Preliminary analysis of the pilot study using gabapentin on tamoxifen-induced hot flashes in women with breast cancer

A. R. Thummala, J. Griggs, Joseph D Rosenblatt, D. Sahasrabudhe, T. Guttuso, G. R. Morrow, K. J. Pandya

Research output: Contribution to journalArticle

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Abstract

Background: Hot Flashes are symptoms of vasomotor instability. They are reported in at least 50%-57% of women taking tamoxifen. No single agent has been shown to completely eliminate these distressing symptoms, thus the need exists to study newer agents. A clinically significant 94% reduction in hoi flash frequency, in six menopausal women taking gabapentin for other reasons, was recently reported.(Guttuso, T. Neurology 54: 2161-2163, 2000). Anecdotal experience from six women with breast cancer treated with gabapentin 300mg orally three times daily reported marked reduction in hot flash frequency. Objective: To investigate the potential effect of oral gabapentin, for the control of tamoxifen-induced hot flashes in women with breasl cancer. Design: Open-label pilot study conducted at University of Rochester Cancer Center Oncology Program. Patients: 17 postmenopausal women with breast cancer on tamoxifen therapy and having at least one hot flash a day were enrolled on the study. Women on concurrent chemotherapy, uncontrolled hypertension, cardiac disease, hepatic dysfunction who require drugs like SSRIs, MAO inhibitors or other antidepressants were excluded from the study, intervention: Oral Gabapentin. 300 mg three times a day for four weeks. Measurements: In a daily diary, patients recorded number, duration, and severity of hot flashes and overall quality-of-life score (on a 10-point scale) during a 1-week baseline period and 1st and 4th weeks of treatment. Quality of life assessment was based on measures used by the post-menopausal estrogen/ progesterone intervention trial (PEPI). Results: A total of 14 patients completed the 4-week study. 3 women were taken off study due to side effects. Data collected on 12/14 women showed a mean decrease in hot flash duration of 66% (p=. 085), frequency 38% (p=. 001), and severity 47% (p=. 000). Nine women reported 18% improvement in quality of life (p=. 056). Three women had complete elimination of hot Hashes and continued on the drug post study. The drug was well tolerated except for side effects like mild dizziness and drowsiness. Conclusion: Gabapentin at 300mg orally three times daily has shown great promise in significantly reducing tamoxifen-induced hot flashes. Plans continue to complete the pilot study by enrolling 25 patients and proceed to randomized double blind placebo controlled trial.

Original languageEnglish
JournalBreast Cancer Research and Treatment
Volume69
Issue number3
StatePublished - Dec 1 2001
Externally publishedYes

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Hot Flashes
Tamoxifen
Breast Neoplasms
Quality of Life
gabapentin
Pharmaceutical Preparations
Monoamine Oxidase Inhibitors
Sleep Stages
Dizziness
Neurology
Antidepressive Agents
Progesterone
Heart Diseases
Neoplasms
Estrogens
Placebos

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Preliminary analysis of the pilot study using gabapentin on tamoxifen-induced hot flashes in women with breast cancer. / Thummala, A. R.; Griggs, J.; Rosenblatt, Joseph D; Sahasrabudhe, D.; Guttuso, T.; Morrow, G. R.; Pandya, K. J.

In: Breast Cancer Research and Treatment, Vol. 69, No. 3, 01.12.2001.

Research output: Contribution to journalArticle

Thummala, A. R. ; Griggs, J. ; Rosenblatt, Joseph D ; Sahasrabudhe, D. ; Guttuso, T. ; Morrow, G. R. ; Pandya, K. J. / Preliminary analysis of the pilot study using gabapentin on tamoxifen-induced hot flashes in women with breast cancer. In: Breast Cancer Research and Treatment. 2001 ; Vol. 69, No. 3.
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abstract = "Background: Hot Flashes are symptoms of vasomotor instability. They are reported in at least 50{\%}-57{\%} of women taking tamoxifen. No single agent has been shown to completely eliminate these distressing symptoms, thus the need exists to study newer agents. A clinically significant 94{\%} reduction in hoi flash frequency, in six menopausal women taking gabapentin for other reasons, was recently reported.(Guttuso, T. Neurology 54: 2161-2163, 2000). Anecdotal experience from six women with breast cancer treated with gabapentin 300mg orally three times daily reported marked reduction in hot flash frequency. Objective: To investigate the potential effect of oral gabapentin, for the control of tamoxifen-induced hot flashes in women with breasl cancer. Design: Open-label pilot study conducted at University of Rochester Cancer Center Oncology Program. Patients: 17 postmenopausal women with breast cancer on tamoxifen therapy and having at least one hot flash a day were enrolled on the study. Women on concurrent chemotherapy, uncontrolled hypertension, cardiac disease, hepatic dysfunction who require drugs like SSRIs, MAO inhibitors or other antidepressants were excluded from the study, intervention: Oral Gabapentin. 300 mg three times a day for four weeks. Measurements: In a daily diary, patients recorded number, duration, and severity of hot flashes and overall quality-of-life score (on a 10-point scale) during a 1-week baseline period and 1st and 4th weeks of treatment. Quality of life assessment was based on measures used by the post-menopausal estrogen/ progesterone intervention trial (PEPI). Results: A total of 14 patients completed the 4-week study. 3 women were taken off study due to side effects. Data collected on 12/14 women showed a mean decrease in hot flash duration of 66{\%} (p=. 085), frequency 38{\%} (p=. 001), and severity 47{\%} (p=. 000). Nine women reported 18{\%} improvement in quality of life (p=. 056). Three women had complete elimination of hot Hashes and continued on the drug post study. The drug was well tolerated except for side effects like mild dizziness and drowsiness. Conclusion: Gabapentin at 300mg orally three times daily has shown great promise in significantly reducing tamoxifen-induced hot flashes. Plans continue to complete the pilot study by enrolling 25 patients and proceed to randomized double blind placebo controlled trial.",
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AU - Griggs, J.

AU - Rosenblatt, Joseph D

AU - Sahasrabudhe, D.

AU - Guttuso, T.

AU - Morrow, G. R.

AU - Pandya, K. J.

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