Healing Touch and Relaxation Therapies in Cervical Cancer Patients

Sponsor

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Overall Status

Completed

CT.gov ID

NCT00084123

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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

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 :

Sep 1, 2002

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Apr 1, 2007

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

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

natural killer cell cytotoxicity [Baseline to week 6]
T-cell counts [Baseline to week 6]
side effects [Baseline to week 6]

Secondary Outcome Measures

distress [Baseline to week 6]
WBC and RBC [Baseline to week 6]
days of treatment delay [Baseline to week 6]
salivary cortisol [Baseline to post-treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00084123

Other Study ID Numbers:

P20AT000756-01
NCT00065091

First Posted:

Jun 8, 2004

Last Update Posted:

Jul 10, 2009

Last Verified:

Jul 1, 2009

Keywords provided by , ,

Relaxation Techniques

Radiation

Drug Therapy

Healing Touch

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Jul 10, 2009