CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 161 enrolled
Drug / intervention
energy-based therapy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00902330
NCT00902330Phase 3Completed
CompareCT.gov

Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

Virginia Commonwealth University·interventional·Posted May 15, 2009·Updated Nov 23, 2015

In Brief

A Phase 3 clinical trial evaluating energy-based therapy and sham intervention for Anxiety Disorder and 5 related conditions. Completed, enrolled 161 participants.

Detailed Summary

RATIONALE: Cranial microcurrent electrical stimulation (CES) is mild electrical current received through electrodes placed on the earlobes. CES may lessen symptoms in women with breast cancer receiving chemotherapy. It is not yet known whether CES is more effective than sham therapy in reducing symptoms caused by chemotherapy in women with breast cancer. PURPOSE: This randomized phase III trial is studying mild electrical stimulation to see how well it works compared with sham therapy in reducing symptoms caused by chemotherapy in women with stage I, stage II, or stage IIIA breast cancer receiving chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnxiety Disorder, Breast Cancer, Depression, Fatigue, Pain, Sleep Disorders
Countries--
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2009
Enrollment StartApr 1, 2009
Primary CompletionMay 1, 2013
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 17.1 years ago

Interventions

energy-based therapyprocedure

Given once a day for 18 weeks

sham interventionprocedure

Given once a day for 18 weeks