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Completed

NCT Number: NCT04905576

Quality of Life Interventions During Cervical Cancer Treatment

The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.

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Key information

About this study

Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side effects, and immunosuppression. This prospective randomized clinical trial proposes to examine the effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with stage I-IVa cervical cancer pursuing concurrent chemotherapy and radiation therapy.

Exclusion criteria

  • Greater than Stage IVa cervical cancer
  • Metastatic or recurrent cervical cancer
  • Patients receiving only chemotherapy or only radiation therapy
  • History of cancer of any site
  • History of a transplant
  • Diagnosed with any immunosupressive disorder (HIV, AIDS).

Treatment and study plan

Relaxation Training

Behavioral

Muscle relaxation training

Other names: Relaxation

Therapeutic Touch

Behavioral

Healing Touch (HT) therapy

Other names: Healing touch

Questionnaire Administration

Other

Ancillary studies

Other

Subjects in all groups will give 4 blood samples during the study

Other names: Blood draw

Primary outcomes

  1. Change in natural killer cell cytotoxicity (NKCC)

    Time frame: 6 weeks

    Compare change in natural killer cell cytotoxicity of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.

    Fresh peripheral blood mononuclear cells tested for cytolytic activity against the NK-sensitive K562 cells and the NK-resistant LAK-sensitive ZKBL cells in a standard 4-h 51Chromium- release assay.

  2. Number of chemoradiation-related toxicities

    Time frame: 6 weeks

    Compare number of reported side effects of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care as measured by the Common Toxicity Criteria Manual Version 2.0

  3. Number of days of treatment delay due to chemoradiation-related toxicities

    Time frame: 6 weeks

    Compare number of days in treatment delay due to chemoradiation-related toxicity for participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care

  4. Change in participant reports of depression

    Time frame: 6 weeks

    Compare changes in depression scores of participants receiving HT to participants receiving relaxation training or usual care during radiation and chemotherapy as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) in which higher scores indicate worse depression (range 0-60)

Secondary outcomes

  1. Change in participant reports of anxiety

    Time frame: 6 weeks

    Compare changes in reported anxiety of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Profile of Mood States- Anxiety Subscale (POMS-SF) (range 0-28)

  2. Change in white blood cell counts

    Time frame: 6 weeks

    Compare change in white blood cell counts of participants receiving HT during radiation and chemotherapy vs. patients receiving relaxation training or usual care during this time

    hemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.

  3. Change in red blood cell counts

    Time frame: 6 weeks

    Compare change in red blood cell counts of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.

  4. Change in participant reports of quality of life

    Time frame: 6 weeks

    Compare change in reported quality of life of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Functional assessment of Cancer therapies (FACT). Higher scores indicate better quality of life. Range= (0-136).

  5. Change in participant reports of fatigue

    Time frame: 6 weeks

    Compare reported fatigue of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Fatigue Severity Inventory (FSI). Mean fatigue intensity (range 0-10) with higher scores indicating more fatigue, and fatigue duration in days last week experiencing fatigue (0-7 days) with greater number of days indicating greater fatigue duration.

  6. Change in metabolomic measures

    Time frame: 6 weeks

    Compare metabolic profile of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care. Samples were assayed using Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectroscopy (UPLC-MS/MS). The metabolomic profiling analysis measures the quantity of specific compounds in the plasma vs. a platform of 844 known metabolites in a commercial platform powered by Metabolon, Inc. For any specific metabolite, higher levels indicates greater presence of the metabolite.

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Important dates

Study start
2001
Primary completion
2008
Study completion
2014
First posted
May 27, 2021
Registry last updated
May 27, 2021

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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