Healing Touch and Relaxation Therapies in Cervical Cancer Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

June 7, 2004

Last Updated Date

July 9, 2009

Start Date ^ICMJE

September 2002

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

natural killer cell cytotoxicity
side effects
CD4+ and CD8+IFNg+ lymphocytes
cortisol

Change History

Complete list of historical versions of study NCT00084123 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

WBC count
RBC
distress
neuropsychological measures
days of treatment delay

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Cervix Neoplasms

Intervention ^ICMJE

Behavioral: Healing Touch Therapy
Behavioral: Relaxation Therapy
Behavioral: Standard Care

Study Arms / Comparison Groups

Experimental: Healing Touch Therapy
Active Comparator: Relaxation Therapy
Placebo Comparator: Standard Care

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2007

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00084123

Responsible Party

Study ID Numbers ^ICMJE

P20 AT000756-01

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Susan K Lutgendorf, MD

University of Iowa

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

July 2009

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