deltatrials
Terminated PHASE2 INTERVENTIONAL 2-arm NCT00555841

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

Safety and Efficacy of Oral Acetyl-l-carnitine (ALC) in Non-anemic Potentially Curable Breast Cancer Subjects Undergoing Adjuvant Radiation Therapy Who Have Moderate to Severe Fatigue

Sponsor: Sigma-Tau Research, Inc.

Conditions Breast Cancer
Interventions ALC and Placebo
Updated 6 times since 2017 Last updated: Aug 27, 2012 Started: Mar 31, 2007 Primary completion: Sep 30, 2008 Completion: Sep 30, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Sponsor decision

A PHASE2 clinical study on Breast Cancer, this trial is terminated or withdrawn. The trial is conducted by Sigma-Tau Research, Inc. and has accumulated 6 data snapshots since 2007. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE2

  5. Feb 2017 — Jun 2018 [monthly]

    Terminated PHASE2

Show 1 earlier version
  1. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE2

    First recorded

Mar 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Sigma-Tau Research, Inc.
Data source: Sigma-Tau Research, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations