Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine

University of Minnesota (UMN)

Status: Completed

Conditions: Peritoneal Primary Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: Standard chemotherapy; Other: massage therapy; Other: hypnosis; Other: healing touch

Study type: Interventional

Funder types: Other

Identifiers

NCT00293293

0012M77821 (Other Identifier)

UMN-WCC-30 (Other Identifier)

2000NT790

Details and patient eligibility

About

RATIONALE: 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, massage therapy and healing touch changes outcomes in women receiving chemotherapy for newly diagnosed epithelial ovarian, fallopian tube or peritoneal cavity cancer.

Full description

OBJECTIVES:

Primary

• Determine whether quality of life is improved in patients with epithelial ovarian, fallopian tube 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 epithelial ovarian, fallopian tube 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 with each course of chemotherapy 1-6 and hypnosis 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.

Enrollment: 43 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer, any pathologic type or stage, who will receive 6 cycles of chemotherapy.
• Patients must have signed an informed consent

Exclusion criteria

• Previous cancer other than skin cancer
• Previous chemotherapy experience
• Active substance abuse
• Schizophrenia
• Pregnant or lactating

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Chemotherapy Alone

Active Comparator group

Description:

Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or primary peritoneal cancer by their treating physician. Chemotherapy administration is not administered as part of this protocol.

Treatment:

Drug: Standard chemotherapy

Standard Chemotherapy + CAM

Experimental group

Description:

Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or peritoneal cancer with additional complementary alternative medicine - CAM (healing touch, hypnosis and massage therapy). Chemotherapy administration is not administered as part of this protocol.

Treatment:

Other: healing touch

Other: hypnosis

Other: massage therapy