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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075842
• Other study ID #: NCCTG-N01C5
• Secondary ID: NCI-2011-01604CD
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2004
• Last updated: December 2, 2016
• Start date: August 2003
• Est. completion date: January 2010

Study information

• Verified date: December 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: January 2010
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Valeriana officinalis extract
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	Aurora Presbyterian Hospital	Aurora	Colorado
United States	Boulder Community Hospital	Boulder	Colorado
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	CCOP - Colorado Cancer Research Program	Denver	Colorado
United States	Porter Adventist Hospital	Denver	Colorado
United States	Presbyterian - St. Luke's Medical Center	Denver	Colorado
United States	Rose Medical Center	Denver	Colorado
United States	St. Joseph Hospital	Denver	Colorado
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Swedish Medical Center	Englewood	Colorado
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	Meeker County Memorial Hospital	Lichfield	Minnesota
United States	Sky Ridge Medical Center	Lone Tree	Colorado
United States	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado
United States	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota
United States	Minnesota Oncology Hematology, PA - Maplewood	Maplewood	Minnesota
United States	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota
United States	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	St. Francis Cancer Center at St. Francis Medical Center	Shakopee	Minnesota
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	HealthEast Cancer Care at St. Joseph's Hospital	St Paul	Minnesota
United States	United Hospital	St. Paul	Minnesota
United States	North Suburban Medical Center	Thornton	Colorado
United States	CCOP - Wichita	Wichita	Kansas
United States	HealthEast Cancer Care at Woodwinds Health Campus	Woodbury	Minnesota
United States	Minnesota Oncology Hematology, PA - Woodbury	Woodbury	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Barton DL, Atherton PJ, Bauer BA, Moore DF Jr, Mattar BI, Lavasseur BI, Rowland KM Jr, Zon RT, Lelindqwister NA, Nagargoje GG, Morgenthaler TI, Sloan JA, Loprinzi CL. The use of Valeriana officinalis (Valerian) in improving sleep in patients who are under — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks		at 6 weeks	No
Secondary	Toxicity by questionnaires weekly and CTC grading every 2 weeks		Up to 2 weeks post-treatment	Yes