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

NCT00075842 | Completed Phase 3 DMC

• 3 other identifiers: NCCTG-N01C5NCI-2011-01604CDR0000349424
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 33

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.

Conditions

Fatigue; Sleep Disorders; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

sleep disorders; unspecified adult solid tumor, protocol specific; fatigue

Outcome Measures

Primary Outcomes (1)

• Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks

  at 6 weeks

Secondary Outcomes (1)

• Toxicity by questionnaires weekly and CTC grading every 2 weeks

  Up to 2 weeks post-treatment

Study Arms (2)

Arm I

EXPERIMENTAL

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

Dietary Supplement: Valeriana officinalis extract

Arm II

PLACEBO COMPARATOR

Patients receive an oral placebo once daily for 8 weeks.

Other: placebo

Interventions

Valeriana officinalis extract DIETARY_SUPPLEMENT

Given orally

Arm I

placebo OTHER

Given orally

Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (33)

Aurora Presbyterian Hospital

Aurora, Colorado, 80012, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301-9019, United States

Location

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, 80933, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Presbyterian - St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

St. Joseph Hospital

Denver, Colorado, 80218, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

CCOP - Colorado Cancer Research Program

Denver, Colorado, 80224-2522, United States

Location

Swedish Medical Center

Englewood, Colorado, 80110, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, 80502, United States

Location

St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, 81004, United States

Location

North Suburban Medical Center

Thornton, Colorado, 80229, United States

Location

Mercy Cancer Center at Mercy Medical Center - North Iowa

Mason City, Iowa, 50401, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

Meeker County Memorial Hospital

Lichfield, Minnesota, 55355, United States

Location

HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Minnesota Oncology Hematology, PA - Maplewood

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

HealthEast Cancer Care at St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

St. Francis Cancer Center at St. Francis Medical Center

Shakopee, Minnesota, 55379, United States

Location

HealthEast Cancer Care at Woodwinds Health Campus

Woodbury, Minnesota, 55125, United States

Location

Minnesota Oncology Hematology, PA - Woodbury

Woodbury, Minnesota, 55125, United States

Location

Related 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 undergoing treatment for cancer: a phase III randomized, placebo-controlled, double-blind study (NCCTG Trial, N01C5). J Support Oncol. 2011 Jan-Feb;9(1):24-31. doi: 10.1016/j.suponc.2010.12.008.

  PMID: 21399726 RESULT

MeSH Terms

Conditions

Fatigue; Sleep Wake Disorders

Interventions

Valeriana extract

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Study Officials

• Charles L. Loprinzi, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2004
• First Posted: January 13, 2004
• Study Start: August 1, 2003
• Primary Completion: March 1, 2007
• Study Completion: January 1, 2010
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

US (33)