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Cervical CancerNCT04905576

Quality of Life Interventions During Cervical Cancer Treatment

A study testing Relaxation training, Therapeutic touch and Questionnaire administration in people with Cervical Cancer, run by University of Iowa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 100 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Relaxation training, Therapeutic touch and Questionnaire administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
4 Jun 2001to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).

About this study

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

Read the detailed description

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.

Conditions
Cervical Cancer
Being tested
Relaxation training, Therapeutic touch, Questionnaire administration, Ancillary studies
Keywords
cervical cancer, healing touch, healing touch therapy
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Relaxation trainingBehavioural

    Also called Relaxation

    Muscle relaxation training

  • Therapeutic touchBehavioural

    Also called Healing touch

    Healing Touch (HT) therapy

  • Questionnaire administrationOther

  • Ancillary studiesOther

    Also called Blood draw

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

Study groups in NCT04905576
Study groupRoleWhat they receive
Relaxation training following daily radiationExperimentalAll relaxation sessions will be given individually, and will be provided by trained nurses or research assistants. Patients receiving relaxation will learn exercises to release tension through muscle relaxation, breathing, and imagery
Receives: Behavioral: Relaxation training; Other: Questionnaire administration; Other: Ancillary studies
Healing touch therapy following daily radiationExperimentalAll Healing Touch sessions will be given individually, and will be provided by trained nurses or research assistants. Patients receiving Healing Touch will receive a series of standardized therapeutic techniques designed to promote optimal flow of energy throughout the body.
Receives: Behavioral: Therapeutic touch; Other: Questionnaire administration; Other: Ancillary studies
No interventionActive comparatorThe no intervention group will receive no special intervention other than standard medical care, which includes the regular medical care given by the patient's physician and health care professionals.
Receives: Other: Questionnaire administration; Other: Ancillary studies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in natural killer cell cytotoxicity (NKCC)

    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.

    Measured: 6 weeks

  2. Number of chemoradiation-related toxicities

    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

    Measured: 6 weeks

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

    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

    Measured: 6 weeks

  4. Change in participant reports of depression

    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)

    Measured: 6 weeks

Secondary outcomes (6)

  1. Change in participant reports of anxiety

    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)

    Measured: 6 weeks

  2. Change in white blood cell counts

    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.

    Measured: 6 weeks

  3. Change in red blood cell counts

    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.

    Measured: 6 weeks

  4. Change in participant reports of quality of life

    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).

    Measured: 6 weeks

  5. Change in participant reports of fatigue

    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.

    Measured: 6 weeks

  6. Change in metabolomic measures

    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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2021
  2. Study start4 Jun 2001
  3. Primary completion15 Mar 2008
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients are randomized to relaxation, healing touch, or standard care arms of the study
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04905576
Sponsor's protocol ID
200105058
Status last verified
May 2021
First submitted
20 May 2021
Last updated
27 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lutgendorf SK, Mullen-Houser E, Russell D, Degeest K, Jacobson G, Hart L, Bender D, Anderson B, Buekers TE, Goodheart MJ, Antoni MH, Sood AK, Lubaroff DM. Preservation of immune function in cervical cancer patients during chemoradiation using a novel integrative approach. Brain Behav Immun. 2010 Nov;24(8):1231-40. doi: 10.1016/j.bbi.2010.06.014. Epub 2010 Jun 30.

    PubMed 20600809

  • Hart LK, Freel MI, Haylock PJ, Lutgendorf SK. The use of healing touch in integrative oncology. Clin J Oncol Nurs. 2011 Oct;15(5):519-25. doi: 10.1188/11.CJON.519-525.

    PubMed 21951738

  • van Wietmarschen HA, Area-Gomez E, Picard M, Goodheart MJ, Sood AK, Lutgendorf SK. Metabolic Effects of Healing Touch During Cervical Cancer Treatment: An Exploratory Analysis. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251367793. doi: 10.1177/15347354251367793. Epub 2025 Sep 4.

    PubMed 40908656

Questions about this trial

What is this clinical trial studying?

A study testing Relaxation training, Therapeutic touch and Questionnaire administration in people with Cervical Cancer, run by University of Iowa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in natural killer cell cytotoxicity (NKCC) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04905576, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.

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