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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00075842

Collaborator

National Cancer Institute (NCI) (NIH)

227

Enrollment

Locations

Arms

Duration (Months)

6.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fatigue Sleep Disorders Unspecified Adult Solid Tumor, Protocol Specific	Dietary Supplement: Valeriana officinalis extract Other: placebo	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

227 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

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

Study Start Date :

Aug 1, 2003

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks.	Dietary Supplement: Valeriana officinalis extract Given orally
Placebo Comparator: Arm II Patients receive an oral placebo once daily for 8 weeks.	Other: placebo Given orally

Arm

Intervention/Treatment

Experimental: Arm I

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

Dietary Supplement: Valeriana officinalis extract

Given orally

Placebo Comparator: Arm II

Patients receive an oral placebo once daily for 8 weeks.

Other: placebo

Given orally

Outcome Measures

Primary Outcome Measures

Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks [at 6 weeks]

Secondary Outcome Measures

Toxicity by questionnaires weekly and CTC grading every 2 weeks [Up to 2 weeks post-treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aurora Presbyterian Hospital	Aurora	Colorado	United States	80012
2	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
3	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado	United States	80933
4	Porter Adventist Hospital	Denver	Colorado	United States	80210
5	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
6	St. Joseph Hospital	Denver	Colorado	United States	80218
7	Rose Medical Center	Denver	Colorado	United States	80220
8	CCOP - Colorado Cancer Research Program	Denver	Colorado	United States	80224-2522
9	Swedish Medical Center	Englewood	Colorado	United States	80110
10	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
11	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado	United States	80502
12	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
13	North Suburban Medical Center	Thornton	Colorado	United States	80229
14	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa	United States	50401
15	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
16	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
17	CCOP - Wichita	Wichita	Kansas	United States	67214
18	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
19	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota	United States	55433
20	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
21	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota	United States	55432
22	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
23	Meeker County Memorial Hospital	Lichfield	Minnesota	United States	55355
24	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota	United States	55109
25	Minnesota Oncology Hematology, PA - Maplewood	Maplewood	Minnesota	United States	55109
26	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota	United States	55407
27	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
28	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
29	St. Francis Cancer Center at St. Francis Medical Center	Shakopee	Minnesota	United States	55379
30	HealthEast Cancer Care at St. Joseph's Hospital	St Paul	Minnesota	United States	55102
31	United Hospital	St. Paul	Minnesota	United States	55102
32	HealthEast Cancer Care at Woodwinds Health Campus	Woodbury	Minnesota	United States	55125
33	Minnesota Oncology Hematology, PA - Woodbury	Woodbury	Minnesota	United States	55125