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Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Hot Flashes

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Trial Information

Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors


Inclusion Criteria:



1. Women 18 years or older with a history of Stage I, II or III breast cancer for at
least 12 months.

2. Have been seen by an oncologist within the previous 6-month period and determined to
be free of disease by clinical examination and history;

3. Experienced at least two hot flashes daily over the seven-day screening period as
based on the Daily Hot Flash Diary.

4. Hot flashes have been present for at least a month before study entry.

5. Willing to use non-hormonal contraceptives during the duration of the study if
patient is premenopausal.

Exclusion Criteria:

1. Having metastatic breast cancer ( IV)

2. Currently on chemotherapy or radiation therapy as adjuvant treatment

3. 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.

4. 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.

5. Current use of estrogen and/or progestin.

6. Pregnancy

7. Breast feeding

8. Bleeding disorder or current use of warfarin or heparin by patient history because of
the use of needles.

9. Previous use of gabapentin for hot flashes.

10. Current use of any anti-convulsant.

11. Renal dysfunction defined as serum creatinine concentration above 1.25 times the
upper limit of normal

12. Known allergy to gabapentin.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Daily Hot Flash Diary (DHFD)-Primary Outcome (2 minutes per day)

Outcome Time Frame:

Daily starting from baseline until week 12 and again for one week at week 24.

Safety Issue:

No

Principal Investigator

Jun J Mao, MD, MSCE

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 16108

NCT ID:

NCT01005108

Start Date:

January 2009

Completion Date:

March 2014

Related Keywords:

  • Hot Flashes
  • Hot Flashes for Breast Cancer Patients
  • Breast Neoplasms
  • Hot Flashes

Name

Location

Abramson Cancer Center of the Unviersity of PennsylvaniaPhiladelphia, Pennsylvania  19104