Healing Touch and Relaxation Therapies in Cervical Cancer Patients - Full Text View

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00084123

Purpose

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	Intervention	Phase
Cervix Neoplasms	Behavioral: Healing Touch Therapy Behavioral: Relaxation Therapy Behavioral: Standard Care	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Healing Touch in Advanced Cervical Cancer Patients: Immune Effects and Mechanisms

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	60
Study Start Date:	September 2002
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Healing Touch: Experimental Healing Touch Therapy	Behavioral: Healing Touch Therapy
Relaxation Therapy: Active Comparator Relaxation Therapy	Behavioral: Relaxation Therapy
Standard Care: Placebo Comparator Standard Care	Behavioral: Standard Care Standard Care

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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 Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Susan K Lutgendorf, MD

University of Iowa

More Information

No publications provided

Study ID Numbers:	P20 AT000756-01
Study First Received:	June 7, 2004
Last Updated:	July 9, 2009
ClinicalTrials.gov Identifier:	NCT00084123 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Relaxation Techniques
Radiation
Drug Therapy
Healing Touch

Additional relevant MeSH terms:

Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Neoplasms
Neoplasms by Site

Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009