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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:

Study Description
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.

Condition or disease Intervention/treatment Phase
Cervix Neoplasms Behavioral: Healing Touch Therapy Behavioral: Relaxation Therapy Behavioral: Standard Care Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Healing Touch in Advanced Cervical Cancer Patients: Immune Effects and Mechanisms
Study Start Date : September 2002
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Healing Touch
Healing Touch Therapy
Behavioral: Healing Touch Therapy
Active Comparator: Relaxation Therapy
Relaxation Therapy
Behavioral: Relaxation Therapy
Placebo Comparator: Standard Care
Standard Care
Behavioral: Standard Care
Standard Care


Outcome Measures

Primary Outcome Measures :
  1. natural killer cell cytotoxicity [ Time Frame: Baseline to week 6 ]
  2. T-cell counts [ Time Frame: Baseline to week 6 ]
  3. side effects [ Time Frame: Baseline to week 6 ]

Secondary Outcome Measures :
  1. distress [ Time Frame: Baseline to week 6 ]
  2. WBC and RBC [ Time Frame: Baseline to week 6 ]
  3. days of treatment delay [ Time Frame: Baseline to week 6 ]
  4. salivary cortisol [ Time Frame: Baseline to post-treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084123


Locations
United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Susan K Lutgendorf, MD University of Iowa
More Information

ClinicalTrials.gov Identifier: NCT00084123     History of Changes
Obsolete Identifiers: NCT00065091
Other Study ID Numbers: P20AT000756-01 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2004    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: July 2009

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Relaxation Techniques
Radiation
Drug Therapy
Healing Touch

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female