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OpenTrials
Completed

NCT Number: NCT01005108

Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Abramson Cancer Center of the Unviersity of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Gabapentin

Drug

Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes

Primary outcomes

  1. 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.

Secondary outcomes

  1. Demographics -Covariates

    Time frame: 5 minutes

  2. Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome

    Time frame: 3 minutes

  3. Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome

    Time frame: 6 minutes

  4. Brief Fatigue Inventory (BFI) - Secondary Outcome

    Time frame: 3 minutes

  5. HADS - Secondary Outcome

    Time frame: 2 minutes

  6. Global Assessment Scale -Secondary Outcome

    Time frame: 30 seconds

  7. Acupuncture Expectancy Scale (AES) - Secondary Aim

    Time frame: 1 minute

  8. Creditability Rating of Acupuncture - Secondary Aim

    Time frame: 1 minute

  9. Medication and CAM Usage -Covariates

    Time frame: 5 minutes

  10. Actigraph Movement Measuring Device

    Time frame: 24 hrs/day for 3 days

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Oct 30, 2009
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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