Hot Water Therapy for Menopause-Related Hot Flashes

Overseen By Nathan Morris, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Colorado Springs

Disqualifiers: Cardiovascular illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 10 days

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether hot baths can reduce hot flashes and improve mood for women experiencing or who have experienced menopause. Participants will be divided into two groups: one taking baths at 105°F and another at 97°F. Women with menopause-related hot flashes may be suitable for this study. Researchers will track symptoms before and after the hot water therapy to determine its effectiveness. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance menopause symptom management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that hot water therapy is safe for menopause-related hot flashes?

Research shows that hot water therapy, such as taking hot baths, is usually safe and well-tolerated. Most people experience few serious issues. However, solid evidence on using hot water therapy specifically for menopause symptoms like hot flashes is limited.

The main risks of hot water therapy include dizziness or overheating. Dehydration can also occur if you don't drink enough water before or after the bath. These problems are usually mild and can be managed by drinking water and staying cool afterward. Always monitor how you feel and stop if you feel uncomfortable.

If you have any medical conditions that might be affected by heat, consult your doctor before trying hot water therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hot water therapy for menopause-related hot flashes because it offers a non-drug approach to managing symptoms. Unlike standard treatments like hormone replacement therapy or antidepressants, which can have side effects, hot water immersion is a natural method that involves immersing the body in water at specific temperatures. This technique could provide a soothing, alternative relief for women who prefer to avoid medication. Additionally, the use of controlled water temperature might target hot flashes more directly than current options, potentially offering a new avenue of comfort and symptom management.

What evidence suggests that hot water therapy might be an effective treatment for menopause-related hot flashes?

Research has shown that hot water therapy might help reduce hot flashes related to menopause. During menopause, the body often struggles to control temperature, causing hot flashes. Soaking in hot water may help the body manage these temperature changes better. Early studies suggest this could decrease the frequency and intensity of hot flashes. In this trial, participants will be assigned to different treatment arms, with some experiencing hot water immersion and others undergoing warm water immersion as a sham comparator. Although specific research on hot water therapy for menopause is limited, the idea is to help the body feel more comfortable with temperature changes. Overall, hot water therapy seems promising, but more research is needed to confirm its effectiveness. ^{1 2 4 6 7}

Who Is on the Research Team?

Nathan Morris, PhD

Principal Investigator

University of Colorado, Colorado Springs

Are You a Good Fit for This Trial?

This trial is for women experiencing menopause and suffering from hot flashes. Participants will track their symptoms, undergo heat therapy sessions in a lab, and continue baths at home. Women with certain health conditions that could be worsened by heat or who cannot commit to the study schedule may not qualify.

Inclusion Criteria

I experience hot flashes due to menopause.

Exclusion Criteria

I have a heart condition that prevents me from exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

Initial Tracking

Participants track the frequency and intensity of their hot flash and other menopause-related symptoms

2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline thermoregulatory assessments in a climate-controlled room

1 day

1 visit (in-person)

Treatment

Participants undergo hot water therapy sessions, with physiological assessments on specific days

10 days

Multiple visits (in-person)

Post-intervention Tracking

Participants continue hot baths at home and track symptoms, followed by an exit survey

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Hot Water Therapy

Trial Overview The study tests if hot water therapy can reduce hot flash symptoms and improve mood in menopausal women. It involves initial symptom tracking, controlled heat stress tests in a lab setting, followed by regular bathing sessions at two different temperatures.

How Is the Trial Designed?

Group I: Hot water immersion Experimental Treatment 1 Intervention

On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves up to the shoulder in 105°F water for \~30 min, followed by immersion to the hip level for \~60 min (total immersion time of 90 min).

Group II: Warm water immersion Placebo Group 1 Intervention

On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves up to the shoulder in 97°F water for \~30 min, followed by immersion to the hip level for \~60 min (total immersion time of 90 min).

Who Is Running the Clinical Trial?

University of Colorado, Colorado Springs

Lead Sponsor

Trials

20

Recruited

5,500+

East Carolina University

Collaborator

Trials

111

Recruited

42,400+

Published Research Related to This Trial

Women living with HIV experience more severe hot flashes during menopause compared to uninfected women, which can negatively impact their mood, sleep, and overall quality of life.

The review identified key health characteristics associated with hot flashes in this population, including HIV-specific factors, mental health issues, and social quality of life, highlighting the need for targeted research and clinical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Characteristics Associated With Hot Flashes in Women With HIV During Menopause: An Integrative Review. Rivard, C., Philpotts, LL., Flanagan, J., et al.[2019]

In a study involving 103 women experiencing hot flashes, medical acupuncture did not show a significant advantage over sham acupuncture in reducing the frequency of hot flashes after 5 weeks of treatment.

Both groups reported no adverse effects, indicating that acupuncture, whether medical or sham, is a safe option for women during menopause, but it may not be an effective treatment for hot flashes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for hot flashes: a randomized, sham-controlled clinical study. Vincent, A., Barton, DL., Mandrekar, JN., et al.[2007]

Progesterone may independently help relieve hot flashes, providing an alternative for women concerned about estrogen therapy.

New non-hormonal treatments like selective serotonin reuptake inhibitors (SSRIs) and the anti-convulsant gabapentin show promise in small studies, while other herbal remedies like black cohosh and vitamin E offer only modest and inconsistent benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hot flashes revisited: pharmacological and herbal options for hot flashes management. What does the evidence tell us? Haimov-Kochman, R., Hochner-Celnikier, D.[2022]

In a study involving 10 breast cancer patients, hyperthermia combined with chemotherapy (including AC, paclitaxel, S-1, and aromatase inhibitors) showed promising efficacy, with two patients experiencing a partial response to treatment.

The treatment was generally well-tolerated, with only mild toxicity observed (grade 1 acute skin toxicity), suggesting that hyperthermia could be a safe addition to breast cancer therapy, although further research with a larger patient group is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Local Microwave Hyperthermia for Advanced or Recurrent Breast Cancer]. Yamamoto, C., Yamamoto, D., Tsubota, Y., et al.[2015]

Two women undergoing individual cognitive behavioral treatment (CBT) for menopausal hot flashes reported significant reductions in the frequency of hot flashes and improvements in their quality of life, as measured by various scales.

These benefits were sustained for 6 months after the treatment ended, suggesting that CBT may effectively reduce hot flashes by addressing underlying stress and negative thought patterns, warranting further investigation in larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for menopausal hot flashes: two case reports. Allen, LA., Dobkin, RD., Boohar, EM., et al.[2018]

In a study of 36 breast cancer patients treated with reirradiation and hyperthermia, the treatment was found to be safe, with only a few cases of significant toxicity (grade 2 in 4 patients and grade 3 in 3 patients).

The combination of reirradiation and hyperthermia resulted in an 80% complete response rate for patients with macroscopic disease, and the 3 and 5 year local control rates were 74% and 69%, respectively, indicating effective treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The tolerance of reirradiation and hyperthermia in breast cancer patients with reconstructions. Linthorst, M., van Rhoon, GC., van Geel, AN., et al.[2012]

Hormone replacement therapy (HRT) is highly effective and should be the first treatment option discussed with all postmenopausal women experiencing hot flashes, due to its significant benefits.

For women who cannot or prefer not to use estrogen therapy, alternative treatment options should be considered to manage hot flashes that negatively impact their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hot flashes--physiology, hormonal therapy, and alternative therapies. Ginsburg, ES.[2013]

In a study of 127 patients with locally advanced or recurrent breast cancer, combined hyperthermia (HT) and radiation therapy (RT) resulted in over 50% of patients achieving local control of their disease, which is significant given the challenges of treating these cases with RT alone.

Higher doses of radiation and longer durations of hyperthermia (specifically, thermal equivalent doses of 42.5 °C for at least 200 minutes) were associated with improved overall survival and treatment response, highlighting the importance of these factors in the effectiveness of the combined treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperthermia and radiation therapy for locally advanced or recurrent breast cancer. Refaat, T., Sachdev, S., Sathiaseelan, V., et al.[2019]

Hyperthermia, once dismissed as a dubious cancer treatment, is gaining recognition as a potential fourth method of cancer therapy, supported by historical clinical discoveries and laboratory studies.

The American Cancer Society has shifted its stance on hyperthermia, removing it from its list of unproven therapies, indicating a growing acceptance of its potential role in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Historical aspects of hyperthermia in cancer therapy. Hornback, NB.[2004]

Hyperthermia, a heat therapy that raises body temperature, can be used alone or in combination with treatments like chemotherapy and radiotherapy to enhance therapeutic effects against cancer.

The paper reviews various heating methods and devices, highlighting the mechanisms of heat-induced cell death and discussing the benefits and risks associated with hyperthermia, as well as future research directions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles, applications, risks and benefits of therapeutic hyperthermia. Habash, RW., Krewski, D., Bansal, R., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06192329

Hot Water Therapy for the Treatment of Menopause-related ... The purpose of this research is to determine whether hot water therapy (i.e. taking prolonged hot baths on multiple consecutive days) decreases hot flash ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12051537/

Effects of menopause on temperature regulation - PMC Changes in thermoregulation, notably the emergence of hot flashes, occur during the menopause transition in association with reproductive hormonal changes.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/29/NCT06192329/ICF_000.pdf

Sample Informed Consent Format We expect that hot water therapy will reduce the intensity of these symptoms, particularly for those who experience hot flashes. If hot water therapy is found ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK285446/

Menopausal Symptoms: Comparative Effectiveness of Therapies Hormone and nonhormone therapies for menopausal symptoms may improve quality of life as well as reduce the occurrence or severity of the following symptoms.

5. yalemedicine.org yalemedicine.org/news/hot-flashes

Hot Flashes: How to Get Relief Before, During, and After ... Studies have shown that oral MHT is highly effective at alleviating hot flashes and night sweats. “However, the vaginal route of hormone ...

6. hopkinsmedicine.org hopkinsmedicine.org/health/conditions-and-diseases/introduction-to-menopause

Introduction to Menopause Hormone therapy has been shown to relieve some of the discomfort of hot flashes for many women. However, the decision to start using these hormones should be ...

7. cancer.org cancer.org/cancer/risk-prevention/medical-treatments/menopausal-hormone-replacement-therapy-and-cancer-risk.html

Menopausal Hormone Therapy and Cancer Risk Systemic hormones can help with certain symptoms of menopause, such as hot flashes and night sweats, as well as problems linked to thinning of ...