Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00902330
First received: May 14, 2009
Last updated: March 19, 2015
Last verified: March 2015
Results First Received: May 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Anxiety Disorder
Breast Cancer
Depression
Fatigue
Pain
Sleep Disorders
Interventions: Procedure: energy-based therapy
Procedure: sham intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Women with stage I to IIIA breast cancer scheduled to receive chemotherapy with a performance score <2 recruited from five Cancer Centers across Virginia. Previous chemotherapy, dementia or active psychosis, seizure disorder, implanted electrical device, or taking medication psychiatric condition with 30 days prior to enrollment were excluded.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following completion of informed consent study participants were stratified by initial chemotherapy regimen (dose dense versus non-dose dense) and then randomly assigned to one of two groups: actual or sham CES.

Reporting Groups
  Description
Arm I (Cranial Microcurrent Electrical Stimulation [CES])

Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.

energy-based therapy: Given once a day for 18 weeks

Arm II (Sham CES)

Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.

sham intervention: Given once a day for 18 weeks


Participant Flow:   Overall Study
    Arm I (Cranial Microcurrent Electrical Stimulation [CES])     Arm II (Sham CES)  
STARTED     81     80  
COMPLETED     77     75  
NOT COMPLETED     4     5  
Too overwhelmed by treatment                 2                 5  
Adverse Event                 1                 0  
No post baseline data                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who completed trial

Reporting Groups
  Description
Arm I (Cranial Microcurrent Electrical Stimulation [CES])

Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.

energy-based therapy: Given once a day for 18 weeks

Arm II (Sham CES)

Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.

sham intervention: Given once a day for 18 weeks

Total Total of all reporting groups

Baseline Measures
    Arm I (Cranial Microcurrent Electrical Stimulation [CES])     Arm II (Sham CES)     Total  
Number of Participants  
[units: participants]
  77     75     152  
Age  
[units: years]
Median ± Standard Deviation
  51.03  ± 11.06     51.41  ± 8.55     51.22  ± 9.805  
Gender  
[units: participants]
     
Female     77     75     152  
Male     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     28     22     50  
White     46     49     95  
More than one race     0     0     0  
Unknown or Not Reported     3     4     7  
Region of Enrollment  
[units: participants]
     
United States     77     75     152  
Stage of Disease [1]
[units: participants]
     
Phase I     16     18     34  
Phase II     51     43     94  
Phase III     10     14     24  
[1] Staged with TNM classifications. The TNM system is based on the size and/or extent (reach) of the primary tumor (T), the amount of spread to nearby lymph nodes (N), and the presence of metastasis (M) or secondary tumors formed by the spread of cancer cells to other parts of the body.



  Outcome Measures
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1.  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   [ Time Frame: Up to 2 weeks afer completion of study treatment, for up to 8 months ]

2.  Secondary:   To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.   [ Time Frame: up to 2 weeks after completion of study treatment, for up to 8 months ]

3.  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).   [ Time Frame: Baseline ]

4.  Secondary:   Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).   [ Time Frame: Baseline ]

5.  Secondary:   Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline   [ Time Frame: Baseline ]

6.  Secondary:   Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy   [ Time Frame: Baseline ]

7.  Secondary:   Relationships Among Quality of Life Scores - Means at Baseline   [ Time Frame: Baseline ]

8.  Secondary:   Relationships Among Quality of Life Scores - Correlations at Baseline   [ Time Frame: Baseline ]

9.  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).   [ Time Frame: Midpoint Chemotherapy, up to 4 months ]

10.  Secondary:   Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy   [ Time Frame: Midpoint Chemotherapy, up to 4 months ]

11.  Secondary:   Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy   [ Time Frame: Midpoint Chemotherapy, up to 4 months ]

12.  Secondary:   Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy   [ Time Frame: Midpoint Chemotherapy, up to 4 months ]

13.  Secondary:   Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy   [ Time Frame: Midpoint Chemotherapy, up to 4 months ]

14.  Secondary:   Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy   [ Time Frame: Midpoint Chemotherapy, up to 4 months ]

15.  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).   [ Time Frame: Up to 2 weeks after completion of study treatment, for up to 8 months ]

16.  Secondary:   Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment   [ Time Frame: Up to 2 weeks afer completion of study treatment, for up to 8 months ]

17.  Secondary:   Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy   [ Time Frame: Up to 2 weeks afer completion of study treatment, for up to 8 months ]

18.  Secondary:   Relationships Among Symptom Scores - Correlations at End of Chemotherapy   [ Time Frame: Up to 2 weeks afer completion of study treatment, for up to 8 months ]

19.  Secondary:   Effects of Treatment on Quality of Life - Means at End of Treatment   [ Time Frame: up to 2 weeks after completion of study treatment, for up to 8 months ]

20.  Secondary:   Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy   [ Time Frame: Up to 2 weeks afer completion of study treatment, for up to 8 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Debra Lyon, RN, PhD, FNP
Organization: Virginia Commonwealth University
phone: 804-828-7743
e-mail: delyon@vcu.edu


No publications provided


Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00902330     History of Changes
Other Study ID Numbers: MCC-11995, HM11995, CDR0000641994, NCI-2011-00234
Study First Received: May 14, 2009
Results First Received: May 15, 2014
Last Updated: March 19, 2015
Health Authority: United States: Institutional Review Board