Cervix NeoplasmsPhase 2NCT00084123
Healing Touch and Relaxation Therapies in Cervical Cancer Patients
A Phase 2 study testing Healing Touch Therapy and Relaxation Therapy in people with Cervix Neoplasms, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Neoplasms
- What is being tested?
- Healing Touch Therapy and Relaxation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Apr 2007
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage Ib1-IVa cervical cancer
- Treatment with concurrent chemotherapy and radiation at the University of Iowa Hospitals and Clinics
Who cannot join
- Immunosuppressive disorders
- Use of immunosuppressive medications
- Transplant recipient
- Metastatic or recurrent cervical cancer
- History of any other type of cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Healing Touch in Advanced Cervical Cancer Patients: Immune Effects and Mechanisms
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.
Read the detailed 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.
- Conditions
- Cervix Neoplasms
- Being tested
- Healing Touch Therapy, Relaxation Therapy, Standard Care
- Keywords
- Relaxation Techniques, Radiation, Drug Therapy, Healing Touch
- 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.
Healing Touch TherapyBehavioural
Relaxation TherapyBehavioural
Standard CareBehavioural
Standard Care
| Study group | Role | What they receive |
|---|---|---|
| Healing Touch | Experimental | Healing Touch Therapy Receives: Behavioral: Healing Touch Therapy |
| Relaxation Therapy | Active comparator | Relaxation Therapy Receives: Behavioral: Relaxation Therapy |
| Standard Care | Placebo comparator | Standard Care Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
natural killer cell cytotoxicity
Measured: Baseline to week 6
T-cell counts
Measured: Baseline to week 6
side effects
Measured: Baseline to week 6
Secondary outcomes (4)
distress
Measured: Baseline to week 6
WBC and RBC
Measured: Baseline to week 6
days of treatment delay
Measured: Baseline to week 6
salivary cortisol
Measured: Baseline to post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2004 (estimated)
- Study startSep 2002
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Susan K Lutgendorf, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084123
- Sponsor's protocol ID
- P20AT000756-01
- Status last verified
- Jul 2009
- First submitted
- 7 Jun 2004
- Last updated
- 10 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Touch in Advanced Cervical Cancer Patients: Immune Effects and Mechanisms
- ClinicalTrials.gov ID
- NCT00084123
- Acronym / sponsor ID
- P20AT000756-01
- Conditions
- Cervix Neoplasms
- Keywords
- Relaxation Techniques, Radiation, Drug Therapy, Healing Touch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 8 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healing Touch | Experimental | Behavioral: Healing Touch TherapyHealing Touch Therapy |
| Relaxation Therapy | Active comparator | Behavioral: Relaxation TherapyRelaxation Therapy |
| Standard Care | Placebo comparator | Behavioral: Standard CareStandard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stage Ib1-IVa cervical cancer
- Treatment with concurrent chemotherapy and radiation at the University of Iowa Hospitals and Clinics
Key exclusion criteria (5 listed)
- Immunosuppressive disorders
- Use of immunosuppressive medications
- Transplant recipient
- Metastatic or recurrent cervical cancer
- History of any other type of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healing Touch Therapy | Behavioural | Healing Touch |
| Relaxation Therapy | Behavioural | Relaxation Therapy |
| Standard CareStandard Care | Behavioural | Standard Care |
Primary outcome
natural killer cell cytotoxicity
Time frame: Baseline to week 6
T-cell counts
Time frame: Baseline to week 6
side effects
Time frame: Baseline to week 6
4 secondary outcomes
distress
Time frame: Baseline to week 6
WBC and RBC
Time frame: Baseline to week 6
days of treatment delay
Time frame: Baseline to week 6
salivary cortisol
Time frame: Baseline to post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2009.
Related trials for Cervix Neoplasms
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Enrolling by invitationObservational study
Use of cfDNA in Monitoring and Guiding Treatment for Cervical Cancer
Cervical Cancer Screening
RecruitingPhase 4
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Cervical Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan K Lutgendorf, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Healing Touch Therapy and Relaxation Therapy in people with Cervix Neoplasms, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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 2 inclusion and 5 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 10 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
natural killer cell cytotoxicity (time frame: Baseline to week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2009.