Completed

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

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What is being tested

Valeriana officinalis extract

+ placebo

Dietary SupplementOther
Who is being recruted

Mental Disorders+3

+ Fatigue

+ Nervous System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-ControlledPhase 3
Interventional
Study Start: August 2003
See protocol details

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2003

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the effect of Valeriana officinalis (Valerian) for improving the quality of sleep in patients with cancer receiving adjuvant therapy. Secondary * Determine the safety of this therapy, in terms of frequency and severity of adverse events, in these patients. * Determine the effect of this therapy on the degree of anxiety, fatigue, and activities of daily living in these patients. OUTLINE: This is a double-blind, placebo-controlled, randomized, multicenter study. Patients are stratified according to type of adjuvant treatment (radiotherapy vs parenteral chemotherapy vs oral therapy vs combined modality), age (40 and under vs 41 to 55 vs 56 to 70 vs over 70), and numerical analogue scale for sleep difficulty (mildly impaired sleep quality \[4-7\] vs moderate or severely impaired sleep quality \[8-10\]). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks. * Arm II: Patients receive an oral placebo once daily for 8 weeks. After 8 weeks of treatment, patients in arm I may receive Valeriana officinalis (Valerian) for an additional 8 weeks and patients in arm II may cross over to arm I. Pittsburgh Sleep Quality Index, functional outcomes of sleep, brief fatigue inventory, and profile of mood states questionnaires are completed at baseline and then at weeks 4, 8, 12, and 16. After completion of study treatment, patients are followed weekly for 2 weeks. PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study within approximately 11-22 months.

Official TitleThe 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
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

227 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersFatigueNervous System DiseasesNeurologic ManifestationsSleep Wake DisordersParasomnias

Criteria

DISEASE CHARACTERISTICS: * Diagnosis of cancer * Receiving adjuvant therapy, including any of the following: * Radiotherapy * Parenteral chemotherapy * Oral drugs * Hormonal therapy * Previously resected tumor, microscopic disease, or nodal or margin involvement allowed * Patients receiving intended curative treatment without future planned surgery (i.e., prostate cancer patients receiving radiotherapy followed by hormonal therapy) are eligible * Reports difficulty sleeping and seeking therapeutic intervention * Defined as a score over 3 on the numerical analogue scale * No obstructive sleep apnea * No prior diagnosis of primary insomnia per DSM IV criteria PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 6 months Hepatic * SGOT ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No chronic symptom that consistently interrupts sleep (e.g., hot flashes, unmanaged pain, or diarrhea) PRIOR CONCURRENT THERAPY: Other * No prior Valeriana officinalis (Valerian) for sleep * More than 1 month since other prior prescription sleeping-aid medication * No concurrent benzodiazepines except as short-term treatment for nausea

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Patients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks.

Group II

Placebo
Patients receive an oral placebo once daily for 8 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 33 locations

Suspended

Aurora Presbyterian Hospital

Aurora, United StatesSee the location
Suspended

Boulder Community Hospital

Boulder, United States
Suspended

Penrose Cancer Center at Penrose Hospital

Colorado Springs, United States
Suspended

Porter Adventist Hospital

Denver, United States
Completed33 Study Centers