Treatment for Hot Flashes

1
Effectiveness
2
Safety
Northwestern University Feinberg School of Medicine, Chicago, IL
Hot Flashes+1 More
Eligibility
18+
Female
Eligible conditions
Hot Flashes

Study Summary

Stellate Ganglion Blockade in Post-Menopausal Women

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Eligible Conditions

  • Hot Flashes
  • Vasomotor Symptoms Associated With Menopause

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 8 secondary outcomes in patients with Hot Flashes. Measurement will happen over the course of Up to 12 weeks following intervention.

Week 12
Changes from baseline of Functional MRI
Week 4
Changes from baseline of Skin Sympathetic Nerve Activity (SKNA)
Month 6
Changes from baseline and intensity of subjective hot flashes (HF)
Changes from baseline of actigraph measures of sleep
Changes from baseline of frequency of objective hot flashes
Changes from baseline of scores of measures of sleep
Composite changes from baseline of scores of measures of mood
Composite changes from baseline of scores of measures of quality of life
Composite changes from baseline of scores of neurocognitive measures

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Bupivicaine
Placebo group

This trial requires 160 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Bupivicaine
Drug
Stellate Ganglion Block injection with bupivicaine
Saline
Drug
Saline injection

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 weeks (6 months) following intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 24 weeks (6 months) following intervention for reporting.

Closest Location

Northwestern University Feinberg School of Medicine - Chicago, IL

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Hot Flashes or the other condition listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A woman is defined as post-menopausal if she has not had a menstrual cycle in the past year, if her serum FSH levels are high (indicating a lack of estrogen production), or if she has undergone a bilateral oophorectomy (ovary removal surgery). show original
Between the ages of 40 and 70. show original
At least two weeks before the surgery, you will be asked to keep a record of your symptoms in a diary. show original
) Some women who have troublesome hot flashes that don't go away even after they take approved medicines to help (either hormone therapy or paroxetine) may need to try a different approach show original
The study found that there was no difference in the willingness to undergo fluoroscopy-guided SGB or sham treatment between the two groups. show original
for at least six consecutive months At least 50 people reported experiencing more than moderate-to-severe hot flashes per week for at least six consecutive months. show original
Within 30 days of the SGB intervention, safety labs will need to be established. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can hot flashes be cured?

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Hot flashes cannot be cured. Instead, medical specialists prescribe medications that reduce the frequency and severity of the common symptoms associated with hot flashes. Since most women who have symptoms of menopausal hot flashes do not have vasomotor symptoms for longer than 6 months, they are advised to initiate the most effective medications at the start of the menopausal transition (after breast cessation to prevent breast cancer) and continue taking those medications until symptomatic control is achieved.

Unverified Answer

What are the signs of hot flashes?

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Hot flashes are common symptoms that can affect an elderly woman's quality of life. Physicians should ask patients about the signs and symptoms of hot flashes and discuss ways to manage them.

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How many people get hot flashes a year in the United States?

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Between 2.3 and 3.0 million women annually in the USA report moderate to severe hot flashes requiring either medical treatment or a change in sexual activity.\n

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What are common treatments for hot flashes?

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Treatments for hot flashes vary by type. In almost every case, a hormone (e.g., oestrogen) is typically ineffective and can cause serious health side effects. Although not all women experience hot flashes, many treatments can have a high rate of success in treating the condition.

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What is hot flashes?

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Hot flashes are common events in menopause and women with prostate cancer. They are associated with a variety of physical and emotional symptoms. There is a need to create a more holistic approach to addressing problems associated with hot flashes in menopause.

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What causes hot flashes?

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hot flashes occur after any condition that question: What causes hot flashes? answer: Symptoms like excessive sweating or flushing may suggest hot flashes. Hot flashes are usually of the low-grade type and may occur after other conditions,

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What are the common side effects of treatment?

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Treatment with GnRH agonists and androscoginol has been described as being associated with nausea, vomiting, pain, breast tenderness, hot flashes, fatigue, hypoglycaemia, decreased libido, galactorrhoea, vaginal bleeding, amenorrhea, vaginal stenosis, increased urinary frequency, urinary incontinence, arthralgia and/or arthralgias, headache, loss of vision, eye pain, blurred vision, and in a few instances visual disturbances. The side effects experienced by patients have ranged widely in number and character from mild to severe.

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Does hot flashes run in families?

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The findings of this analysis strengthen the likelihood of familial heterogeneity for hot flashes, and may have an implication for genetic studies in this area.

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Who should consider clinical trials for hot flashes?

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Although most women with hot flashes felt that they needed clinical trials to relieve hot flashes and all felt that the information they obtained from a clinical trial would help them, many were unable to use clinical trial data to make an informed decision about the best short term treatment. Hot flashes were perceived as a personal problem rather than a medical issue and many women were unconcerned with any information about the risk and benefits of placebo. This suggests that clinical trials on hot flashes should be used not only to assess safety and evaluate medication efficacy, but also to improve women's satisfaction with information on which to make good decisions about their health care.

Unverified Answer

What is the average age someone gets hot flashes?

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Hot flashes normally happen at about 45 years old, but can happen at any age. While hot flashes can be disabling, they can happen with other menopausal symptoms as well. There is no “normal” average age of menopause.

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How does treatment work?

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Results from a recent clinical trial suggest that improvements in HRQL scores may improve sleep disturbances and QOL in patients with breast cancer undergoing antiestrogen therapy despite improvement in hot flashes or the presence of low-grade febrile neutropenia.

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What are the latest developments in treatment for therapeutic use?

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There is no evidence that newer agents and technology are effective. Most symptomatic care is for management to decrease pain symptoms, improving the patient experience. These treatments should be reassessed in randomized studies of the appropriateness of the management of the symptoms of the patient for these agents and the technology.

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See if you qualify for this trial
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