Hypnosis, Massage Therapy, and Healing Touch in Treating Patients Receiving Chemotherapy for Ovarian Epithelial Cancer or Peritoneal Cavity Cancer - Full Text View

Sponsors and Collaborators:	Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00293293

Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hypnosis, massage therapy, and healing touch may improve the quality of life of patients who are undergoing chemotherapy.

PURPOSE: This randomized clinical trial is studying how well giving hypnosis together with massage therapy and healing touch works in treating patients receiving chemotherapy for newly diagnosed ovarian epithelial cancer or peritoneal cavity cancer.

Condition	Intervention
Ovarian Cancer Peritoneal Cavity Cancer	Procedure: energy therapy Procedure: management of therapy complications Procedure: massage therapy Procedure: mind-body intervention procedure

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized
Official Title:	Outcomes in Ovarian Cancer Patients Using Complementary Alternative Modalities

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	40
Study Start Date:	May 2005

Detailed Description:

OBJECTIVES:

Primary

Determine whether quality of life is improved in patients with ovarian epithelial or primary peritoneal cavity cancer receiving hypnosis, massage therapy, and healing touch and standard chemotherapy as compared to patients receiving standard chemotherapy alone.

Secondary

Determine changes in immunologic response markers, chemotherapy side effects, and complication rates in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I (standard therapy): Patients undergo standard chemotherapy for ovarian epithelial or primary peritoneal cancer.
Arm II (standard therapy with complementary alternative medicine): Patients undergo chemotherapy as in arm I. Patients also undergo massage over approximately 30 minutes and healing touch therapy over approximately 30 minutes once during courses 1-6 and hypnosis once over 30-60 minutes during courses 1, 2, and 4. Quality of life is assessed at baseline, during courses 3 and 6 of chemotherapy, and then 6 months after completion of study treatment.

After completion of study treatment, patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Newly diagnosed ovarian epithelial or primary peritoneal cancer
- Any stage disease
- Any pathologic type
Planning 6 courses of standard chemotherapy

PATIENT CHARACTERISTICS:

Not pregnant or nursing
No schizophrenia
No active substance abuse
No prior cancer except skin cancer

PRIOR CONCURRENT THERAPY:

No prior chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293293

Locations

United States, Minnesota
Masonic Cancer Center at University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

National Cancer Institute (NCI)

Investigators

Study Chair:

Patricia L. Judson, MD

Masonic Cancer Center, University of Minnesota

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000451886, UMN-2000NT790, UMN-WCC-30
Study First Received:	February 16, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00293293 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer

Study placed in the following topic categories:

Ovarian Neoplasms
Digestive System Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian Epithelial Cancer
Abdominal Neoplasms

Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Ovarian Cancer
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Abdominal Neoplasms

Adnexal Diseases
Genital Diseases, Female
Neoplasms
Digestive System Diseases
Neoplasms by Site
Peritoneal Diseases
Peritoneal Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009