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

Phase 3

Completed

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

• Registration Number: NCT00075842
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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.

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 Timeline

• Study Start: 2003-08
• Study First Submitted: 2004-01-09
• Study First Submitted QC: 2004-01-12
• Study First Posted: 2004-01-13
• Primary Completion: 2007-03
• Study Completion: 2010-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks	at 6 weeks

Secondary Outcome Measures

Name	Time	Method
Toxicity by questionnaires weekly and CTC grading every 2 weeks	Up to 2 weeks post-treatment

Trial Locations

Locations (33)

Aurora Presbyterian Hospital; 🇺🇸 Aurora, Colorado, United States

Boulder Community Hospital; 🇺🇸 Boulder, Colorado, United States

Penrose Cancer Center at Penrose Hospital; 🇺🇸 Colorado Springs, Colorado, United States

Porter Adventist Hospital; 🇺🇸 Denver, Colorado, United States

Presbyterian - St. Luke's Medical Center; 🇺🇸 Denver, Colorado, United States

St. Joseph Hospital; 🇺🇸 Denver, Colorado, United States

Rose Medical Center; 🇺🇸 Denver, Colorado, United States

CCOP - Colorado Cancer Research Program; 🇺🇸 Denver, Colorado, United States

Swedish Medical Center; 🇺🇸 Englewood, Colorado, United States

Sky Ridge Medical Center; 🇺🇸 Lone Tree, Colorado, United States

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