The Use Of Valeriana Officinalis (Valerian) In Improving Sleep In Patients Who Are Undergoing Adjuvant Treatment For Cancer" A Phase III Randomized, Placebo-Controlled, Double-Blind Study

NCT00075842 Phase 3 COMPLETED

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.

Details

Lead sponsor	Alliance for Clinical Trials in Oncology
Phase	Phase 3
Status	COMPLETED
Enrolment	227
Start date	2003-08
Completion	2010-01

Conditions

• Fatigue
• Sleep Disorders
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

• Valeriana officinalis extract
• placebo

Primary outcomes

• Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks — at 6 weeks

Countries

United States