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NCT00075842 · ClinicalTrials.gov registry record · Phase 3

(Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy

A Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Fatigue, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 3
Development phase
227
Enrollment target
20
Study locations

NCT00075842 is a Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Fatigue that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 227 participants, below the 498-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 4 states.

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The verdict

NCT00075842, a Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Fatigue, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 3
Development phase
227 participants
Enrollment target
20
Study locations

Study Summary

RATIONALE: The herb Valeriana officinalis (valerian) may promote sleep. It is not yet known whether valerian is effective in improving sleep in patients who are receiving adjuvant therapy for cancer. PURPOSE: This randomized phase III trial is studying how well valerian improves the quality of sleep in patients who are receiving adjuvant therapy (radiation therapy, chemotherapy, or hormone therapy) for cancer.

Interventions

  • OTHER placebo
  • DIETARY_SUPPLEMENT Valeriana officinalis extract

Study Locations (20)

Colorado

  • Aurora Presbyterian Hospital - Aurora
  • Boulder Community Hospital - Boulder
  • Penrose Cancer Center at Penrose Hospital - Colorado Springs
  • Porter Adventist Hospital - Denver
  • Presbyterian - St. Luke's Medical Center - Denver
  • St. Joseph Hospital - Denver
  • Rose Medical Center - Denver
  • CCOP - Colorado Cancer Research Program - Denver
  • Swedish Medical Center - Englewood
  • Sky Ridge Medical Center - Lone Tree
  • Hope Cancer Care Center at Longmont United Hospital - Longmont
  • St. Mary - Corwin Regional Medical Center - Pueblo
  • North Suburban Medical Center - Thornton

Iowa

  • Mercy Cancer Center at Mercy Medical Center - North Iowa - Mason City
  • Siouxland Hematology-Oncology Associates, LLP - Sioux City
  • St. Luke's Regional Medical Center - Sioux City

Minnesota

  • Fairview Ridges Hospital - Burnsville
  • Mercy and Unity Cancer Center at Mercy Hospital - Coon Rapids
  • Fairview Southdale Hospital - Edina

Kansas

  • CCOP - Wichita - Wichita

Trial Details

FieldValue
Enrollment Target 227 participants
Start Date 2003-08
Est. Completion 2010-01
Phase Phase 3

What the Registry Record Tells You About NCT00075842

The ClinicalTrials.gov registry entry for NCT00075842 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 227 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 498-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (54% lower). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Unspecified Adult Solid Tumor, Protocol Specific appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT00075842 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Colorado, Iowa, Minnesota.

Frequently Asked Questions

What is clinical trial NCT00075842 about?

NCT00075842 is a clinical study titled "(Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy". RATIONALE: The herb Valeriana officinalis (valerian) may promote sleep. It is not yet known whether valerian is effective in improving sleep in patients who are receiving adjuvant therapy for cancer. PURPOSE: This randomized phase III trial is studying how well valerian improves the quality of slee...

What is the current status of trial NCT00075842?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 227 participants. The study started on 2003-08. Estimated completion is 2010-01.

What conditions does trial NCT00075842 study?

This clinical trial studies the following conditions: Unspecified Adult Solid Tumor, Protocol Specific, Fatigue, Sleep Disorders.

What interventions are being tested in trial NCT00075842?

The interventions under investigation include: placebo (OTHER), Valeriana officinalis extract (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00075842?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00075842 being conducted?

This trial has 20 study locations across Colorado, Iowa, Kansas, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.