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Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes.

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ClinicalTrials.gov Identifier: NCT00711529
Recruitment Status : Completed
First Posted : July 9, 2008
Results First Posted : June 24, 2013
Last Update Posted : June 24, 2013
Sponsor:
Information provided by (Responsible Party):
Shannon MacLaughlan, Women and Infants Hospital of Rhode Island

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Hot Flashes
Interventions: Behavioral: Hypnotherapy
Drug: gabapentin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between September 2008 and September 2010, 73 women were screened for this study. Fourteen women were deemed ineligible and 32 decided not to participate. A total of 27 women were randomized to receive treatment, 14 to gabapentin and 13 to hypnotherapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hypnotherapy Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
Gabapentin Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).

Participant Flow:   Overall Study
    Hypnotherapy   Gabapentin
STARTED   13   14 
COMPLETED   9 [1]   8 
NOT COMPLETED   4   6 
Protocol Violation                2                0 
Withdrawal by Subject                2                6 
[1] 2 women lost their hot flash diary, so only 7 patients were evaluable for primary endpoint.



  Baseline Characteristics

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.
Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initate treatment and did not submit diaries. Two women lost their diaries, leaving 7 diaries for analysis. Of the 14 women randomized to receive gabapentin, 6 dropped out and did not submit diaries.

Reporting Groups
  Description
Hypnotherapy Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
Gabapentin Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
Total Total of all reporting groups

Baseline Measures
   Hypnotherapy   Gabapentin   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   14   25 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   11   14   25 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   11   14   25 
Male   0   0   0 


  Outcome Measures

1.  Primary:   Number of Daily Hot Flashes   [ Time Frame: Baseline ]

2.  Primary:   Number of Daily Hot Flashes   [ Time Frame: Week 4 ]

3.  Primary:   Number of Daily Hot Flashes   [ Time Frame: Week 8 ]

4.  Primary:   Hot Flash Severity Score   [ Time Frame: Baseline ]

5.  Primary:   Hot Flash Severity Score   [ Time Frame: Week 4 ]

6.  Primary:   Hot Flash Severity Score   [ Time Frame: Week 8 ]

7.  Secondary:   Hot Flash Related Daily Interference Score (HFRDIS)   [ Time Frame: Baseline ]

8.  Secondary:   Hot Flash Related Daily Interference Score (HFRDIS)   [ Time Frame: Week 4 ]

9.  Secondary:   Hot Flash Related Daily Interference Score (HFRDIS)   [ Time Frame: Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We were unable to meet recruitment goals because of 1) lower-than-anticipated rate of referrals, and 2) subjects' unwillingness to randomization. This resulted in small numbers that limit interpretation of results.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Shannon MacLaughlan, MD
Organization: Stanford Hospital
phone: 650-724-0456
e-mail: smaclaug@stanford.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shannon MacLaughlan, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT00711529     History of Changes
Other Study ID Numbers: 08-0057
First Submitted: July 3, 2008
First Posted: July 9, 2008
Results First Submitted: March 5, 2012
Results First Posted: June 24, 2013
Last Update Posted: June 24, 2013