NCT00775645|CompletedPhase 3ResultsDMC

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

SWOG Cancer Research Network ClinicalTrials.gov

Compare

3 other identifiers

CDR0000617081S0715U10CA037429

Study Type

interventional

Target

437

Locations

1 country

Sites

295

Timeline

RegisteredOct 2008

StartedSep 2009

CompletionJun 2013

Brief Summary

RATIONALE: Acetyl-L-carnitine may prevent or lessen neuropathy caused by chemotherapy. It is not yet known whether acetyl-L-carnitine is more effective than a placebo in preventing neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying acetyl-L-carnitine to see how well it works compared with a placebo in preventing neuropathy in women with stage I, stage II, or stage III breast cancer undergoing chemotherapy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

437

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline

Completed

Started Sep 2009

Geographic Reach

1 country

295 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

First Submitted

Initial submission to the registry

October 17, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed

11 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed

3.9 years until next milestone

Results Posted

Study results publicly available

April 10, 2017

Completed

Last Updated

August 14, 2017

Status Verified

June 1, 2017

Enrollment Period

2.3 years

First QC Date

October 17, 2008

Results QC Date

November 14, 2016

Last Update Submit

June 29, 2017

Conditions

Breast Cancer Chemotherapeutic Agent Toxicity Fatigue Neuropathy Neurotoxicity

Keywords

neurotoxicitychemotherapeutic agent toxicityfatigueneuropathystage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

Other Outcomes (5)

Proportion of Patients Experiencing Grade 3 or 4 Neuropathy
12 weeks post-registration
Serum Nerve Growth Factor Levels
12 weeks post-registration
Treatment and Concurrent Therapy
12 weeks post-registration
+2 more other outcomes

Study Arms (2)

Arm I

EXPERIMENTAL

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

Dietary Supplement: acetyl-L-carnitine hydrochloride

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo 3 times daily for 24 weeks.

Other: placebo

Interventions

acetyl-L-carnitine hydrochlorideDIETARY_SUPPLEMENT

Given orally

Arm I

placeboOTHER

Given orally

Arm II

Eligibility Criteria

Age18 Years - 120 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed primary invasive adenocarcinoma of the breast * Stage I-III disease * No metastatic disease * Must have undergone modified radical mastectomy or breast-sparing surgery * Planning to receive one of the following standard taxane-based systemic chemotherapy regimens as adjuvant therapy for breast cancer: * Paclitaxel 80 mg/m² weekly for 12 weeks * Paclitaxel 175 mg/m² every other week for 4 courses (8 weeks) * Paclitaxel 175 mg/m² every other week for 6 courses (12 weeks) * Docetaxel 75 mg/m² every 3 weeks for 4 courses (12 weeks) * Docetaxel 75 mg/m² every 3 weeks for 6 courses (18 weeks) * No history of neuropathy * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Zubrod performance status 0-2 * Serum creatinine ≤ 2.5 times upper limit of normal * Not pregnant or nursing * Fertile patients must use effective contraception * Able to complete questionnaires in English or Spanish * Willing to submit blood samples for DNA extraction, genotyping analysis, and nerve growth factor studies * No history of diabetes * No history of seizure disorder * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, ductal carcinoma in situ, or adequately treated stage I or stage II malignancy from which the patient is currently in complete remission PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior breast surgery * Prior neoadjuvant or adjuvant chemotherapy allowed * No prior taxane therapy * No prior biologic therapy for treatment of breast cancer * No concurrent vitamin E, glutamine, gabapentin, nortriptyline, amitriptyline, or duloxetine hydrochloride * Multivitamins containing vitamin E allowed provided vitamin E dose is \< 1,000 IU * No concurrent anti-seizure medications * Concurrent hormonal therapy allowed * Concurrent biologic therapy allowed (e.g., Herceptin) * Concurrent participation in another therapeutic clinical trial allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (295)

Providence Cancer Center at Providence Hospital

Mobile, Alabama, 36608, United States

Location

Alaska Regional Hospital Cancer Center

Anchorage, Alaska, 99508, United States

Location

Providence Cancer Center

Anchorage, Alaska, 99508, United States

Location

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, 99701, United States

Location

Kaiser Permanente - Deer Valley

Antioch, California, 94531, United States

Location

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Peninsula Medical Center

Burlingame, California, 94010, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Eden Medical Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

Kaiser Permanente - Fremont

Fremont, California, 94538, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

Glendale Memorial Hospital Comprehensive Cancer Center

Glendale, California, 91204, United States

Location

Kaiser Permanente Medical Center - Hayward

Hayward, California, 94545, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, 95901, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus