Healing Touch and Relaxation Therapies in Cervical Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00084123
First received: June 7, 2004
Last updated: July 9, 2009
Last verified: July 2009

June 7, 2004
July 9, 2009
September 2002
April 2007   (final data collection date for primary outcome measure)
  • natural killer cell cytotoxicity [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • T-cell counts [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • side effects [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00084123 on ClinicalTrials.gov Archive Site
  • distress [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • WBC and RBC [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • days of treatment delay [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • salivary cortisol [ Time Frame: Baseline to post-treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Healing Touch and Relaxation Therapies in Cervical Cancer Patients
Healing Touch in Advanced Cervical Cancer Patients: Immune Effects and Mechanisms

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervix Neoplasms
  • Behavioral: Healing Touch Therapy
  • Behavioral: Relaxation Therapy
  • Behavioral: Standard Care
    Standard Care
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2007
April 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00084123
P20 AT000756-01
Yes
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Susan K Lutgendorf, MD University of Iowa
National Center for Complementary and Alternative Medicine (NCCAM)
July 2009

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