search
Back to results

Healing Touch and Relaxation Therapies in Cervical Cancer Patients

Primary Purpose

Cervix Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Healing Touch Therapy
Relaxation Therapy
Standard Care
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervix Neoplasms focused on measuring Relaxation Techniques, Radiation, Drug Therapy, Healing Touch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Iowa Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Healing Touch

Relaxation Therapy

Standard Care

Arm Description

Healing Touch Therapy

Relaxation Therapy

Standard Care

Outcomes

Primary Outcome Measures

natural killer cell cytotoxicity
T-cell counts
side effects

Secondary Outcome Measures

distress
WBC and RBC
days of treatment delay
salivary cortisol

Full Information

First Posted
June 7, 2004
Last Updated
July 9, 2009
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00084123
Brief Title
Healing Touch and Relaxation Therapies in Cervical Cancer Patients
Official Title
Healing Touch in Advanced Cervical Cancer Patients: Immune Effects and Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Neoplasms
Keywords
Relaxation Techniques, Radiation, Drug Therapy, Healing Touch

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healing Touch
Arm Type
Experimental
Arm Description
Healing Touch Therapy
Arm Title
Relaxation Therapy
Arm Type
Active Comparator
Arm Description
Relaxation Therapy
Arm Title
Standard Care
Arm Type
Placebo Comparator
Arm Description
Standard Care
Intervention Type
Behavioral
Intervention Name(s)
Healing Touch Therapy
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Therapy
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Standard Care
Primary Outcome Measure Information:
Title
natural killer cell cytotoxicity
Time Frame
Baseline to week 6
Title
T-cell counts
Time Frame
Baseline to week 6
Title
side effects
Time Frame
Baseline to week 6
Secondary Outcome Measure Information:
Title
distress
Time Frame
Baseline to week 6
Title
WBC and RBC
Time Frame
Baseline to week 6
Title
days of treatment delay
Time Frame
Baseline to week 6
Title
salivary cortisol
Time Frame
Baseline to post-treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan K Lutgendorf, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Healing Touch and Relaxation Therapies in Cervical Cancer Patients

We'll reach out to this number within 24 hrs