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Trial record 9 of 12 for:    Premature Ovarian Failure 14

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
Enrollment 27
Recruitment Details 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  
Arm/Group Title Hypnotherapy Gabapentin
Hide Arm/Group Description 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. Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
Period Title: Overall Study
Started 13 14
Completed 9 [1] 8
Not Completed 4 6
Reason Not Completed
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.
Arm/Group Title Hypnotherapy Gabapentin Total
Hide Arm/Group Description 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. Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily). Total of all reporting groups
Overall Number of Baseline Participants 11 14 25
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 14 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
14
 100.0%
25
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 14 participants 25 participants
Female
11
 100.0%
14
 100.0%
25
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Daily Hot Flashes
Hide Description Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hypnotherapy Gabapentin
Hide Arm/Group Description:
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.
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
Overall Number of Participants Analyzed 7 8
Median (Full Range)
Unit of Measure: daily hot flashes
5
(2 to 11)
4.5
(2 to 9)
2.Primary Outcome
Title Number of Daily Hot Flashes
Hide Description Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). A total of 15 diaries were submitted (7 hypnotherapy, 8 gabapentin). One person in each arm stopped recording in her diary before the 4 week mark.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hypnotherapy Gabapentin
Hide Arm/Group Description:
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.
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
Overall Number of Participants Analyzed 6 7
Median (Full Range)
Unit of Measure: daily hot flashes
4
(1 to 7)
4
(2 to 9)
3.Primary Outcome
Title Number of Daily Hot Flashes
Hide Description Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). One woman in the hypnotherapy arm and 3 women in the gabapentin arm stopped keeping their diary before the 8 week mark.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hypnotherapy Gabapentin
Hide Arm/Group Description:
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.
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
Overall Number of Participants Analyzed 6 5
Median (Full Range)
Unit of Measure: daily hot flashes
1
(0 to 7)
3
(3 to 5.5)
4.Primary Outcome
Title Hot Flash Severity Score
Hide Description The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hypnotherapy Gabapentin
Hide Arm/Group Description:
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.
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
Overall Number of Participants Analyzed 7 8
Median (Full Range)
Unit of Measure: units on a scale (severity score)
10
(2 to 14)
7.5
(2 to 17.5)
5.Primary Outcome
Title Hot Flash Severity Score
Hide Description The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hypnotherapy Gabapentin
Hide Arm/Group Description:
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.
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
Overall Number of Participants Analyzed 6 7
Median (Full Range)
Unit of Measure: units on a scale (severity score)
6.5
(1 to 11)
4
(2 to 17.5)
6.Primary Outcome
Title Hot Flash Severity Score
Hide Description The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hypnotherapy Gabapentin
Hide Arm/Group Description:
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.
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
Overall Number of Participants Analyzed 6 5
Median (Full Range)
Unit of Measure: units on a scale (severity score)
1.5
(0 to 12)
5
(3 to 11.5)
7.Secondary Outcome
Title Hot Flash Related Daily Interference Score (HFRDIS)
Hide Description The HFRDIS is a validated survey of 10 questions asking patients to rate ten symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All women who were randomized were included in the baseline analysis (with the exception of 2 women excluded from the hypnotherapy arm who were deemed ineligible after randomization).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hypnotherapy Gabapentin
Hide Arm/Group Description:
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.
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
Overall Number of Participants Analyzed 11 14
Median (Full Range)
Unit of Measure: units on a scale (HFRDIS)
58
(16 to 64)
45.5
(11 to 82)
8.Secondary Outcome
Title Hot Flash Related Daily Interference Score (HFRDIS)
Hide Description The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). Of 11 eligible women in the hypnotherapy arm, 2 never initiated treatment, and 3 did not complete the survey at this time point. Of the 14 eligible women in the gabapentin arm, 3 never initiated treatment, and 3 dropped out of the study before the 4 week time point.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hypnotherapy Gabapentin
Hide Arm/Group Description:
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.
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
Overall Number of Participants Analyzed 6 8
Median (Full Range)
Unit of Measure: units on a scale (HFRDIS)
25.5
(1 to 57)
21.5
(0 to 57)
9.Secondary Outcome
Title Hot Flash Related Daily Interference Score (HFRDIS)
Hide Description The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All nine women who initiated hypnotherapy treatment completed the survey at the end of 8 weeks. One woman in the gabapentin arm did not submit a survey at 8 weeks.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hypnotherapy Gabapentin
Hide Arm/Group Description:
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.
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
Overall Number of Participants Analyzed 9 7
Median (Full Range)
Unit of Measure: units on a scale (HFRDIS)
26
(0 to 68)
22
(7 to 41)
Time Frame 2 years, 11 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hypnotherapy Gabapentin
Hide Arm/Group Description 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. Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
All-Cause Mortality
Hypnotherapy Gabapentin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Hypnotherapy Gabapentin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Hypnotherapy Gabapentin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/14 (0.00%) 
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.
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
Layout table for Results Point of Contact information
Name/Title: Shannon MacLaughlan, MD
Organization: Stanford Hospital
Phone: 650-724-0456
EMail: smaclaug@stanford.edu
Publications:
Layout table for additonal information
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