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Healing Touch and Relaxation Therapies in Cervical Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00084123
Recruitment Status : Completed
First Posted : June 8, 2004
Last Update Posted : July 10, 2009
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Tracking Information
First Submitted Date  ICMJE June 7, 2004
First Posted Date  ICMJE June 8, 2004
Last Update Posted Date July 10, 2009
Study Start Date  ICMJE September 2002
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2009)
  • natural killer cell cytotoxicity [ Time Frame: Baseline to week 6 ]
  • T-cell counts [ Time Frame: Baseline to week 6 ]
  • side effects [ Time Frame: Baseline to week 6 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2009)
  • distress [ Time Frame: Baseline to week 6 ]
  • WBC and RBC [ Time Frame: Baseline to week 6 ]
  • days of treatment delay [ Time Frame: Baseline to week 6 ]
  • salivary cortisol [ Time Frame: Baseline to post-treatment ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healing Touch and Relaxation Therapies in Cervical Cancer Patients
Official Title  ICMJE Healing Touch in Advanced Cervical Cancer Patients: Immune Effects and Mechanisms
Brief Summary The purpose of this study is to evaluate the effects of healing touch and relaxation therapy on cervical cancer patients undergoing chemotherapy and radiation treatment.
Detailed Description

The side effects of chemotherapy and radiation treatment are often severe and can have devastating effects on the mental and physical well-being of cancer patients. This study will determine whether healing touch and relaxation therapy are effective in minimizing the side effects of chemotherapy and radiation treatment in cervical cancer patients.

Participants in this study will receive weekly chemotherapy and daily radiation treatments for 6 weeks. Participants will be randomly assigned to receive either standard care (SC), SC plus relaxation therapy, or SC plus healing touch therapy. The relaxation therapy consists of progressive muscle relaxation and guided imagery. The healing touch therapy involves an energy-based modality in which health care practitioners stimulate the energy fields surrounding the patient. A physician-completed assessment and measures of immune function will be used to assess the well-being and overall quality of life of participants.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervix Neoplasms
Intervention  ICMJE
  • Behavioral: Healing Touch Therapy
  • Behavioral: Relaxation Therapy
  • Behavioral: Standard Care
    Standard Care
Study Arms  ICMJE
  • Experimental: Healing Touch
    Healing Touch Therapy
    Intervention: Behavioral: Healing Touch Therapy
  • Active Comparator: Relaxation Therapy
    Relaxation Therapy
    Intervention: Behavioral: Relaxation Therapy
  • Placebo Comparator: Standard Care
    Standard Care
    Intervention: Behavioral: Standard Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2009)		 60
Original Enrollment  ICMJE
 (submitted: June 23, 2005)		 90
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Stage Ib1-IVa cervical cancer
  • Treatment with concurrent chemotherapy and radiation at the University of Iowa Hospitals and Clinics

Exclusion Criteria:

  • Immunosuppressive disorders
  • Use of immunosuppressive medications
  • Transplant recipient
  • Metastatic or recurrent cervical cancer
  • History of any other type of cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00084123
Other Study ID Numbers  ICMJE P20AT000756-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan K Lutgendorf, MD University of Iowa
PRS Account National Center for Complementary and Integrative Health (NCCIH)
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP