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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fatigue Sleep Disorders Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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sleep disorders unspecified adult solid tumor, protocol specific fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I

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

Group Type EXPERIMENTAL

Valeriana officinalis extract

Intervention Type DIETARY_SUPPLEMENT

Given orally

Arm II

Patients receive an oral placebo once daily for 8 weeks.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given orally

Interventions

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Valeriana officinalis extract

Given orally

Intervention Type DIETARY_SUPPLEMENT

placebo

Given orally

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles L. Loprinzi, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status