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Comparison of Hypnotherapy Versus Gabapentin in the Treatment of Hot Flashes in Breast Cancer Survivors or Women at Risk of Developing Breast Cancer.

Phase 3
18 Years
Not Enrolling
Breast Cancer, Hot Flashes

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Trial Information

Comparison of Hypnotherapy Versus Gabapentin in the Treatment of Hot Flashes in Breast Cancer Survivors or Women at Risk of Developing Breast Cancer.

Roughly half of women diagnosed with pre-menopausal breast cancer will have hormone
receptor-positive tumors, which will make them candidates for anti-estrogen therapies. Both
endocrine therapy and ovarian ablation have also been shown to improve outcomes in this

Hot flashes are a frequent side effect in women receiving anti-estrogen therapy for breast
cancer, and have been shown to have a significant impact on patients' quality of life. For
example, it has been reported that hot flashes in breast cancer survivors are more severe
and result in a more significant impact on quality of life measures when compared with
healthy women.

Hormone replacement, the gold standard for the treatment of hot flashes in postmenopausal
women, is contraindicated in this population. Non-hormonal drug therapies have been explored
for the treatment of hot flashes in this population of women with moderate results. In
randomized controlled trials, venlafaxine has been shown to reduce self-reported hot flashes
in patients with breast cancer by 25-61%. However, selective serotonin re-uptake inhibitors
(SSRIs) and selective norepinephrine re-uptake inhibitors (SNRIs) may interfere with the
metabolism of tamoxifen, a common treatment for estrogen-receptor positive breast cancers,
by inhibiting the cytochrome P450 2D6 (CYP2D6) enzyme. Gabapentin is a gamma-aminobutyric
acid (GABA) analogue commonly used for the treatment of seizure disorders and neuropathic
pain. There is some evidence to demonstrate its efficacy in hot flashes to be equivalent to
estrogen and superior to antidepressants in postmenopausal women.

In a pilot study of 22 women with breast cancer on tamoxifen, the use of gabapentin for four
weeks reduced the frequency of hot flashes by 44.2%, and decreased the hot flash severity
scores by 52.6%. These results were confirmed in a larger study of 420 breast cancer
survivors who were randomized to receive gabapentin 300mg/d, gabapentin 900mg/d, or placebo.
The 900mg/d dose of gabapentin was the most effective; decreasing the frequency of hot
flashes by 49% at four weeks. In the group receiving 900mg of gabapentin daily, there was a
12% withdrawal rate at 4 weeks, and 17% at 8 weeks, owing to side effects and subjective

Hypnosis or hypnotherapy, defined as the induction of a deeply relaxed condition that allows
the patient to suspend critical faculties and allow suggestibility, has been shown to be
effective in not only reducing the daily frequency of hot flashes (by 59%), but also in
improving quality of life variables such as insomnia in patients with breast cancer.
However, this therapy has never been compared directly to pharmacotherapy in the treatment
of therapy-induced hot flashes in patients with breast cancer.

In response to the NCI's 2006 initiatives to expand the goals of clinical trials and include
symptom management studies, we are interested in evaluating the role of complementary and
alternative therapies for improvement of symptoms in women with breast cancer. This trial is
to determine whether hypnotherapy, administered in a standard way, can improve the frequency
of hot flashes and breast cancer specific quality of life in women diagnosed with
pre-menopausal breast cancer. We propose to evaluate this through a pilot feasibility study
which will randomize participants to an eight week course of gabapentin or hypnosis.

Inclusion Criteria

Inclusion criteria:

- Women with histologic confirmation of a diagnosis of infiltrating carcinoma of the
breast are eligible for participation.

- Women with non-invasive or pre-invasive lesions of the breast, including but not
limited to ductal carcinoma in situ (DCIS), atypical ductal hyperplasia (ADH) or
lobular carcinoma in situ (LCIS) are eligible for participation.

- Women with a known breast cancer susceptibility gene (eg, BRCA) mutation or strong
family history of breast cancer are eligible.

- Any woman age 60 years or more who cannot take estrogen therapy because of a real or
perceived risk of developing breast cancer are eligible.

- Women under the age of 60 with a Gail model score of 1.6% or more are eligible.

- Subjective report of at least one daily hot flash.

- Able to provide voluntary informed consent.

- ≥ 18 years-old. There will be no upper limit for age inclusion.

- Karnofsky performance status > 70%.

- Women with a history of breast cancer must have undergone treatment with curative

- ≥ 4 weeks from completion of chemotherapy or radiation therapy, where appropriate.

- adequate hematopoietic function (ANC ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin
≥ 8 g/dL)

- adequate renal and hepatic function [Bilirubin ≤ 1.5 times upper limit of normal
(ULN), serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.5x ULN, Alkaline
phosphatase ≤ 2.5x ULN, and Creatinine ≤ 2x ULN].

- No clinical evidence of disease (complete remission).

- Patients receiving neoadjuvant therapy will be eligible following completion of all
adjuvant chemotherapy if indicated.

- Patients receiving hormonal therapy in lieu of or following chemotherapy will be
eligible to participate.

- Patients must have access to a compact disk player.

Exclusion criteria:

- History or active secondary cancer within the last 5 years (except for superficial
basal cell skin cancers).

- Any residual chemotherapy-induced CTCv3.0 Grade 2 or greater non-hematological

- Unable to give informed consent or unable to adhere to protocol.

- Any serious medical or psychiatric illness likely to interfere with participation in
this clinical study, concurrent uncontrolled illness, or ongoing or active infection
will be excluded.

- Any history of alcohol or drug abuse.

- Allergy to gabapentin.

- History of seizure disorder.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of Daily Hot Flashes

Outcome Description:

Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Shannon D MacLaughlan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Women & Infants' Hospital of Rhode Island


United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

June 2011

Related Keywords:

  • Breast Cancer
  • Hot Flashes
  • hot flashes
  • breast cancer
  • Hypnotherapy
  • Quality of Life
  • Gabapentin
  • Breast Neoplasms
  • Hot Flashes



Breast Health Center, Program in Women's Oncology, Women & Infants' Hospital of Rhode Island Providence, Rhode Island  02905