Neoplasms

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Fallopian Tube Neoplasms

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Neoplasms by Histologic Type

Disease Attributes

Neuromuscular Diseases

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Urogenital Neoplasms

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Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Endometrial Neoplasms

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Neoplasms, Cystic, Mucinous, and Serous

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Micronutrients

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Vitamins

Acetylcarnitine

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Trace Elements

Carnitine

Folate

Vitamin B9

Patients receive ALC PO BID on days 1-21 (during chemotherapy treatment).

Patients receive placebo PO BID on days 1-21 (during chemotherapy treatment) (maximum of 8 courses).

Acetyl-L-Carnitine Hydrochloride

Placebo

Questionnaire Administration

Quality-of-Life Assessment

David Kushner

This randomized phase III trial studies how well acetyl-L-carnitine hydrochloride works compared to a placebo in preventing peripheral neuropathy in patients with recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer undergoing chemotherapy. Acetyl-L-carnitine hydrochloride may prevent or lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether acetyl-L-carnitine hydrochloride is more effective compared to a placebo in preventing peripheral neuropathy caused by chemotherapy.

PRIMARY OBJECTIVES:

I. Evaluate the therapeutic efficacy of acetyl-L-carnitine hydrochloride (ALC) in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer.

SECONDARY OBJECTIVES:

I. Evaluate the effect of ALC on chemotherapy-induced fatigue based upon the Functional Assessment of Cancer Therapy (FACT)-Fatigue scale.

II. Evaluate the effect of ALC on sensory peripheral neuropathy as measured with the first 4 items of the FACT/Gynecologic Oncology Group (GOG)-Neurotoxicity (Ntx) subscale (FACT/GOG-Ntx_4 subscale).

III. Evaluate the effect of ALC on the health-related quality of life as measured by the FACT-Ovarian (O) trial outcome index (TOI).

OUTLINE: This is a multicenter study. Patients are stratified according to planned dosage of paclitaxel (\< 150 mg/m\^2 vs ≥ 150 mg/m\^2), and age (\< 60 years of age vs ≥ 6 years of age). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive acetyl-L-carnitine hydrochloride (ALC) orally (PO) twice daily (BID) on days 1-21 (during chemotherapy treatment).

ARM II: Patients receive placebo PO BID on days 1-21 (during chemotherapy treatment) (maximum of 8 courses).

In both arms, treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients also complete questionnaires comprising the Functional Assessment of Cancer Therapy (FACT)-Fatigue scale, the FACT-Gynecologic Oncology Group Neurotoxicity subscale (FACT/GOG-Ntx_4 subscale), and the FACT-Ovarian trial outcome index (FACT-O TOI) at baseline, prior to courses 3 and 5, within 4 weeks after completion of treatment, and then at 3 months after completion of treatment.

Acetyl-L-Carnitine Hydrochloride in Preventing Peripheral Neuropathy in Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Undergoing Chemotherapy

A Randomized, Double-Blinded, Placebo Controlled Phase III Trial Using Acetyl-L-Carnitine(ALC)(NSC# 747431) for the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Patients With Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer

National Cancer Institute (NCI)

Gynecologic Oncology Group

Blood and Lymph Conditions

Immune System Diseases

Neoplasm Metastasis

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Lymphoma

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Methotrexate

Patients complete neurocognitive tests to assess thinking, memory, attention, and concentration. The baseline test is administered during the consolidation phase of chemotherapy and further tests are done at 1 year from baseline and 1 year after\* the completion of study therapy.

Patients undergo blood and cerebrospinal fluid collection periodically for biomarker, genotypic polymorphisms, and pharmacokinetic analysis. Patients undergo MRI diffusion-tensor imaging to correlate imaging with neuropsychological outcomes.

Cognitive Assessment

Diffusion Tensor Imaging

Laboratory Biomarker Analysis

Pharmacological Study

Psychosocial Assessment and Care

Naomi Winick

This clinical trial is looking at brain function in young patients receiving methotrexate for acute lymphoblastic leukemia. Learning about the long-term effects of methotrexate on brain function may help doctors plan cancer treatment.

OBJECTIVES:

I. Determine the neuropsychological function in children with acute lymphoblastic leukemia treated with either high-dose methotrexate or escalating-dose methotrexate in the absence of cranial radiation and nelarabine.

II. Identify host polymorphisms that predict an increased risk of neurocognitive dysfunction or acute neurotoxicity in these patients.

III. Correlate neuropsychological outcome measures and the occurrence of acute neurotoxicity with host polymorphisms in these patients.

IV. Measure concentrations of 5-methyltetrahydrofolate, homocysteine, Ado, S-adenosylmethionine, S-adenosylhomocysteine, and other potentially relevant compounds in serum and cerebrospinal fluid during interim maintenance therapy with low- or high-dose methotrexate regimens, respectively, and correlate these endpoints with the occurrence of acute neurologic toxicity and long-term neurocognitive dysfunction in these patients.

V. Determine whether or not diffusion tensor imaging will identify areas of selective vulnerability in CNS and provide an imaging modality that predicts and/or correlates with neuropsychological outcome.

OUTLINE: This is a prospective, cohort, multicenter study.

Patients complete neurocognitive tests to assess thinking, memory, attention, and concentration. The baseline test is administered during the consolidation phase of chemotherapy and further tests are done at 1 year from baseline and 1 year after\* the completion of study therapy.

Patients undergo blood and cerebrospinal fluid collection periodically for biomarker, genotypic polymorphisms, and pharmacokinetic analysis. Patients undergo MRI diffusion-tensor imaging to correlate imaging with neuropsychological outcomes.

NOTE: \* Within 8 months to 24 months after the completion of study therapy for patients on AALL0232.

Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia

A Study of Neurocognitive Function in Children Treated for ALL

Vocabulary and Block Design, subtests of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III), Wechsler Children Intelligence Scale (WISC-IV) and Wechsler Adult Intelligence Scale (WAIS-III) (based on age) will be used to estimate FSIQ, using the tables provided by Sattler.

Children's Oncology Group

Behaviors and Mental Disorders

Delirium

Confusion

Neurobehavioral Manifestations

Neurologic Manifestations

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Anticonvulsants

Antiemetics

Central Nervous System Depressants

Psychotropic Drugs

Gastrointestinal Agents

Anti-Dyskinesia Agents

Cardiotonic Agents

Lorazepam

Haloperidol

Haloperidol decanoate

Antipsychotic Agents

Dopamine

Dopamine Antagonists

Dopamine Agents

Neurotransmitter Agents

Hypnotics and Sedatives

Anti-Anxiety Agents

GABA Modulators

Participants given a single dose of lorazepam 3 mg by vein, in addition to a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete

Participants receive placebo, preservative free 0.9% normal saline, by vein plus a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete

Placebo consisting of preservative free 0.9% normal saline given one time by vein.

Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete.

Questionnaires

David Hui, MD

This randomized phase II trial studies how well haloperidol with or without lorazepam works in reducing confusion, disorientation, and inability to think or remember clearly (delirium) in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Palliative therapy with haloperidol and lorazepam may reduce symptoms of delirium and help patients with advanced cancer live more comfortably. It is not yet known whether lorazepam may be an effective treatment for delirium when given with haloperidol.

PRIMARY OBJECTIVES:

I. To compare the effect of single dose lorazepam and placebo as an adjuvant to haloperidol on the intensity of agitation (Richmond Agitation Sedation Scale) over 8 hours.

II. To assess the within-arm effect of single-dose lorazepam or placebo, as an adjuvant agent with haloperidol, on agitation intensity (Richmond Agitation Sedation Scale) over 8 hours in patients admitted to an acute palliative care unit.

SECONDARY OBJECTIVES:

I. To compare the effect of single dose lorazepam and placebo as an adjuvant to haloperidol on (1) delirium related distress in nurses and caregivers, (2) delirium duration, (3) need for rescue doses of neuroleptics, (4) delirium recall, (5) symptom expression (Edmonton Symptom Assessment Scale), (6) communicative capacity, (7) adverse effects, (8) discharge outcomes, and (9) survival in cancer patients.

II. To evaluate proportion of patients who consent and are randomized to study however drop out before being treated or before finishing 8-hour Richmond Agitation Sedation Scale (RASS) assessment; and the reasons of drop-outs will be documented and reported.

III. To explore the changes in biomarker levels in saliva samples (salivary cortisol, cholinesterase, C-reactive protein, interleukin-1 beta, -6, and -10) over time and in association with delirium severity.

IV. To examine the inter-rater reliability of RASS in the Acute Palliative Care Unit (APCU) setting between the bedside nurse and the research nurse at the time of study enrollment.

V. To conduct exploratory analyses on RASS as an outcome. VI. To examine the association among rescue medication use, RASS and perceived comfort by the nurses and caregivers.

VII. To examine the proportion of patients enrolled onto the delirium trial who achieved control of agitation and did not require the randomized study medication.

VIII. To identify patient factors associated with control of agitated delirium.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive lorazepam intravenously (IV) over 1-2 minutes and haloperidol IV every 6 hours or every 1 hour if needed.

ARM II: Patients receive placebo IV over 1-2 minutes and haloperidol IV every 6 hours or every 1 hour if needed.

Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer

A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit

The primary outcome was change in Richmond Agitation-Sedation Scale score from baseline to 8 hours after treatment administration. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.

Absolute score of Richmond Agitation-Sedation Scale at 8 hr, points. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.

Change in Richmond Agitation-Sedation Scale score from baseline to 30 min. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.

Number of participants with Richmond Agitation-Sedation Scale score \>=1 within 8 hr. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.

M.D. Anderson Cancer Center

UKU (Udvalg for Kliniske Undersøgelser ) Adverse events Assessment. Total intent to treat = 58 (29+29); Total Participants used for the All Cause Mortality in both Arms, Intervention (47), and Placebo (43). The total number of deaths in the Intervention Group were 10 which includes 9 from the incomplete category and 1 from the complete category. The total number of deaths in the Control Group were 10 which includes 7 from the incomplete category and 3 from the complete category.

Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)

Intervention Group (Lorazepam & Haloperidol)

Received single dose of Haloperidol (2mg IV, once)

Control Group (Placebo & Haloperidol)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

High School or less

College

Completed College

Not Available

Education

Metastatic Cancer

Locally advanced

Recurrent or Persistent

Cancer Stage

GastroIntestinal Cancer

Hematological Cancer

Genitourinary

Head and neck

Breast

Respiratory Cancer

Gynecological

Other

Cancer Type

The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities.

Karnofsky performance status

Intent to treat analysis of 58 participants, 29 for each arm

David Hui, MD/ Associate Professor, Palliative Care Medicine

Intent to treat 58 participants, a total of 29 for each arm; 3 participants were lost to follow up from each arm.

Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points

Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points

Intent to treat 58 participants, a total of 29 for each arm

Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min

Intent to treat 58 participants, a total of 29 from each arm

Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr

Overall Study

Digestive System Diseases

Peritoneal Neoplasms

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Acetyl-L-Carnitine Hydrochloride in Preventing Peripheral Neuropathy in Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Undergoing Chemotherapy	NCT01492920	Fatigue Malignant Ovari... Neuropathy Neurotoxicity S... Ovarian Brenner... Ovarian Clear C... Ovarian Endomet... Ovarian Mucinou... Ovarian Serous ... Pain Recurrent Fallo... Recurrent Ovari... Recurrent Prima...	Acetyl-L-Carnit... Placebo Questionnaire A... Quality-of-Life...	18 Years -	GOG Foundation
Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia	NCT00437060	Childhood B Acu... Childhood T Acu... Cognitive Side ... Long-Term Effec... Neurotoxicity S... Psychological I... Untreated Child...	Cognitive Asses... Diffusion Tenso... Laboratory Biom... Pharmacological... Psychosocial As...	1 Year - 17 Years	Children's Oncology Group
Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer	NCT01949662	Advanced Cancer...	Lorazepam Placebo Haloperidol dec... Questionnaires	18 Years -	M.D. Anderson Cancer Center
Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer	NCT02311907	Chemotherapeuti... Neuropathy Neurotoxicity S... Pain Stage IIIA Fall... Stage IIIA Ovar... Stage IIIA Prim... Stage IIIB Fall... Stage IIIB Ovar... Stage IIIB Prim... Stage IIIC Fall... Stage IIIC Ovar... Stage IIIC Prim... Stage IV Fallop... Stage IV Ovaria... Stage IV Primar...	Carboplatin Glutathione Laboratory Biom... Paclitaxel Placebo Quality-of-Life...	18 Years -	Alliance for Clinical Trials in Oncology
Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer	NCT00807768	Endometrial Cle... Endometrial Ser... Fatigue Neurotoxicity S... Obesity Stage I Uterine... Stage II Uterin...	3-Dimensional C... Carboplatin Intensity-Modul... Internal Radiat... Laboratory Biom... Paclitaxel Quality-of-Life... Questionnaire A...	18 Years -	GOG Foundation
Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer	NCT01949662	Advanced Cancer...	Lorazepam Placebo Haloperidol dec... Questionnaires	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for neurotoxicity syndrome