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 Supplement
Other
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-Controlled
Phase 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, 2003Actual 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Mental Disorders
Fatigue
Nervous System Diseases
Neurologic Manifestations
Sleep Wake Disorders
Parasomnias
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.

Given orally
Group II
Placebo
Patients receive an oral placebo once daily for 8 weeks.

Given orally
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 HospitalAurora, United StatesSee the location
Suspended
Boulder Community HospitalBoulder, United States
Suspended
Penrose Cancer Center at Penrose HospitalColorado Springs, United States
Suspended
Porter Adventist HospitalDenver, United States
Completed33 Study Centers
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