Hot Water Therapy for Menopause-Related Hot Flashes

Overseen by Nathan Morris, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Colorado Springs

Disqualifiers: Cardiovascular illness

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 symptoms and improves mood in women who are undergoing or who have underwent menopause. It is hypothesized that women who undergo hot water therapy will have reduced hot flash symptoms and improved mood. Initial tracking period: Women who volunteer to participate in this study will be asked to track the frequency and intensity of their hot flash and other menopause-related symptoms for an initial two week period. Afterwards, they will start their heat therapy program. Physiological assessments: On days 1, 7, and 13 of the heat therapy sessions, the participants will enter a climate controlled room to have their thermoregulatory responses assessed. This will consist of slowly walking on a motorized treadmill in 99.5°F (37.5°C) and 30% relative humidity conditions, for 30 min, after which the humidity in the climate chamber will be progressively increased until their core temperature begins to increase (\~2 hour total time). Before and/or during these trials, core temperature, heart rate, whole-body sweat losses, thermal comfort, local sweat rate, and skin blood flow will be measured, and a 6 ml (\~1 tsp) blood sample will be taken, to assess how the participants respond to the heat stress. These sessions should take less than 3 hours to complete. Hot water therapy sessions: Upon enrolling in the study, the participants will be assigned to one of two groups: water bathing at 105°F or 97°F in the lab. On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves to a water level at the shoulders for \~30 min, followed by immersion to the hip level for \~60 min (total immersion time of 90 min). Post-intervention tracking period: after completing the heat therapy sessions, the participants will be asked to continue to take baths at home once every 4 days for 1 month. During this time, the participants will be asked to record the intensity and frequency of their hot flashes daily and other menopause-related symptoms weekly. At the end of this month the participants will be given a final exit survey, in order for them to provide the researchers information about their experience participating in the study.

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.

Is hot water therapy safe for humans?

Research on hyperthermia (heat therapy) for cancer treatment shows it is generally safe, with mild skin reactions being the most common side effect. However, more studies are needed to confirm its safety for other conditions. ^{1 2 3 4 5}

How is hot water therapy different from other treatments for menopause-related hot flashes?

Hot water therapy is unique because it uses warm water to alleviate hot flashes, which is a non-drug approach compared to hormone replacement therapy or medications. This method may appeal to those who prefer natural or alternative treatments and are uncomfortable with or ineligible for hormone-based therapies. ^{6 7 8 9 10}

Research Team

Nathan Morris, PhD

Principal Investigator

University of Colorado, Colorado Springs

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Hot Water Therapy (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Local Microwave Hyperthermia for Advanced or Recurrent Breast Cancer]. [2015]

2. England pubmed.ncbi.nlm.nih.gov

The tolerance of reirradiation and hyperthermia in breast cancer patients with reconstructions. [2012]

3. Singapore pubmed.ncbi.nlm.nih.gov

Principles, applications, risks and benefits of therapeutic hyperthermia. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Hyperthermia and radiation therapy for locally advanced or recurrent breast cancer. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Historical aspects of hyperthermia in cancer therapy. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for hot flashes: a randomized, sham-controlled clinical study. [2007]

8. Ireland pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for menopausal hot flashes: two case reports. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Health Characteristics Associated With Hot Flashes in Women With HIV During Menopause: An Integrative Review. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Hot flashes revisited: pharmacological and herbal options for hot flashes management. What does the evidence tell us? [2022]