Clinical trial · Interventional
(Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Sleep Disorders | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| Valeriana officinalis extract | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks.
- interventionNames
- Dietary Supplement: Valeriana officinalis extract
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive an oral placebo once daily for 8 weeks.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks
- timeFrame
- at 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTBarton 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