FatiguePhase 3NCT00075842
(Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy
A Phase 3 study testing Valeriana officinalis extract in people with Fatigue and Sleep Disorders, run by Alliance for Clinical Trials in Oncology at 33 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, Sleep Disorders, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Valeriana officinalis extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 33 sitesUnited States
- Study dates
- Aug 2003to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Aurora Presbyterian Hospital
Aurora, Colorado, 80012
Boulder Community Hospital
Boulder, Colorado, 80301-9019
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433
Porter Adventist Hospital
Denver, Colorado, 80210
Presbyterian - St. Luke's Medical Center
Denver, Colorado, 80218
St. Joseph Hospital
Denver, Colorado, 80218
Rose Medical Center
Denver, Colorado, 80220
CCOP - Colorado Cancer Research Program
Denver, Colorado, 80224-2522
Fairview Southdale Hospital
Edina, Minnesota, 55435
Swedish Medical Center
Englewood, Colorado, 80110
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350
Meeker County Memorial Hospital
Lichfield, Minnesota, 55355
Sky Ridge Medical Center
Lone Tree, Colorado, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, 80502
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, 55109
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, 50401
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, 81004
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul, Minnesota, 55102
United Hospital
Saint Paul, Minnesota, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104
North Suburban Medical Center
Thornton, Colorado, 80229
CCOP - Wichita
Wichita, Kansas, 67214
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, 55125
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, 55125
About this study
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
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.
Read the 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.
- Being tested
- Valeriana officinalis extract, placebo
- Keywords
- sleep disorders, unspecified adult solid tumor, protocol specific, fatigue
- Medical subject headings
- Fatigue, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valeriana officinalis extractDietary supplement
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks. Receives: Dietary Supplement: Valeriana officinalis extract |
| Arm II | Placebo comparator | Patients receive an oral placebo once daily for 8 weeks. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks
Measured: at 6 weeks
Secondary outcomes (1)
Toxicity by questionnaires weekly and CTC grading every 2 weeks
Measured: Up to 2 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2004 (estimated)
- Study startAug 2003
- Primary completionMar 2007
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles L. Loprinzi, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075842
- Sponsor's protocol ID
- NCCTG-N01C5
- Other IDs
- NCI-2011-01604, CDR0000349424
- Status last verified
- Dec 2016
- First submitted
- 9 Jan 2004
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21399726
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00075842
- Acronym / sponsor ID
- NCCTG-N01C5
- Keywords
- sleep disorders, unspecified adult solid tumor, protocol specific, fatigue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2003
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Dietary Supplement: Valeriana officinalis extractPatients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks. |
| Arm II | Placebo comparator | Other: placeboPatients receive an oral placebo once daily for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valeriana officinalis extractGiven orally | Dietary supplement | Arm I |
| placeboGiven orally | Other | Arm II |
Primary outcome
Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks
Time frame: at 6 weeks
1 secondary outcome
Toxicity by questionnaires weekly and CTC grading every 2 weeks
Time frame: Up to 2 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Results publication: PubMed 21399726Barton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles L. Loprinzi, MD study chair
Mayo Clinic
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valeriana officinalis extract in people with Fatigue and Sleep Disorders, run by Alliance for Clinical Trials in Oncology at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks (time frame: at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00075842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.