maximum tumour diameter, patients will receive a single dose of 15-20 Gy to the isodose surface which encompasses the entire metastasis.

Gamma knife radiosurgery

Harvey Quon, MD

Cancer which spreads to the brain (brain metastases) is a common and significant problem. Historically, whole-brain radiotherapy has been used to treat these patients but has a negative effect on cognition. Radiosurgery is an alternative treatment with potential for fewer cognitive side effects. The impact of radiosurgery alone on the cognitive function of patients with multiple brain metastases is not well studied. We propose a pilot study at the Winnipeg Centre for Gamma Knife Surgery to examine this issue.

Patients with \>=4 brain metastases will undergo Gamma Knife radiosurgery to a dose of 15-20 Gy, depending on the maximum tumour diameter and number of metastases. A number of neurocognitive, quality of life, and toxicity assessments will be performed at baseline and at 6 weeks post-radiosurgery, then at months 4, 6, 12, 18, and every 6 months thereafter.

Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

Other neurocognitive tests will include Trail making test A and B (TMT), Controlled Oral Word Association (COWAT), Test of Premorbid Functioning, Ruff Figural Fluency Test, Animal Naming, Brief Visuospatial Memory Test - Revised, WMS-III Digit Span, WMS-III Spatial Span, and the Symbol Digit Modalities Test.

* European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative (QLQ-C15-PAL)
* Brain cancer specific quality of life questionnaire (QLQ-BN20)

Health Sciences Centre Foundation, Manitoba

CancerCare Manitoba

Gland and Hormone Related Diseases

Cognitive Dysfunction

Prostatic Neoplasms

Testicular Neoplasms

Testosterone

Forty testicular cancer patients included after orchiectomy but prior to any further treatment.

Forty prostate cancer patients included prior to medical castration and radiotherapy.

Forty age- and education-matched healthy controls (20 matched to testicular cancer patients, 20 matched to prostate cancer patients).

Cecilie D R Clausen, MSc

Robert Zachariae, Professor, DMSc

The primary aim of the study is - in a prospective controlled design - to examine whether treatment-induced decreases in testosterone acts as a mechanism of cancer-related cognitive impairment (CRCI) in testicular and prostate cancer patients.

Secondary aims are 1) to explore whether decreases in testosterone interacts with increasing age to cause more severe CRCI in older patients, 2) to explore underlying neurophysiological (brain morphology) mechanisms of CRCI, and 3) to evaluate selected genetic variants as possible moderators of CRCI.

The study will include three groups with a total of 120 participants: A) Forty testicular cancer patients will be included and examined 1) shortly after orchiectomy and prior to any further treatment and 2) at 6 months' follow- up. B) Forty prostate cancer patients will be included and examined at two time-points: 1) prior to initiation of medical castration and radiotherapy and 2) at 6 months' follow- up. C) Forty age- and education-matched healthy controls will be included and assessed at a similar time-interval, i.e., at an initial examination and at a 6 month follow-up. Measures include a battery of neuropsychological/ cognitive tests, questionnaires, blood samples, and Magnetic Resonance Imaging (MRI).

Primary hypothesis

1. Treatment-induced decreases in testosterone will be associated with decline in global cognitive functioning from baseline to 6 months' follow- up in both testicular and prostate cancer patients.

   Secondary hypotheses
2. Treatment-induced decreases in testosterone will be associated with decline in individual cognitive domains (i.e., processing speed, attention, verbal fluency, executive functioning, working memory, verbal learning and memory, visuospatial learning and memory, and visuospatial ability) from baseline to 6 months' follow- up in both testicular and prostate cancer patients.
3. Decline in cognitive functioning from baseline to 6 months' follow- up in both testicular and prostate cancer patients will correspond to changes in grey matter as measured by T1-weighted MRI.
4. Decline in cognitive functioning from baseline to 6 months' follow- up in both testicular and prostate cancer patients will correspond to changes in brain white matter as measured with diffusion-weighted MRI.
5. Treatment-induced decreases in testosterone will be more strongly associated with decline in cognitive functioning in prostate cancer patients compared with testicular cancer patients due to more advanced age in the former group.
6. Treatment-induced decreases in testosterone will be more strongly associated with decline in cognitive functioning in both testicular and prostate cancer patients carrying the the Apolipoprotein E (APOE) ε4 allele, the Val catechol-O-methyltranferase (COMT) allele, the Val/Val Brain- derived neurotrophic factor (BDNF) genotype, and a short polymorphic CAG repeat length of the Androgen Receptor (AR) gene.
7. Treatment-induced decreases in testosterone will be associated with increases in neurobehavioral symptoms (i.e., apathy, executive dysfunction, and disinhibition) from baseline to 6 months' follow- up in both testicular and prostate cancer patients.
8. Treatment-induced decreases in testosterone will be associated with decreases in health-related quality of life from baseline to 6 months' follow- up in both testicular and prostate cancer patients.
9. Treatment-induced decreases in testosterone will be associated with decreases in perceived cognitive functioning from baseline to 6 months' follow- up in both testicular and prostate cancer patients.

Testosterone, Cognition, Ageing, and Cancer

Testosterone, Cognition, Ageing, and Cancer - A Controlled, Prospective Study About the Association Between Testosterone and the Prevalence and Severity of Cancer Related Cognitive Impairment in Testicular and Prostate Cancer Patients.

Changes in global cognitive composite score as measured with neuropsychological tests specified under "Secondary Outcome Measures".

Changes in visuospatial ability as measured with WAIS-IV Matrix Reasoning.

Changes in visuospatial ability as measured with WAIS-IV Figure Weights.

Changes in visuospatial ability as measured with WAIS-IV Visual Puzzles.

Changes in visuospatial ability as measured with WAIS-IV Block Design.

Changes in processing speed as measured with Trail Making Test A.

Changes in processing speed as measured with WAIS-IV Coding.

Changes in attention as measured with WAIS-IV Digit Span Forwards.

Changes in executive functioning as measured with Trail Making Test B.

Changes in executive functioning as measured with Wisconsin Card Sorting Test.

Changes in working memory as measured with WAIS-IV Digit Span Sequencing.

Changes in working memory as measured with WAIS-IV Digit Span Backwards.

Changes in verbal fluency as measured with Controlled Oral Word Association Test.

Changes in verbal learning and memory as measured with Hopkins Verbal Learning Test-Revised.

Changes in visuospatial learning and memory as measured with WMS-III Visual Memory.

Changes in testosterone levels as measured with liquid chromatography tandem mass spectrometry (LC-MS/MS).

Changes in grey matter as measured with T1-weighted MRI.

Changes in brain white matter as measured with diffusion-weighted MRI.

Genotype of the APOE gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphisms.

Genotype of the COMT gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphism.

Genotype of the BDNF gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphism.

CAG repeat lenght of the AR gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphism.

Changes in neurobehavioral symptoms as measured with The Frontal Systems Behavior Scale (FrsBe).

Changes in perceived cognitive functioning as measured with The Patient Assessment of Own Functioning Inventory (POAFI).

Changes in health-related quality of life as measured with The European Organization for Research and Treatment of Cancer, Quality of Life questionnaire for cancer patients (EORTC QLQ-C30).

Changes in disease specific health-related quality of life as measured with The European Organization for Research and Treatment of Cancer, Quality of Life Prostate Cancer Module (EORTC QLQ-PR25).

Changes in disease specific health-related quality of life as measured with The European Organization for Research and Treatment of Cancer, Quality of Life Testicular Cancer Module (EORTC QLQ-TC25).

Aarhus University Hospital

University of Aarhus

Skin and Connective Tissue Diseases

Substance Related Disorders

Breast Neoplasms

Polyneuropathies

Chemotherapy-Related Cognitive Impairment

Peripheral Nervous System Diseases

Neuromuscular Diseases

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

patients with ovarian cancer and paclitaxel + carboplatin combination chemotherapy as well as patients with breast cancer and paclitaxel +/- carboplatin combination chemotherapy

patients with benign gynecological tumors after laparoscopic surgical resection

patients with breast cancer with anti-hormonal and/or localized radiation treatment but no chemotherapy

standard combination chemotherapy (paclitaxel +/- carboplatin) if necessary according to treatment guidelines

Chemotherapy

Petra Huehnchen, Dr.

Neurotoxic phenomena are among the most common and difficult to treat side effects of chemotherapy. The development of chemotherapy induced peripheral neuropathy (CIPN) is a well-recognized adverse reaction in the peripheral nervous system. Side effects of chemotherapy in the central nervous system, however, particularly changes of cognitive function (in non-medical literature referred to as "chemobrain") are diffuse and difficult to attribute to individual cytostatic drugs. The primary purpose of this study is to assess cognitive function in patients with ovarian and breast cancer before and after systemic chemotherapy with paclitaxel with standardized neuropsychological tests and compare the outcome to patients with benign gynecological tumors and breast cancer without chemotherapy treatment, respectively. Secondary parameters include the assessment of olfactory function, total neuropathy score and cytokine profiles.

Primary outcome parameter:

compound score of standardized neuropsychological test

Secondary parameters:

* olfactory function (Sniffin Sticks)
* total neuropathy score (TNS), reduced version (clinical examination, neurography of sural and peroneal nerve)
* cytokine profiling from serum samples (ELISA)
* quality of life (questionnaire)
* depression screening (questionnaire)
* symptoms of polyneuropathy (questionnaire)
* symptoms of cognitive impairment (everyday memory test questionnaire)

Assessment time points:

* baseline (after surgical tumor resection and before chemotherapy)
* follow up 1 (3 weeks after last chemotherapy cycle or 21 weeks (control patients))
* follow up 2 (optional; 1 year after chemotherapy completion)

Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer

Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer (CICARO)

standardized neuropsychological test covering verbal memory, visual-spatial memory, short term/ working memory, executive functions

standardized test battery (Sniffin Sticks)

reduced version includes clinical examination and neurography of sural and peroneal nerve

Charite University, Berlin, Germany

resident and postdoctoral fellow

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Breast Diseases

Skin Diseases

Anti-Inflammatory Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Breast cancer patients treated with chemotherapy

Breast cancer patients not treated with chemotherapy

Women without a cancer diagnosis, matched for age and education

Kerstin Hermelink, PhD

The study will investigate the impact of cancer-related stress and its consequences (acute and posttraumatic stress symptoms, altered cortisol secretion) on cognitive function in breast cancer patients. The hypothesis that stress associated with the cancer diagnosis and the cancer treatment is a major cause of cognitive dysfunction in breast cancer patients shall be evaluated.

Primary hypothesis:

\*The adverse effects of cancer and cancer therapy on cognitive function in breast cancer patients are entirely or partly mediated by stress and the ensuing dysfunction of the HPA-axis.

Secondary objectives:

* Determining the effect of cancer diagnosis, chemotherapy, disease-related stress, acute stress response, posttraumatic stress disorder, posttraumatic stress symptoms, anxiety, and depression on the HPA-axis in breast cancer patients
* Determining the effect of cognitive dysfunction assessed with neuropsychological tests, cancer diagnosis, chemotherapy, disease-related stress, acute stress response, posttraumatic stress disorder, posttraumatic stress symptoms, anxiety, and depression on subjective cognitive function in breast cancer patients
* Prevalence of acute stress response, posttraumatic stress disorder and posttraumatic stress symptoms, and extent of cancer-specific stress in breast cancer patients treated with or without chemotherapy

Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress

Performance on a battery of cognitive tests

Cortisol awakening response and diurnal profile

Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bevacizumab and Lomustine for Recurrent GBM	NCT01290939	Glioblastoma Mu... Cognition Disor... Disability Eval...	bevacizumab lomustine DNA methylation... laboratory biom... cognitive asses... quality-of-life...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Bevacizumab and Lomustine for Recurrent GBM	NCT01290939	Glioblastoma Mu... Cognition Disor... Disability Eval...	bevacizumab lomustine DNA methylation... laboratory biom... cognitive asses... quality-of-life...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Bevacizumab and Lomustine for Recurrent GBM	NCT01290939	Glioblastoma Mu... Cognition Disor... Disability Eval...	bevacizumab lomustine DNA methylation... laboratory biom... cognitive asses... quality-of-life...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Emerging From the Haze for Gynecologic Cancer Survivors	NCT02918461	Gynecologic Neo... Cognition Disor...	Emerging from t...	18 Years -	Cedars-Sinai Medical Center
Cognitive Rehabilitation of Glioma Patients	NCT00256425	Glioma Cognition Disor...	Cognitive rehab...	18 Years - 70 Years	UMC Utrecht
Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases	NCT01970644	Neoplasm Metast...	Gamma knife rad...	18 Years -	CancerCare Manitoba
Testosterone, Cognition, Ageing, and Cancer	NCT03452436	Cancer-related ...		18 Years -	University of Aarhus
Cognitive Rehabilitation of Glioma Patients	NCT00256425	Glioma Cognition Disor...	Cognitive rehab...	18 Years - 70 Years	UMC Utrecht
Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer	NCT02753036	Cognition Disor... Polyneuropathie...	Chemotherapy	18 Years - 70 Years	Charite University, Berlin, Germany
Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases	NCT01970644	Neoplasm Metast...	Gamma knife rad...	18 Years -	CancerCare Manitoba
Testosterone, Cognition, Ageing, and Cancer	NCT03452436	Cancer-related ...		18 Years -	University of Aarhus
Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress	NCT01264562	Breast Cancer		18 Years - 65 Years	Ludwig-Maximilians - University of Munich
Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer	NCT02753036	Cognition Disor... Polyneuropathie...	Chemotherapy	18 Years - 70 Years	Charite University, Berlin, Germany

Spots Global Cancer Trial Database for cognition disorders