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

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ClinicalTrials.gov Identifier: NCT00293293
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : June 6, 2012
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
Randy Shaver Cancer Research Fund
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Tracking Information
First Submitted Date  ICMJE February 16, 2006
First Posted Date  ICMJE February 17, 2006
Results First Submitted Date  ICMJE August 22, 2011
Results First Posted Date  ICMJE June 6, 2012
Last Update Posted Date December 28, 2017
Study Start Date  ICMJE May 2005
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
  • Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) [ Time Frame: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy ]
    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.
  • Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM [ Time Frame: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy ]
    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).
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
  • Number of Patients With Delays In Receiving Chemotherapy Alone [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
    Number of patients who had to delay their chemotherapy treatments due to side effects.
  • Number of Patients With Delays In Receiving Chemotherapy Plus CAM [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
    Number of patients who had to delay their chemotherapy treatments and or complementary alternative medicine due to side effects.
  • Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
    Determined by averaging the total number of anti-emetic prescriptions given per patient after receiving chemotherapy.
  • Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
    Determined by averaging the total number of anti-emetic prescriptions given per patient after chemotherapy and complementary alternative medicine.
  • Average Anti-Emetic Dose Use After Chemotherapy Alone [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
    Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient.
  • Average Anti-Emetic Dose Use After Chemotherapy Plus CAM [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
    Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient after receiving chemotherapy and complementary alternative medicine.
  • Average Natural Killer Cell Count Levels Before Chemotherapy Alone [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
    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.
  • Average Natural Killer Cell Count Levels Before Chemotherapy and CAM [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
    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.
  • Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
    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 [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
    Count of patients who were admitted to the hospital after receiving chemotherapy treatment or chemotherapy plus complementary alternative medicine.
  • Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM [ Time Frame: Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months) ]
    Determined from white blood cell counts collected during treatment phase of study; average applied.
  • Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
    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).
  • Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
    Determined from collection of saliva during treatment phase of study and recorded in mg/dL units.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
Official Title  ICMJE Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
Brief Summary

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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Ovarian Cancer
  • Peritoneal Primary Cancer
  • Fallopian Tube Cancer
Intervention  ICMJE
  • Other: healing touch
    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.
    Other Name: energy-based therapy
  • Other: massage therapy
    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.
    Other Name: massage
  • Other: hypnosis
    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.
    Other Name: mind-body intervention procedure
  • Drug: Standard chemotherapy
    Patients will receive 6 cycles of taxane and platinum therapy as prescribed by their treating physician. Chemotherapy treatment is not part of this study.
    Other Names:
    • Taxane
    • Platinum
Study Arms  ICMJE
  • Active Comparator: Chemotherapy Alone
    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.
    Intervention: Drug: Standard chemotherapy
  • Experimental: Standard Chemotherapy + CAM
    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.
    Interventions:
    • Other: healing touch
    • Other: massage therapy
    • Other: hypnosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2012)
43
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00293293
Other Study ID Numbers  ICMJE 2000NT790
UMN-WCC-30 ( Other Identifier: Women's Cancer Center, University of Minnesota )
0012M77821 ( Other Identifier: IRB, University of Minnesota )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Randy Shaver Cancer Research Fund
Investigators  ICMJE
Study Chair: Patricia L. Judson, MD Moffitt
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP