NCT00555841

TerminatedPhase 2

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

Sigma-Tau Research, Inc.Source

Sigma-Tau Research, Inc.ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

ST 03-103

Study Type

interventional

Actual enrollment (reported)

27

Locations

1 country

Sites

1

Timeline

Study Start

March 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2008

Actual (reported)

Study Completion

September 2008

Actual (reported)

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 27 participants
Study completion date: September 2008
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 7, 2007
Actual (reported)
First Posted
November 9, 2007
Actual (reported)
Primary Completion
September 2008
Actual (reported)
Study Completion
September 2008
Actual (reported)

Last Updated: August 28, 2012
Status Verified: August 2012
Last Update Submitted: August 27, 2012

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

Change of BFI as evaluated from Baseline to Final Visit
16 weeks

Secondary Outcomes (1)

Changes in Health-Related Quality of Life (HQoL) outcomes using Medical Outcomes Study Short Form Health Status Profile 12 items (MOS-SF 12
16 weeks

Study Arms (2)

ALC

EXPERIMENTAL

I g three times daily

Drug: ALC and Placebo

Placebo

PLACEBO COMPARATOR

1 g three times daily

Drug: ALC and Placebo

Interventions

ALC and PlaceboDrug

ALC and Placebo

ALCPlacebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

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

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Sigma-Tau Research, Inc.
Industrylead

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

MeSH Terms

Conditions

Breast Neoplasms

Interventions

allantoicase

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Carmen Escalante, MD
M.D. Anderson Cancer Center
PRINCIPAL INVESTIGATOR

Enrollment

27 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 9, 2007

Study Start

March 2007

Date type not reported

This date has not been verified as actual or estimated.

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Phase 2Completed

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Phase 2Completed

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

Contact the study team to confirm eligibility.

Primary Completion

September 2008

Actual (reported)

Study Completion

September 2008

Actual (reported)

Last Updated

August 28, 2012

Record last verified: 2012-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00555841
Data provider: ClinicalTrials.gov
Source updated: 2012-08-28
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:51 UTC

Locations

US(1)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

ALC

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

ALC

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations