Healing Touch and Relaxation Therapies in Cervical Cancer Patients

Cervix Neoplasms Clinical Trial

Official title:

Healing Touch in Advanced Cervical Cancer Patients: Immune Effects and Mechanisms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00084123
• Other study ID #: P20AT000756-01
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2004
• Last updated: July 9, 2009
• Start date: September 2002
• Est. completion date: April 2007

Study information

• Verified date: July 2009
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00065091

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervix Neoplasms
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Healing Touch Therapy

• Relaxation Therapy

• Standard Care
Standard Care

Locations

Country	Name	City	State
United States	University of Iowa Hospital and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	natural killer cell cytotoxicity		Baseline to week 6	No
Primary	T-cell counts		Baseline to week 6	No
Primary	side effects		Baseline to week 6	No
Secondary	distress		Baseline to week 6	No
Secondary	WBC and RBC		Baseline to week 6	No
Secondary	days of treatment delay		Baseline to week 6	No
Secondary	salivary cortisol		Baseline to post-treatment	No