Hot FlashesPhase 2NCT01005108
Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors
A Phase 2 study testing Gabapentin in people with Hot Flashes, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Overall Objectives: The overarching goal is to compare the effectiveness of acupuncture and gabapentin to their respective placebo controls in the treatment of hot flashes in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to 31 Jan 2014
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years or older with a history of Stage I, II or III breast cancer for at least 12 months.
- Have been seen by an oncologist within the previous 6-month period and determined to be free of disease by clinical examination and history;
- Experienced at least two hot flashes daily over the seven-day screening period as based on the Daily Hot Flash Diary.
- Hot flashes have been present for at least a month before study entry.
- Willing to use non-hormonal contraceptives during the duration of the study if patient is premenopausal.
Who cannot join
- Having metastatic breast cancer ( IV)
- Currently on chemotherapy or radiation therapy as adjuvant treatment
- Started hormonal therapies such as tamoxifen or aromatase inhibitors within the last 4 weeks; or plan to change or terminate hormonal therapies in the next 14 weeks.
- Started or changed with treatments for hot flashes, such as SSRIs or clonidine within the last 4 weeks; or plan to change or terminate these therapies in the next 14 weeks.
- Current use of estrogen and/or progestin.
- Pregnancy
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- Breast feeding
- Bleeding disorder or current use of warfarin or heparin by patient history because of the use of needles.
- Previous use of gabapentin for hot flashes.
- Current use of any anti-convulsant.
- Renal dysfunction defined as serum creatinine concentration above 1.25 times the upper limit of normal
- Known allergy to gabapentin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the Unviersity of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Overall Objectives: The overarching goal is to compare the effectiveness of acupuncture and gabapentin to their respective placebo controls in the treatment of hot flashes in breast cancer patients. The investigators primary specific aim will focus on determining the magnitude of response to placebo acupuncture versus placebo pills on hot flashes (HFs).
- Conditions
- Hot Flashes
- Being tested
- Gabapentin
- Keywords
- Hot Flashes for Breast Cancer Patients
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes
| Study group | Role | What they receive |
|---|---|---|
| placebo pill | Experimental | Not described Receives: Drug: Gabapentin |
| placebo accupuncture | Experimental | Not described Receives: Drug: Gabapentin |
| accupuncture | Experimental | Not described Receives: Drug: Gabapentin |
| gabapentin | Experimental | Not described Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Hot Flash Diary (DHFD)-Primary Outcome (2 minutes per day)
Measured: Daily starting from baseline until week 12 and again for one week at week 24.
Secondary outcomes (10)
Demographics -Covariates
Measured: 5 minutes
Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome
Measured: 3 minutes
Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome
Measured: 6 minutes
Brief Fatigue Inventory (BFI) - Secondary Outcome
Measured: 3 minutes
HADS - Secondary Outcome
Measured: 2 minutes
Global Assessment Scale -Secondary Outcome
Measured: 30 seconds
Acupuncture Expectancy Scale (AES) - Secondary Aim
Measured: 1 minute
Creditability Rating of Acupuncture - Secondary Aim
Measured: 1 minute
Medication and CAM Usage -Covariates
Measured: 5 minutes
Actigraph Movement Measuring Device
Measured: 24 hrs/day for 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startJan 2009
- Primary completion31 Jan 2014
- Study completion31 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun J Mao, MD, MSCE, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005108
- Sponsor's protocol ID
- UPCC 16108
- Other IDs
- NCI-2009-01315
- Status last verified
- Apr 2020
- First submitted
- 29 Oct 2009
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Romero SAD, Li QS, Orlow I, Gonen M, Su HI, Mao JJ. Genetic predictors to acupuncture response for hot flashes: an exploratory study of breast cancer survivors. Menopause. 2020 Aug;27(8):913-917. doi: 10.1097/GME.0000000000001545.
PubMed 32217888Garland SN, Xie SX, Li Q, Seluzicki C, Basal C, Mao JJ. Comparative effectiveness of electro-acupuncture versus gabapentin for sleep disturbances in breast cancer survivors with hot flashes: a randomized trial. Menopause. 2017 May;24(5):517-523. doi: 10.1097/GME.0000000000000779.
PubMed 27875389Mao JJ, Bowman MA, Xie SX, Bruner D, DeMichele A, Farrar JT. Electroacupuncture Versus Gabapentin for Hot Flashes Among Breast Cancer Survivors: A Randomized Placebo-Controlled Trial. J Clin Oncol. 2015 Nov 1;33(31):3615-20. doi: 10.1200/JCO.2015.60.9412. Epub 2015 Aug 24.
PubMed 26304905
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01005108
- Acronym / sponsor ID
- UPCC 16108
- Conditions
- Hot Flashes
- Keywords
- Hot Flashes for Breast Cancer Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- 31 Jan 2014 (actual)
- Study completion
- 31 Jan 2014 (actual)
- First posted
- 30 Oct 2009 (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.
Overall Objectives: The overarching goal is to compare the effectiveness of acupuncture and gabapentin to their respective placebo controls in the treatment of hot flashes in breast cancer patients. The investigators primary specific aim will focus on determining the magnitude of response to placebo acupuncture versus placebo pills on hot flashes (HFs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo pill | Experimental | Drug: Gabapentin |
| placebo accupuncture | Experimental | Drug: Gabapentin |
| accupuncture | Experimental | Drug: Gabapentin |
| gabapentin | Experimental | Drug: Gabapentin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women 18 years or older with a history of Stage I, II or III breast cancer for at least 12 months.
- Have been seen by an oncologist within the previous 6-month period and determined to be free of disease by clinical examination and history;
- Experienced at least two hot flashes daily over the seven-day screening period as based on the Daily Hot Flash Diary.
- Hot flashes have been present for at least a month before study entry.
- Willing to use non-hormonal contraceptives during the duration of the study if patient is premenopausal.
Key exclusion criteria (12 listed)
- Having metastatic breast cancer ( IV)
- Currently on chemotherapy or radiation therapy as adjuvant treatment
- Started hormonal therapies such as tamoxifen or aromatase inhibitors within the last 4 weeks; or plan to change or terminate hormonal therapies in the next 14 weeks.
- Started or changed with treatments for hot flashes, such as SSRIs or clonidine within the last 4 weeks; or plan to change or terminate these therapies in the next 14 weeks.
- Current use of estrogen and/or progestin.
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 |
|---|---|---|
| GabapentinUse of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes | Drug | accupuncture, gabapentin, placebo accupuncture, placebo pill |
Primary outcome
Daily Hot Flash Diary (DHFD)-Primary Outcome (2 minutes per day)
Time frame: Daily starting from baseline until week 12 and again for one week at week 24.
10 secondary outcomes
Demographics -Covariates
Time frame: 5 minutes
Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome
Time frame: 3 minutes
Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome
Time frame: 6 minutes
Brief Fatigue Inventory (BFI) - Secondary Outcome
Time frame: 3 minutes
HADS - Secondary Outcome
Time frame: 2 minutes
Global Assessment Scale -Secondary Outcome
Time frame: 30 seconds
Acupuncture Expectancy Scale (AES) - Secondary Aim
Time frame: 1 minute
Creditability Rating of Acupuncture - Secondary Aim
Time frame: 1 minute
Medication and CAM Usage -Covariates
Time frame: 5 minutes
Actigraph Movement Measuring Device
Time frame: 24 hrs/day for 3 days
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 Apr 2020.
- Derived from this study: PubMed 32217888Romero SAD, Li QS, Orlow I, Gonen M, Su HI, Mao JJ. Genetic predictors to acupuncture response for hot flashes: an exploratory study of breast cancer survivors. Menopause. 2020 Aug;27(8):913-917. doi: 10.1097/GME.0000000000001545.
- Derived from this study: PubMed 27875389Garland SN, Xie SX, Li Q, Seluzicki C, Basal C, Mao JJ. Comparative effectiveness of electro-acupuncture versus gabapentin for sleep disturbances in breast cancer survivors with hot flashes: a randomized trial. Menopause. 2017 May;24(5):517-523. doi: 10.1097/GME.0000000000000779.
- Derived from this study: PubMed 26304905Mao JJ, Bowman MA, Xie SX, Bruner D, DeMichele A, Farrar JT. Electroacupuncture Versus Gabapentin for Hot Flashes Among Breast Cancer Survivors: A Randomized Placebo-Controlled Trial. J Clin Oncol. 2015 Nov 1;33(31):3615-20. doi: 10.1200/JCO.2015.60.9412. Epub 2015 Aug 24.
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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.
Jun J Mao, MD, MSCE principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gabapentin in people with Hot Flashes, run by Abramson Cancer Center at Penn Medicine at 1 site 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?
The sponsor lists 5 inclusion and 12 exclusion criteria. 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 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Daily Hot Flash Diary (DHFD)-Primary Outcome (2 minutes per day) (time frame: Daily starting from baseline until week 12 and again for one week at week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01005108, which also lists 3 linked publications.
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 Apr 2020.