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

This study has been completed.
Sponsor:
Collaborator:
Randy Shaver Cancer Research Fund
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00293293
First received: February 16, 2006
Last updated: May 2, 2012
Last verified: May 2012
Results First Received: August 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Ovarian Cancer
Peritoneal Primary Cancer
Fallopian Tube Cancer
Interventions: Other: healing touch
Other: massage therapy
Other: hypnosis
Drug: Standard chemotherapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible patients made informed consent and were randomized to chemotherapy alone or chemotherapy with complementary alternative medicine (hypnosis, massage, healing touch). Patients received either intravenous paclitaxel and carboplatin on an every 3 week basis, or a combination of intravenous and intraperitoneal paclitaxel and cisplatin.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Analysis was conducted as intent-to-treat. All randomized patients were included, regardless of number of courses of chemotherapy, CAM therapy or survival. All women in the CAM arm of the trial received all prescribed CAM interventions. No investigational drugs were administered as a part of this protocol.

Reporting Groups
  Description
Chemotherapy Alone Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
Chemotherapy + CAM Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).

Participant Flow:   Overall Study
    Chemotherapy Alone     Chemotherapy + CAM  
STARTED     20     23  
COMPLETED     18     21  
NOT COMPLETED     2     2  
Withdrawal by Subject                 1                 1  
Patient "too anxious" to complete trial                 1                 0  
Patient discontinued chemotherapy                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Chemotherapy Alone Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
Chemotherapy + CAM Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
Total Total of all reporting groups

Baseline Measures
    Chemotherapy Alone     Chemotherapy + CAM     Total  
Number of Participants  
[units: participants]
  20     23     43  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     16     27  
>=65 years     9     7     16  
Age  
[units: years]
Mean ± Standard Deviation
  63.0  ± 11.4     58.8  ± 11.8     60.72  ± 11.67  
Gender  
[units: participants]
     
Female     20     23     43  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     20     23     43  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Secondary:   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) ]

4.  Secondary:   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) ]

5.  Secondary:   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) ]

6.  Secondary:   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) ]

7.  Secondary:   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) ]

8.  Secondary:   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) ]

9.  Secondary:   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) ]

10.  Secondary:   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) ]

11.  Secondary:   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) ]

12.  Secondary:   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) ]

13.  Secondary:   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) ]

14.  Secondary:   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) ]

15.  Secondary:   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) ]


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