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| Sponsored by: |
Women and Infants Hospital of Rhode Island |
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| Information provided by: | Women and Infants Hospital of Rhode Island |
| ClinicalTrials.gov Identifier: | NCT00711529 |
Purpose
Premenopausal women with breast cancer who receive endocrine therapy (e.g. tamoxifen) and/or chemotherapy are at risk for experiencing premature menopause because of their treatment. The resulting symptoms, most notably hot flashes, can cause significant detriment to a patient's quality of life. Treatment for menopausal symptoms with the gold standard of hormone replacement therapy is not done routinely as it is unclear whether it can increase risk of tumor recurrence. In addition, many medical oncologists feel it is contraindicated in this population, especially among women whose breast cancers have estrogen receptors. This has lead to an increased interest in options other than estrogen replacement in the treatment of hot flashes, though most investigations of alternative medications have shown a suboptimal response.
Recent studies have suggested that non-drug treatments using alternative or complementary therapies may be effective. Specifically, hypnosis has been promoted as a means to control hot flashes, though it has not been tested in a randomized fashion. In accordance with the National Cancer Institute's recent initiatives to expand the goals of clinical trials to include symptom management studies, our purpose is to evaluate the role of complementary and alternative therapies for improvement of symptoms in women with breast cancer. Specifically, we plan to evaluate the use of hypnotherapy for the treatment of therapy-induced hot flashes in breast cancer survivors. We intend to recruit 60 women into a pilot feasibility trial comparing hypnotherapy to the drug gabapentin (Neurontin®) for the treatment of therapy-induced hot flashes in eligible women who are receiving care at the Breast Health Center. We have chosen gabapentin based on recent studies showing it may be an effective non-estrogen treatment for this indication.
We will identify patients who are experiencing at least one daily hot flash as a result of the treatment they received for their breast cancer for participation. When enrolled, they will be randomized into either the treatment arm, in which they will receive daily gabapentin, or the experimental arm, in which they will undergo weekly hypnotherapy.
Our study hypothesis is that hypnotherapy will be more effective than gabapentin in the control of hot flashes in this population.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Hot Flashes |
Behavioral: Hypnotherapy Drug: gabapentin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Comparison of Hypnotherapy Versus Gabapentin in the Treatment of Therapy-Induced Hot Flashes in Breast Cancer Survivors: a Pilot Study. |
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
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Behavioral: Hypnotherapy
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. surveys. The therapist will be prohibited from asking subjects about clinical responses to the hypnosis sessions. The patients will also be instructed on self-hypnosis techniques to be used at home.
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2: Active Comparator
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
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Drug: gabapentin
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily). This dose has been shown to be more effective than 300mg daily. Larger doses have not been evaluated in this population, and may be associated with a more significant side-effect profile. The prescription for gabapentin will be provided at the patient's enrollment appointment. The patients will take gabapentin as prescribed daily for the study-enrollment period, which is 8 weeks.
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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 has also been shown to improve outcomes in this population. However, it comes at the cost of vasomotor complaints that accompany menopause.
In fact, 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) may interfere with the metabolism of tamoxifen, a common treatment for estrogen-receptor positive breast cancers, by inhibiting the CYP2D6 enzyme. Gabapentin is a 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 inefficacy.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| Contact: Shannon D MacLaughlan, MD | 401-453-7520 | smaclaughlan@wihri.org |
| Contact: Don Dizon, MD | 401-453-7520 | ddizon@wihri.org |
| United States, Rhode Island | |
| Breast Health Center, Program in Women's Oncology, Women & Infants' Hospital of Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Shannon D MacLaughlan, MD 401-453-7520 smaclaughlan@wihri.org | |
| Contact: Don S Dizon, MD 401-453-7520 ddizon@wihri.org | |
| Sub-Investigator: Jennifer Gass, MD | |
| Sub-Investigator: Robert Legare, MD | |
| Sub-Investigator: Sandra Scuncio | |
| Sub-Investigator: Patrick Bowe | |
| Sub-Investigator: Sandra Salzillo-Shields | |
| Principal Investigator: | Shannon D MacLaughlan, MD | Women & Infants' Hospital of Rhode Island |
| Principal Investigator: | Don S Dizon, MD | Women & Infants' Hospital of Rhode Island |
More Information
| Responsible Party: | Women & Infants' Hospital of Rhode Island ( Don S. Dizon and Shannon D Maclaughlan, Principal Investigators ) |
| Study ID Numbers: | 08-0057 |
| Study First Received: | July 3, 2008 |
| Last Updated: | April 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00711529 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
hot flashes breast cancer Hypnotherapy Quality of Life Gabapentin |
|
Excitatory Amino Acids Neurotransmitter Agents Tranquilizing Agents Skin Diseases Gabapentin Psychotropic Drugs Hot Flashes Central Nervous System Depressants Breast Neoplasms Quality of Life |
Calcium Channel Blockers Cardiovascular Agents Antimanic Agents Signs and Symptoms Calcium, Dietary Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Breast Diseases Anticonvulsants |
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Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Hot Flashes Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Membrane Transport Modulators Signs and Symptoms Neoplasms by Site Sensory System Agents Therapeutic Uses |
Analgesics Breast Diseases Excitatory Amino Acid Antagonists Tranquilizing Agents Skin Diseases Breast Neoplasms Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Neoplasms Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |
