Anxiety DisorderNCT00022074
Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
A study testing gabapentin and quality-of-life assessment in people with Anxiety Disorder and Breast Cancer, run by Gary Morrow at 18 sites in United States.
Trial summary
RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes. PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer. Read more about this study
- Who is it for?
- Ages Up to 120 years, women only
- Conditions the study is for
- Anxiety Disorder, Breast Cancer, Depression
- What is being tested?
- gabapentin and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 18 sitesUnited States
- Study dates
- Jul 2001to Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Experiencing 2 or more hot flashes per day for at least 1 week
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Not specified
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin normal
- SGOT no greater than 2 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 1.25 times ULN
Cardiovascular:
- No coronary insufficiency
- No myocardial infarction within the past 3 months
- No symptomatic cardiac disease
- No peripheral vascular disease
- No cerebrovascular disease or stroke
- No syncope or symptomatic hypotension
Other:
- No history of allergic or other adverse reaction to gabapentin
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 1 week after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No other concurrent anticonvulsant medication
- No concurrent clonidine or venlafaxine
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
CCOP - Columbus
Columbus, Ohio, 43206
CCOP - Dayton
Dayton, Ohio, 45429
CCOP - Central Illinois
Decatur, Illinois, 62526
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80224
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - North Shore University Hospital
Manhasset, New York, 11030
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
CCOP - Northwest
Tacoma, Washington, 98405-0986
CCOP - Wichita
Wichita, Kansas, 67214-3882
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
About this study
Official title: Control of Vasomotor Symptoms in Women Treated for Breast Cancer
RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes.
PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.
Read the detailed description
OBJECTIVES:
- Compare the effectiveness and side effects of 2 different doses of gabapentin vs placebo for the control of hot flashes and other vasomotor symptoms in women with breast cancer.
- Compare quality of life, anxiety, and depression in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and duration of hot flash symptoms (less than 9 months vs 9 or more months). Patients are randomized to 1 of 3 arms.
- Arm I: Patients receive oral placebo 3 times a day.
- Arm II: Patients receive oral gabapentin at a low dose 3 times a day.
- Arm III: Patients receive oral gabapentin as in arm II for 3 days and then at a high dose 3 times a day.
Treatment on all arms continues for 8 weeks in the absence of unacceptable toxicity. After week 8, patients may receive open-label gabapentin at the discretion of their physicians.
Hot flashes are assessed at baseline and then during weeks 3 and 7 of the study.
Quality of life, anxiety, and depression are assessed at baseline and then at weeks 4 and 8.
Patients are followed at week 12.
PROJECTED ACCRUAL: A total of 408 patients (136 per arm) will be accrued for this study within 18 months.
- Conditions
- Anxiety Disorder, Breast Cancer, Depression, Hot Flashes
- Being tested
- gabapentin, quality-of-life assessment
- Keywords
- stage I breast cancer, stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, anxiety disorder, depression, hot flashes
- Medical subject headings
- Anxiety Disorders, Breast Neoplasms, Depression, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gabapentinDrug
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 2001
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Gary Morrow
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Gary Morrow, University of Rochester NCORP Research Base
- Investigators
- Kishan J. Pandya, MD, Study chair, James P. Wilmot Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022074
- Sponsor's protocol ID
- CDR0000068780
- Other IDs
- URCC-U2101, NCI-P01-0183
- Status last verified
- Oct 2015
- First submitted
- 10 Aug 2001
- Last updated
- 15 Oct 2015
- Results posted
- No
Publications
Pandya KJ, Morrow GR, Roscoe JA, Zhao H, Hickok JT, Pajon E, Sweeney TJ, Banerjee TK, Flynn PJ. Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial. Lancet. 2005 Sep 3-9;366(9488):818-24. doi: 10.1016/S0140-6736(05)67215-7.
PubMed 16139656
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Vasomotor Symptoms in Women Treated for Breast Cancer
- ClinicalTrials.gov ID
- NCT00022074
- Acronym / sponsor ID
- CDR0000068780
- Conditions
- Anxiety Disorder, Breast Cancer, Depression, Hot Flashes
- Keywords
- stage I breast cancer, stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, anxiety disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Gary MorrowUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2001
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes.
PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.
Detailed description
OBJECTIVES:
- Compare the effectiveness and side effects of 2 different doses of gabapentin vs placebo for the control of hot flashes and other vasomotor symptoms in women with breast cancer.
- Compare quality of life, anxiety, and depression in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and duration of hot flash symptoms (less than 9 months vs 9 or more months). Patients are randomized to 1 of 3 arms.
- Arm I: Patients receive oral placebo 3 times a day.
- Arm II: Patients receive oral gabapentin at a low dose 3 times a day.
- Arm III: Patients receive oral gabapentin as in arm II for 3 days and then at a high dose 3 times a day.
Treatment on all arms continues for 8 weeks in the absence of unacceptable toxicity. After week 8, patients may receive open-label gabapentin at the discretion of their physicians.
Hot flashes are assessed at baseline and then during weeks 3 and 7 of the study.
Quality of life, anxiety, and depression are assessed at baseline and then at weeks 4 and 8.
Patients are followed at week 12.
PROJECTED ACCRUAL: A total of 408 patients (136 per arm) will be accrued for this study within 18 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gabapentin | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
- Results publication: PubMed 16139656Pandya KJ, Morrow GR, Roscoe JA, Zhao H, Hickok JT, Pajon E, Sweeney TJ, Banerjee TK, Flynn PJ. Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial. Lancet. 2005 Sep 3-9;366(9488):818-24. doi: 10.1016/S0140-6736(05)67215-7.
Related trials for Anxiety Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kishan J. Pandya, MD study chair
James P. Wilmot Cancer Center
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gabapentin and quality-of-life assessment in people with Anxiety Disorder and Breast Cancer, run by Gary Morrow at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00022074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2015.