Healing Touch, Quality of Life, and Immunity During Breast Cancer Treatment

NCT00565305 | Completed DMC

• 1 other identifier: 200305053
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to understand effects of a complementary medicine therapy, Healing Touch on quality of life and immunity of patients who are receiving treatment for breast cancer. Healing Touch is a Holistic Therapy used as an adjunct to medical treatment. The goal of Healing Touch is to restore energy and vitality to the body as a patient is receiving treatment for cancer. Treatments include light touch on specific points on the body as well as around the body, to increase well-being and support the body's ability to heal. Healing Touch has been shown to increase relaxation and well-being and to decrease anxiety, pain, and treatment side effects in a variety of illnesses including cancer. Although Healing Touch is frequently used by cancer patients along with their medical treatments, very little is understood about the effects of this treatment on the immune system. The immune system is known to be important in the body's response to fighting cancer. We are studying Healing Touch to help us understand whether or not these treatments are effective in supporting the immune system during breast cancer treatment Aim 1. To evaluate effects of a healing touch (HT) intervention on cellular immunity among early stage breast cancer patients during radiotherapy. Aim 2. To evaluate effects of a Healing Touch (HT) intervention on cytokines associated with radiation damage and acute skin reactions in early stage breast cancer patients during radiotherapy. Aim 3. To evaluate the effects of a Healing Touch intervention on fatigue and mood in early stage breast cancer patients during radiation treatment.

Conditions

Breast Cancer

Keywords

Healing Touch; NK cytotoxicity; cytokines; fatigue

Outcome Measures

Primary Outcomes (1)

• NK cell activity; sTNFRII; IL-1ra; fatigue (FSI); depression (CES-D); acute skin reactions

  six weeks

Secondary Outcomes (1)

• WBC, distress (POMS), sleep quality, days of interrupted treatment

  six weeks

Study Arms (2)

Healing Touch

EXPERIMENTAL

Healing Touch + Standard Treatment Healing Touch treatments daily following standard Radiation Therapy. Standard radiation therapy is part of their medical care and is not administered as part of this study. Protocol of 4 HT techniques will be used including Pain Drain, Chakra connection, Magnetic Unruffling, and Mind Clearing. Treatments will be approximately 20-30 minutes.

Behavioral: Healing Touch; Radiation: Standard Treatment

Usual Care

ACTIVE COMPARATOR

Standard Treatment. These patients receive usual medical care but no additional intervention. Standard treatment is not administered as part of this study but as part of their medical treatment.

Radiation: Standard Treatment

Interventions

Healing Touch BEHAVIORAL

Healing Touch (HT) is a non-invasive therapeutic approach to healing which describes its mode of action as using touch to modulate the patient's energy system. The goal of HT is to restore harmony and balance in the patient's energy system to assist the person to self-heal.88 Healing Touch, as used here, refers to the techniques taught in Mentgen's standardized curriculum of Healing Touch offered through Healing Touch International and endorsed by the American Holistic Nurse's Association

Healing Touch

Standard Treatment RADIATION

4-6 cycles of cytotoxic chemotherapy followed by 5040 cGy of external beam whole breast radiotherapy in 28 fractions usually followed by a boost of 1000-1600 cGy

Healing Touch; Usual Care

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer patients who have received either a mastectomy or breast conservative surgery
• Diagnosis of Stage I-IIIa breast cancer,
• Receiving either chemotherapy + radiation or radiation alone

You may not qualify if:

• Past history of cancer
• Recurrent cancer
• Greater than Stage IIIa breast cancer
• History of immunosuppressive disorders (e.g. HIV, AIDS, hepatitis, etc.)
• On immunosuppressive medications
• On corticosteroids (e.g. Prednisone)

Sponsors & Collaborators

• University of Iowa: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Holden Comprehensive Cancer Center, University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (25)

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  BACKGROUND

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  BACKGROUND

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  RESULT

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  RESULT

• Wirth D, Richardson J, Eidelman W, O'Malley A. Full thickness dermal wounds treated with non-contact therapeutic touch: A replication and extension. Complemenatary Therapies in Medicine 1:127-132, 1993.

  RESULT

• Wirth D, Barret M, Eidelman W. Non-contact therapeutic touch and wound re-epithelialization: An extension of previous research. Complementary Therapies in Medicine 2:187-192, 1994.

  RESULT

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MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Interventions

Touch

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Susan K Lutgendorf, PhD

  Department of Psychology, University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2007
• First Posted: November 29, 2007
• Study Start: July 1, 2003
• Primary Completion: June 1, 2008
• Study Completion: November 1, 2009
• Last Updated: March 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)