Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Completed · Phase 2 · Has a placebo group

Conditions studied: Hot Flashes

In brief

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).

Key facts

Study ID

NCT01005108

Run by

Abramson Cancer Center at Penn Medicine

People needed

120

Starts

2009-01-01

Expected to finish

2014-01-31

Last updated by the study team

2020-04-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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.

Where it is running

• Abramson Cancer Center of the Unviersity of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.