Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075842
Status:
COMPLETED
Last Update Posted:
2016-12-06
First Post:
2004-01-09
Brief Title:
Valerian for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-01604 | REGISTRY | None | None |
| CDR0000349424 | REGISTRY | PDQ Physician Data Query | None |