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Healing Touch and Immunity in Advanced Cervical Cancer Patients - Article


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Faith healing


Clinical Trial: Healing Touch and Immunity in Advanced Cervical Cancer Patients

This study is currently recruiting patients.

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

Purpose

The purpose of this study is to determine the effects of healing touch therapy on women with cancer who are undergoing chemotherapy and radiation.

Condition Treatment or Intervention Phase
Cervical Cancer
 Procedure: Healing Touch
 Procedure: Relaxation
Phase I
Phase II

MedlinePlus related topics:  Cervical Cancer

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: Exploratory Program Grant for Frontier Medicine

Further Study Details: 

Expected Total Enrollment:  64

Study start: August 2002;  Expected completion: April 2005

Healing touch (HT) is a therapy classified by NIH as a “biofield” therapy, as its effects are proposed to be the result of manipulation of hypothesized “energy fields” around the body of a patient. Although HT is frequently used as a complementary treatment by cancer patients undergoing chemotherapy and radiation to reduce toxic side effects of treatment and to maintain immunocompetence, effects of this treatment during cancer chemotherapy and radiation have not been investigated. Additionally, little is known about physiological mechanisms by which HT may work. A recent meta-analysis has demonstrated relatively large effects of HT on well-being and on physiological parameters, even from brief treatments. This study is designed to examine effects of HT on cellular immune function and short-term side effects of treatment among women with advanced cervical cancer who are receiving a standard 5-week course of external radiation therapy and concurrent chemotherapy. Although combined chemotherapy and radiation treatment is potentially curative in 69% of cases, many patients experience both acute and late side effects of radiation. Severe immune compromise has also been reported following intensive radiation. Identification of interventions that could reduce side effects and help maintain immunocompetence in advanced cervical cancer patients undergoing treatment is a critical health problem. There are no data on the effects of healing touch on immune function among cancer patients undergoing chemotherapy and radiation. Therefore this study is designed as an exploratory trial to determine whether such immune effects exist, and if so, what immune parameters are most likely to be affected. Effects of healing touch on mood and treatment-specific side-effects will also be examined. The significance of this study is that it will provide preliminary data on the impact, if any, of HT on various parameters of cellular immune function, beginning information on mechanisms of action, and whether the magnitude of the impact is large enough to be of sufficient clinical significance to be examined in larger clinical trials.

Eligibility

Ages Eligible for Study:  18 Years   -   90 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Use of immunomodulating medications (eg. steroids)
  • Distant metastases

Location and Contact Information


Iowa
      University of Iowa, Iowa City,  Iowa,  52242,  United States; Recruiting
Heena Maiseri, B.S.  319-335-0145    heena-maiseri@uiowa.edu 
Susan Lutgendorf, Ph.D.  319-335-2432 
Susan K. Lutgendorf, Ph.D.,  Principal Investigator

More Information

Study ID Numbers:  1 P20 AT00756-01P4
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  July 17, 2003
ClinicalTrials.gov Identifier:  NCT00065091
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: September 6, 2005
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