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Phase 3 N=161 Randomized Triple-blind Supportive Care

Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

Anxiety Disorder · Breast Cancer · Depression · Fatigue · Pain

Bottom Line

View on ClinicalTrials.gov: NCT00902330 ↗
Enrolled (actual)
161
Serious AEs
0.7%
Results posted
Apr 2015
Primary outcome: Primary: Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer — 4.040; 4.529; 4.520; 4.565 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
energy-based therapy (Procedure); sham intervention (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Virginia Commonwealth University
Primary completion
May 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer		 4.040; 4.529; 4.520; 4.565; 3.349; 3.191 —
SECONDARY
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.		 20; 85; 89; 9; 88; 22 —
SECONDARY
Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).		 28.64; 28.92; 9.88; 32.60; 0.33; 0.09 <0.05 sig
SECONDARY
Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).		 0.031; 0.243; 0.002; 0.453; 0.570; 0.320 —
SECONDARY
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline		 7.09; 7.59; 3.03; 3.06; 1.95; 2.63 —
SECONDARY
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy		 0.610; 0.303; 0.298; 0.474; 0.343; 0.315 —
SECONDARY
Relationships Among Quality of Life Scores - Means at Baseline		 113.44; 111.83; 27.42; 26.05 —
SECONDARY
Relationships Among Quality of Life Scores - Correlations at Baseline		 0.744 —
SECONDARY
Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).		 28.64; 29.00; 10.50; 1.35; 0.68; 0.73 —
SECONDARY
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy		 0.060; 0.337; 0.102; 0.390; 0.593; 0.298 —
SECONDARY
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy		 4.40; 4.98; 4.24; 4.02; 3.15; 3.14 —
SECONDARY
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy		 0.723; 0.512; 0.305; 0.604; 0.632; 0.412 —
SECONDARY
Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy		 111.57; 108.45; 26.96; 25.96 —
SECONDARY
Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy		 0.743 —
SECONDARY
Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).		 28.64; 29.00; 10.50; 1.35; 0.68; 0.73 —
SECONDARY
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment		 0.057; 0.343; 0.135; 0.383; 0.464; 0.134 —
SECONDARY
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy		 4.07; 4.51; 4.47; 4.63; 3.34; 3.32 —
SECONDARY
Relationships Among Symptom Scores - Correlations at End of Chemotherapy		 0.678; 0.467; 0.409; 0.515; 0.564; 0.368 —
SECONDARY
Effects of Treatment on Quality of Life - Means at End of Treatment		 108.11; 105.96; 25.51; 24.66 —
SECONDARY
Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy		 0.772 —

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of stage I-IIIA breast cancer
  • Scheduled to receive adjuvant chemotherapy
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Pre, peri, or post-menopausal
  • ECOG performance status 0-1
  • No dementia
  • No active psychosis
  • No history of seizure disorder
  • No implanted electrical device

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy
  • No initiation of a medication regimen for depression or other psychiatric condition within the past 30 days
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00902330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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