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Safety and Efficacy of ALC in Breast Cancer in Subjects With Fatigue

NCT ID: NCT00555841

Last Updated: 2012-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-09-30

Brief Summary

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The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant radiotherapy.

Detailed Description

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The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant radiotherapy

Conditions

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Breast Cancer

Keywords

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breast cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALC

I g three times daily

Group Type EXPERIMENTAL

ALC and Placebo

Intervention Type DRUG

ALC and Placebo

Placebo

1 g three times daily

Group Type PLACEBO_COMPARATOR

ALC and Placebo

Intervention Type DRUG

ALC and Placebo

Interventions

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ALC and Placebo

ALC and Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stage 0-III breast cancer in which adjuvant radiation is indicated;
* Qualifying Brief Fatigue Inventory (BFI) score 6. -

Exclusion Criteria

* Medication to treat or manage fatigue and pain
* Use of erythropoietin to control anemia
* Clinical evidence of hypothyroidism or hyperthyroidism
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sigma-Tau Research, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen Escalante, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas MD Anderson Cancer Center

Locations

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The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ST 03-103

Identifier Type: -

Identifier Source: org_study_id