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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

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

Treatments: Other: placebo; Dietary Supplement: Valeriana officinalis extract

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00075842

CDR0000349424 (Registry Identifier)

NCCTG-N01C5

NCI-2011-01604 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 227 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

227 participants in 2 patient groups, including a placebo group

Arm I

Experimental group

Description:

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

Treatment:

Dietary Supplement: Valeriana officinalis extract

Arm II

Placebo Comparator group

Description:

Patients receive an oral placebo once daily for 8 weeks.

Treatment:

Other: placebo