Patients will receive prophylactic ACE-I(Capoten®) at day 1 of initiation of chemotherapy and is to be continued for 1 year after the end of treatment. Patients will remain on this arm until they experience any of the study primary or secondary end-point where they will be off-study and will receive cardiotoxicity treatment independently.

Patients will not receive ACE-I as prophylaxis, and will be monitored and evaluated for first signs of cardiotoxicity based on the above mentioned end-points.

Cardiotoxicity

Acute Myeloid Leukemia in Children

Bone Tumor

ACE-I (Capoten®) will be given to patients in the Intervention arm with the start of chemotherapy, twice daily at a dose of 0.5 mg/kg/day (divided over 2 doses)

Capoten®

Children's Cancer Hospital Egypt 57357 Cairo, Egypt

Prevention of Chemotherapy Induced Cardiotoxicity in Children With Bone Tumors and Acute Myeloid Leukemia

ALL patients will be subjected to the following cardiac imaging ( TTE, TDI, STE) at the each time intervals of the study.
Plasma troponin I (TnI) concentration will be measured for all the patients at the each time intervals of the study.

Troponin I (TnI) concentration is to be determined by a fluorometric enzyme immunoassay analyzer (Stratus CS, Dade Behring, Miami, Fla) with a functional sensitivity of 0.03 g/L; the cutoff level was 0.08 ng/mL.
Plasma troponin I (TnI) concentration will be measured in both groupsas follows :
Early TnI: TnI concentration will be measured before and soon after each cycle of HDC. Determination of early TnI consists of a curve of assays (2ml blood sample): baseline initially, before & after immediately, and 12 and 24 hours after the end of Anthracycline chemotherapy infusion.This sequence will be repeated with each cycle of therapy containing Anthracycline. For each patient, the highest TnI value will be considered for each chemotherapy cycle.
Late TnI: TnI value also is to be determined at the end of treatment and 2, 3, 6, and 12 months after end of treatment in both groups.

Patients will be evaluated Clinically for cardiac functions using ECG , conventional echo, Tissue Doppler Imaging (TDI) and SpeckelTracking Echocardiography STE , before each chemotherapy cycle maximum one week given

Children's Cancer Hospital Egypt 57357

This is a prospective randomized study where all patients presenting to the CCHE with de novo diagnosis of Bone tumor (ES and OS) and AML will be randomized to receive (Intervention arm) or not to receive (Control arm) prophylactic ACE-I with the start of chemotherapy.

Breast Cancer Female

Neuropathic Pain

Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer

Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer : A Prospective Observational Study

CIPN-related pain is defined as - neuropathic pain as a result of chemotherapy induced nerve damage .
All patients (who fulfill the inclusion criteria) visiting Tata Memorial Hospital during Feb2017 to Jun2017will be examined in the Medical Oncology OPD by one of the investigators and the current CIPN-related pain score will be documented by using the LANSS scale.
LANSS score>12 will be considered as possible CIPN-related pain for statistical analysis

CIPN defined as - neuropathy symptoms (other than pain) as a result of chemotherapy induced nerve damage .
All patients (who fulfill the inclusion criteria) visiting Tata Memorial Hospital during Feb2017 to Jun2017will be examined in the Medical Oncology OPD by one of the investigators and the current CIPN score will be documented by using the NCI-CTCAE v4.0 grading.
Paclitaxel induced CIPN is defined as NCI-CTCAE Grade 2 or above for statistical analysis

The distribution, appearance and disappearance of syptoms related to CIPN will be based on special questionnaire.

Use of 1. Acetyl-L-carnitine (ALC) 2. Amifostine 3. Amitriptyline 4. CaMg 5. Diethyldithio-carbamate (DDTC) 6. Glutathione (GSH) 7. Nimodipine 8. All-trans-retinoic acid 9. rhuLIF 10. Vitamin E during Paclitaxel chemotherapy will be noted based on history and examination of charts

Parmanand Jain

Professor, Anaesthesiology, Critical Care & Pain. Head, Division of Pain.

Tata Memorial Centre

Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks.

Patients receive oral placebo 3 times daily for 24 weeks.

Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks

Arm I (Acetyl-L-carnitine Hydrochloride))

Patients receive oral placebo 3 times daily for 24 weeks

Arm II (Placebo)

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
- Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
- Symptomatic, <50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities.

Zubrod Performance Status

As per AJCC 6th ed, 2002:
https://cancerstaging.org/references-tools/deskreferences/Documents/AJCC6thEdCancerStagingManualPart2.pdf

Breast cancer stage

Taxane regiment

Compare whether treatment with acetyl-L-carnitine hydrochloride vs placebo prevents symptoms of neuropathy as measured by the 11-item neurotoxicity (NTX) component of the Functional Assesment of Cancer Therapy (FACT)-Taxane Questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse CIPN. Total possible range is 0 to 64. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires

12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups

Compare FACT-TOI outcome in treatment vs placebo groups at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse functional status. Total possible range is 0 to 120. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires

12-week FACT-Trial Outcome Index(TOI) Functional Status Model-adjusted Score in ALC and Placebo Groups

Compare fatigue outcome between treatment and placebo groups as measured by the 13-item Functional Assessment of Chronic Illness Therapy FACIT-fatigue questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate more fatigue. Total possible range is 0 to 52. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires

12-week FACIT-fatigue Model-adjusted Score in ALC and Placebo Groups

Proportion of patients experiencing grade 3 or 4 neuropathy

Proportion of Patients Experiencing Grade 3 or 4 Neuropathy

Serum Nerve Growth Factor Levels

total dose of taxane received and treatment delays, compliance with therapy, and use of concurrent medications, dietary supplements (e.g., glutamine), vitamin E, and complementary and alternative medicines

Treatment and Concurrent Therapy

Explore the relationship between nerve growth factor levels and the degree of neuropathy and functional status in these patients.

Association Between Nerve Growth Factor Levels and the Degree of Neuropathy and Functional Status

Explore the relationship between genetic markers responsible for taxane metabolism and clearance (e.g., CYP2C8, CYP3A4, CYP3A5, GSTM1, and GSTP1) and the degree of neuropathy in these patients.

Association Between Genetic Markers Responsible for Taxane Metabolism and Clearance and the Degree of Neuropathy

Overall Study

Study Statistician

Breast Cancer

Chemotherapeutic Agent Toxicity

Fatigue

Neuropathy

Neurotoxicity

acetyl-L-carnitine hydrochloride

placebo

Providence Cancer Center at Providence Hospital

Alaska Regional Hospital Cancer Center

Providence Cancer Center

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Kaiser Permanente - Deer Valley

Alta Bates Summit Comprehensive Cancer Center

Peninsula Medical Center

East Bay Radiation Oncology Center

Eden Medical Center

Valley Medical Oncology Consultants - Castro Valley

Kaiser Permanente - Fremont

Valley Medical Oncology

Glendale Memorial Hospital Comprehensive Cancer Center

Kaiser Permanente Medical Center - Hayward

USC/Norris Comprehensive Cancer Center and Hospital

Contra Costa Regional Medical Center

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

El Camino Hospital Cancer Center

Highland General Hospital

Alta Bates Summit Medical Center - Summit Campus

Bay Area Breast Surgeons, Incorporated

CCOP - Bay Area Tumor Institute

Larry G Strieff MD Medical Corporation

Tom K Lee, Incorporated

Kaiser Permanente Medical Center - Oakland

Valley Care Medical Center

Valley Medical Oncology Consultants - Pleasanton

Kaiser Permanente Medical Center - Redwood City

Kaiser Permanente Medical Center - Richmond

Kaiser Permanente Medical Center - Roseville

Sutter Cancer Center at Roseville Medical Center

Sutter Cancer Center

University of California Davis Cancer Center

South Sacramento Kaiser-Permanente Medical Center

Kaiser Permanente Medical Center - Sacramento

Kaiser Permanente Medical Center - San Francisco Geary Campus

California Pacific Medical Center - California Campus

Kaiser Permanente Medical Center - Santa Teresa

Doctors Medical Center - San Pablo Campus

Kaiser Foundation Hospital - San Rafael

Sutter Health - Western Division Cancer Research Group

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Kaiser Permanente Medical Center - Santa Rosa

Kaiser Permanente Medical Center - South San Francisco

Kaiser Permanente Medical Facility - Stockton

Tahoe Forest Cancer Center

Kaiser Permanente Medical Center - Vacaville

Kaiser Permanente Medical Center - Vallejo

Sutter Solano Medical Center

Kaiser Permanente Medical Center - Walnut Creek

San Luis Valley Regional Medical Center

University of Colorado Cancer Center at UC Health Sciences Center

Denver Health Medical Center

Kaiser Permanente - Denver

Shaw Regional Cancer Center

Poudre Valley Hospital

Valley View Hospital Cancer Center

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Kaiser Permanente - Lafayette

Montrose Memorial Hospital Cancer Center

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Piedmont Hospital

Northside Hospital Cancer Center

Saint Joseph's Hospital of Atlanta

CCOP - Atlanta Regional

WellStar Cobb Hospital

John B. Amos Cancer Center

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Northeast Georgia Medical Center

Gwinnett Medical Center

Kennestone Cancer Center at Wellstar Kennestone Hospital

Southern Regional Medical Center

Harbin Clinic Cancer Center - Medical Oncology

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Pearlman Comprehensive Cancer Center at South Georgia Medical Center

Kapiolani Medical Center at Pali Momi

Cancer Research Center of Hawaii

OnCare Hawaii, Incorporated - Lusitana

Queen's Cancer Institute at Queen's Medical Center

Straub Clinic and Hospital, Incorporated

Hawaii Medical Center - East

OnCare Hawaii, Incorporated - Kuakini

Kaiser Permanente - Moanalua Medical Center and Clinic

Kapiolani Medical Center for Women and Children

Tripler Army Medical Center

Pacific Cancer Institute - Maui

Saint Anthony's Hospital at Saint Anthony's Health Center

Cancer Care Center of Decatur

Decatur Memorial Hospital Cancer Care Institute

Crossroads Cancer Center

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Good Samaritan Regional Health Center

Edward Hospital Cancer Center

Regional Cancer Center at Memorial Medical Center

St. Francis Hospital and Health Centers - Beech Grove Campus

Reid Hospital & Health Care Services

Genesis Regional Cancer Center at Genesis Medical Center

Genesis Medical Center - West Campus

Cancer Center of Kansas, PA - Chanute

Cancer Center of Kansas, PA - Dodge City

S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, II, or IIIA Breast Cancer Undergoing Chemo

S0715: Randomized Placebo-Controlled Trial of Acetyl-L-Carnitine (ALC) for the Prevention of Taxane Induced Neuropathy Phase III

Southwest Oncology Group

National Cancer Institute (NCI)

Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.

Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.

Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
L-carnitine L-tartrate: Given orally

Arm I

Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
placebo: Given orally

Arm II

Race and Ethnicity Not Collected

Region of Enrollment

Data was not analyzed due to study termination

Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork

Dr. Alice Shapiro

Arm I L-Carnitine

Arm II-Placebo

L-carnitine L-tartrate

Masonic Cancer Center at University of Minnesota

Park Nicollet Cancer Center

L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer

Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Metastatic Breast Cancer

HealthPartners Institute

Heart Failure

Patients will be randomized to L-carnitine therapy or placebo. Patients in the treatment group will receive oral L-carnitine (3 grams daily) for 3 days prior to chemotherapy, 1 gram of intravenous L-carnitine (5 cc over 5 minutes, prior to chemotherapy) on the day of chemotherapy and oral L-carnitine (3 grams daily) for 3 days after chemotherapy.

L-carnitine

University of Ottawa Heart Institute

Ability of L-carnitine to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy

Primary Prevention of Anthracycline-Induced Cardiotoxicity With L-Carnitine in Patients With Breast Cancer (PPACC)-Pilot Study

carnitine/kanker payudara

Prevention of Chemotherapy Induced Cardiotoxicity in Children With Bone Tumors and Acute Myeloid Leukemia

Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer

S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, II, or IIIA Breast Cancer Undergoing Chemo

L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer

Ability of L-carnitine to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy

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