NCT00555841

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

March 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

August 28, 2012

Status Verified

August 1, 2012

Enrollment Period

1.5 years

First QC Date

November 7, 2007

Last Update Submit

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

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:

  • 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.

Sponsors & Collaborators

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

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

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 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

August 28, 2012

Record last verified: 2012-08

Locations

US(1)