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

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

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

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.

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.

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

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.

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.

The practitioner performed a structured interview with the patient both a verbal assessment and an energy/physical assessment using pendulum and hand scan techniques. The practitioner will then provide the intervention which will consist of: chakra connection, magnetic passes (hands still and in motion), magnetic clearing.

Standard massage techniques will be employed over the head, neck, shoulders, back, hands, and/or feet areas. The intensity and rapidity of massage movements will be individualized to the patient's comfort level.

Steps: 1) begins with a progressive relaxation induction; 2) suggestions for deepening are then provided; 3) offered suggestions to increase comfort with medical procedures; 4) suggestion for enhanced capacity for coping will be given as an ego strengthening suggestion, with a post-hypnotic suggestion for increasing comfort/success in coping each time.

Patients will receive 6 cycles of taxane and platinum therapy as prescribed by their treating physician. Chemotherapy treatment is not part of this study.

Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)

Measured by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. It is a standardized self-administered questionnaire measuring many aspects of quality of life (0 to 4; Not at all, A little bit, Some-what, Quite a bit, Very much) as related to patients with ovarian cancers. The quality of life measures include the total FACT-O score (minimum value 0, maximum value 200). Questionnaires are recoded in the final analysis phase so that a higher score reflected more adverse effects on quality of life.

Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy

Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM

The MHI asks questions about how the consumer is feeling and coping with usual life activities. It provides measurable information about the consumer's wellbeing (anxiety, depression, loss of emotional control, general positive affect and emotional ties). A single score based on all items designed as high level summary index of the person's mental health status. High scores on the Mental Health Index indicate greater psychological well being and relatively less psychological distress (range is 38-240).

Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy

Number of patients who had to delay their chemotherapy treatments and or complementary alternative medicine due to side effects.

Determined by averaging the total number of anti-emetic prescriptions given per patient after receiving chemotherapy.

Determined by averaging the total number of anti-emetic prescriptions given per patient after chemotherapy and complementary alternative medicine.

Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient after receiving chemotherapy and complementary alternative medicine.

Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.

Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.

Number of patients that had infections requiring antibiotic therapy or admission to the hospital that received either chemotherapy alone or chemotherapy plus complementary alternative medicine.

Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM

Count of patients who were admitted to the hospital after receiving chemotherapy treatment or chemotherapy plus complementary alternative medicine.

Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM

Average count determined - collected during treatment phase of study - Includes T-helper/inducer, CD4 and CD8 cells; number of CD4 and CD8 cells (in mm^3).

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