Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Not Enrolling
Both
Fatigue, Sleep Disorders, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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


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.

Inclusion 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

Hematopoietic

- Not specified

Hepatic

- SGOT ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 1.5 times ULN

Renal

- Not specified

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:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- See Disease Characteristics

Radiotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks

Safety Issue:

No

Principal Investigator

Charles L. Loprinzi, MD

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000349424

NCT ID:

NCT00075842

Start Date:

August 2003

Completion Date:

Related Keywords:

  • Fatigue
  • Sleep Disorders
  • Unspecified Adult Solid Tumor, Protocol Specific
  • sleep disorders
  • unspecified adult solid tumor, protocol specific
  • fatigue
  • Fatigue
  • Sleep Disorders
  • Parasomnias

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
CCOP - Colorado Cancer Research ProgramDenver, Colorado  80224-2522
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
St. Mary - Corwin Regional Medical CenterPueblo, Colorado  81004
North Suburban Medical CenterThornton, Colorado  80229
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's HospitalSt Paul, Minnesota  55102
United HospitalSt. Paul, Minnesota  55102
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health CampusWoodbury, Minnesota  55125
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401