Safety and Efficacy of ALC in Breast Cancer in Subjects W... | NCT00555841

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

NCT00555841

Sponsor

Sigma-Tau Research, Inc.

Status

Terminated

Last Update Posted

Aug 28, 2012Estimated

Enrollment

27Actual

Phase

Phase 2

Conditions

Breast Cancer

Interventions

ALC and Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Nov 7, 2007

First Submission Date that Met QC Criteria

Nov 8, 2007

First Posted Date

Nov 9, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2012

Last Update Posted Date

Aug 28, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALC	Experimental	I g three times daily	Drug: ALC and Placebo
Placebo	Placebo Comparator	1 g three times daily	Drug: ALC and Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALC and Placebo	Drug	ALC and Placebo	ALC Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of BFI as evaluated from Baseline to Final Visit		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carmen Escalante, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas MD Anderson Cancer Center		Houston	Texas	77030	United States

Type	Date	Date Unknown
Release	Dec 4, 2013
Unrelease		Yes
Release	Dec 20, 2013
Reset	Feb 13, 2014

Submission Tracking

Estimated Results First Submitted Date

Dec 4, 2013

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 4, 2013		Yes
Dec 20, 2013

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C019658	allantoicase

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided