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Completed

NCT Number: NCT00084123

Healing Touch and Relaxation Therapies in Cervical Cancer Patients

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.

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Key information

Conditions

Cervix Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healing Touch Therapy

Behavioral

Relaxation therapy

Behavioral

Standard Care

Behavioral

Standard Care

Primary outcomes

  1. natural killer cell cytotoxicity

    Time frame: Baseline to week 6

  2. T-cell counts

    Time frame: Baseline to week 6

  3. side effects

    Time frame: Baseline to week 6

Secondary outcomes

  1. distress

    Time frame: Baseline to week 6

  2. WBC and RBC

    Time frame: Baseline to week 6

  3. days of treatment delay

    Time frame: Baseline to week 6

  4. salivary cortisol

    Time frame: Baseline to post-treatment

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Jun 8, 2004
Registry last updated
Jul 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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