Healing Touch and Relaxation Therapies in Cervical Cancer... | NCT00084123

Studies
Healing Touch and Relaxation Therapies in Cervical Cancer Patients

NCT00084123

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Status

Completed

Last Update Posted

Jul 10, 2009Estimated

Enrollment

60Actual

Phase

Phase 2

Conditions

Cervix Neoplasms

Interventions

Healing Touch Therapy
Relaxation Therapy
Standard Care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Jun 7, 2004

First Submission Date that Met QC Criteria

Jun 7, 2004

First Posted Date

Jun 8, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2009

Last Update Posted Date

Jul 10, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Center for Complementary and Integrative Health (NCCIH)NIH

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healing Touch	Experimental	Healing Touch Therapy	Behavioral: Healing Touch Therapy
Relaxation Therapy	Active Comparator	Relaxation Therapy	Behavioral: Relaxation Therapy
Standard Care	Placebo Comparator	Standard Care	Behavioral: Standard Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Healing Touch Therapy	Behavioral		Healing Touch
Relaxation Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
natural killer cell cytotoxicity		Baseline to week 6
T-cell counts		Baseline to week 6
side effects		Baseline to week 6

Secondary Outcomes

Measure	Description	Time Frame
distress		Baseline to week 6
WBC and RBC		Baseline to week 6
days of treatment delay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan K Lutgendorf, MD	University of Iowa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Iowa Hospital and Clinics		Iowa City	Iowa	52242	United States

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012064	Relaxation Therapy
D059039	Standard of Care

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D001521	Behavior Therapy

Browse Leaves

Not provided

Browse Branches

Not provided