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Healing Touch and Immunity in Advanced Cervical Cancer Patients
This study has been completed.
First Received: July 17, 2003   Last Updated: September 28, 2007   History of Changes
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00065091
  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 Intervention Phase
Cervical Cancer
Procedure: Healing Touch
Procedure: Relaxation
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Exploratory Program Grant for Frontier Medicine

Resource links provided by NLM:


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

Estimated Enrollment: 64
Study Start Date: August 2002
Study Completion Date: April 2007
Detailed Description:

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 to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with squamous or adenocarcinoma of stages Ib1 through IVa

Exclusion Criteria:

  • Use of immunomodulating medications (eg. steroids)
  • Distant metastases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065091

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Investigators
Principal Investigator: Susan Lutgendorf, PhD University of Iowa
  More Information

No publications provided

Study ID Numbers: P20 AT000756-01P4
Study First Received: July 17, 2003
Last Updated: September 28, 2007
ClinicalTrials.gov Identifier: NCT00065091     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Cancer
Cervical Cancer
Healing Touch
Therapeutic Touch
Immunotherapy

ClinicalTrials.gov processed this record on July 02, 2009