Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Flushing

Hot Flashes

Breast Diseases

Skin Diseases

Menopause

After randomisation patients will be devided in the group who will take the non-estrogenic pollen extract PCC-100 or the group who will receive placebo. The patients will take the drug or placebo for 12 weeks. During these 12 weeks the patients need to register the number and severity of the hot flashes. The patient will have 2 study visits during those 12 weeks.

non-estrogenic pollen extract PCC-100

placebo -non-estrogenic pollen extract PCC-100

placebo

Many postmenopausal women have vasomotor symptoms during adjuvant hormonal treatment for breast cancer. PCC-100 is a pollen extract used for alleviation of postmenopausal symptoms. In a randomised, double blinded study pollen extract PCC-100 will be used to treat vasomotor complaints in postmenopausal women under adjuvant hormonal treatment and also in menopausal women without a history of breast cancer.

Effect of Non-estrogenic Pollen Extract PCC-100 on Hot Flushes

The Effect of the Non-estrogenic Pollen Extract PCC-100 on Hot Flushes During Adjuvant Hormonal Treatment for Breast Cancer in Postmenopausal Women and in Menopausal Women Without a History of Breast Cancer

Daily frequency of hot flashes as mentioned in the daily diary the subjects need to complete during 12 weeks. The patient indicate in the diary the number, intensity (mild, moderate, severe) of hotflashes every day

Symptoms related to menopause will be asked to the patients by using the Menopause Rating Scale (MRS), this is a questionnaire with 11 questions about menopause and you can scale every question from 1 (no complaints) to 4 (severe).

Symptoms related to menopause will be asked to the patients by using the Green Climacteric Scale. This is a questionnaire of 21 questions about menopause. Every question can be scored from no complaints to very severe.

Influence of hot flashes on daily life will be asked by using a questionnaire: Hot-Flash Related daily interference scale. This 10-item scale measures a woman's perceptions of the degree to which hot flashes interfere with nine daily life activities; the tenth item measures interference with overall quality of life

University Hospital, Ghent

Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.

Self-administered white noise hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.

Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.

Self-Administered Hypnosis

Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.

Self-Administered White Noise Hypnosis

Gary Elkins, Ph.D.

Debra Barton, RN,PhD,FAAN

The long-term goal of this program of research is to determine safe and effective non-hormonal interventions for menopausal symptoms. The main goal of this study is to evaluate whether self-administered hypnosis can be used to significantly reduce hot flashes more than self-administered white noise hypnosis over 6 weeks of home practice. The investigators are also examining the impact of each hypnosis group on sleep, anxiety, perceived and measured stress, heart rate variability, and daily activities.

This randomized, two arm clinical trial will evaluate the efficacy of self-administered hypnosis for the treatment of hot flashes in postmenopausal women using a 1:1 randomization schedule.

Primary Objective

To evaluate the efficacy of the self-administered hypnosis intervention for hot flashes compared to the self-administered white noise hypnosis.

Hypothesis 1: Self-administered hypnosis will significantly decrease vasomotor symptoms (hot flash score of frequency and severity) compared to the self-administered white noise hypnosis at 6 weeks.

Secondary Objectives

To evaluate the efficacy of the self-administered hypnosis compared to self-administered white noise hypnosis for hot flash activity interference, sleep disturbance, anxiety and perception of benefit; with the expectation that there will be significant improvements among participants in the self-administered hypnosis group when compared with the self-administered white noise hypnosis group at 6 weeks. The investigators will also evaluate the effects of self-administered hypnosis compared to the self-administered white noise hypnosis at 12 weeks for all secondary outcomes except perception of benefit. Additionally, mediators (perceived stress, cortisol, and heart rate variability (HRV)) and moderators (hypnotizability and practice adherence) of hot flash reduction will be explored.

Hypothesis 2.1: Compared to self-administered white noise hypnosis, the self-administered hypnosis intervention will result in significant improvements in hot flash activity interference, sleep disturbance, and anxiety at 6 and 12 weeks, and perception of benefit at 6 weeks.

Hypothesis 2.2 A decrease in perceived stress will be indicated in the self-administered hypnosis group due to the intervention, which will correspond and contribute to further decrease of the hot flash score at 6 and 12 weeks.

Hypothesis 2.3 Diurnal salivary cortisol will demonstrate better circadian rhythms (steeper slopes) in those with larger hot flash reductions and in the self-administered hypnosis group compared to participants in the self-administered white noise hypnosis at 6 weeks.

Hypothesis 2.4 Self-administration of hypnosis and greater hot flash reductions will result in higher resting and 24-hour parasympathetic activity, reflected as higher HRV at 6 weeks.

Hypothesis 2.5 Higher hypnotizability scores and better adherence rates will be associated with greater reductions in hot flash scores in the self-administered hypnosis group.

Hypothesis 2.6 Self-administered hypnosis will significantly decrease vasomotor symptoms (hot flash score of frequency and severity) compared to the self-administered white noise hypnosis at 12 weeks.

Recruitment Plan

Potential participants will be identified in three ways: postcard mailings and invitation letters; physician referrals and IRB approved chart screening; and flyers, advertisements and press releases. Physician referrals will come primarily from cancer centers at University of Michigan Cancer Center Breast Clinic in Ann Arbor, MI, and the Baylor Scott \& White Health Center in Waco, TX.

At Michigan, key eligibility criteria will be used to identify potential eligible women through the Honest Broker Office. Charts will be further screened, with IRB approval, for eligibility. If eligible, women will be sent an invitation letter where they can opt in or out of being contacted to learn more about the study.

In addition, at Michigan, outreach will occur through obstetrics and gynecology, mammography, and internal medicine clinics to enable recruitment of women without a history of breast cancer. Mass mailings and local advertisement may also be used.

At Baylor University, a successful and proven method of accrual has been the use of mass mailings and local advertisement (e.g. newspaper, magazines, flyers). Additionally, Dr. Elkins is a medical associate with Baylor Scott \& White Health Center, which provides a direct connection with physicians and medical staff who will provide potential referrals.

It is expected that each site (Baylor University and University of Michigan) will recruit approximately half of the participants. Accrual will be closely monitored and efforts to randomize an equal number at each site will be made.

The study coordinators will provide education about the trial and a consent form for review both by phone and at the baseline/consent session. All other education beyond the baseline data collection will be provided at the second session 7-30 days later. Both sessions will be between 45-60 minutes. Sessions will be held at Dr. Barton's and Dr. Elkin's research offices, which each provide privacy, a recliner, a relaxing environment, and convenient parking.

Participants will be randomized and either be assigned to the self-hypnosis group or a self-administered white noise hypnosis group.

A Mind-Body Intervention for Hot Flash Management

Self-Administered Hypnosis Treatment for the Management of Hot Flashes in Women: A Randomized Clinical Trial

This is a 12-item research assistant administered scale for rating hypnotizability in the general population. The total scale ranges from 0-12. Each item is rated pass/fail, with higher scores indicative of greater hypnotizability. This scale has an excellent reliability with a Cronbach's alpha of .94.

A Hot Flash Daily Diary will be used to measure the primary outcome of hot flash score. Participants will be asked to complete the Hot Flash Daily Diary every day for 8 weeks total to measure the daily frequency and severity (mild, moderate, severe, and very severe) of their hot flashes. Each level of severity is given a value and participants will rate the severity of each hot flash as they experience it and record it in their daily diary. A total hot flash score will be calculated for each participant.

This is a 10-item scale that measures hot flash interference. The Hot Flash Related Daily Interference Scale asks respondents to rate the degree on a 0 (not at all) - 10 (very much so) scale that the hot flashes interfere with various daily activities as well as overall enjoyment or quality of life. The total score will range from 0-100. The higher the total score, the more likely hot flashes are interfering with the daily activities.This measure has been shown to be valid and internally consistent with Cronbach's alpha of .96.

This 29-item scale measures 5 domains of anxiety: 1) affective, 2)cognitive, 3) somatic, 4) behavioral, and 5) need for treatment. Items are scored on a scale from 1 (never) - 5 (always) with higher scores reflecting more severe anxiety. The total range for this scale is 0-145. This scale has shown excellent convergent and discriminate validity with other measures with a Cronbach's alpha .95.

This is a 19-item self-report inventory designed to measure sleep disturbance. The 19 items are grouped into 7 sub-scales: 1) sleep quality; 2) sleep efficiency; 3) daytime dysfunction; 4) sleep latency; 5) sleep disturbances; 6) sleep duration; and 7) use of sleep medication.These seven sub-scales are scored on a scale of 0 (better) - 3 (worse) with higher scores indicating greater sleep pathology. The sub-scales are then added for a combined total score ranging from 0 (better) - 21 (worse). Alphas for the Pittsburgh Sleep Quality Index range from .70 to .80.

This is a 7-point item in which participants rate the change in hot flashes since beginning the study (ranging from 'very much better', 'moderately better', 'a little better', 'about the same', 'a little worse', 'moderately worse', to 'very much worse'). It has been used extensively for determination of minimally clinically significant differences in numerous oncology clinical trials.Four additional investigator-developed questions about satisfaction are included as well as two questions about the use of the audio recordings.

Saliva will be collected three times a day over two consecutive days at two time points during the study. Participants will be provided specific directions for the collection of saliva upon awakening (before getting out of bed), 30 minutes later (before eating, drinking, or tooth brushing), and finally at bedtime (around 10 pm, also before tooth brushing) and will be given a Saliva Collection Diary with questions to answer about their saliva collection. This procedure is well-established and considered valid for the measurement of diurnal cortisol rhythm.

The shift in autonomic balance from sympathetic dominance (stress response) to parasympathetic dominance (relaxation response) is a very likely candidate for the underlying mechanism of the effects of mind-body interventions on vasomotor symptoms. Relatedly, an increasing body of evidence indicates that hot flash events are associated with changes in heart rate variability.

The Polar V800, a mobile HRV recording device, will be worn to collect data over a 24-hour natural ambulatory period as well as two supine standardized 6-minute recording during the two days of cortisol collection. The 24hr and 6 min measurements will be completed (each on separate days) at pre and post-trial.

This is a 10-item scale that measures the degree to which situations in one's life are appraised as stressful. The scale provides the degree to which individuals find their lives to be unpredictable, uncontrollable, and overloaded, as well as measures the current levels of experienced stress. Items are scored on a scale from 0 (never) - 4(very often) for a total score ranging from 0-40. with higher scores reflecting more perceived stress. This measure has been shown to be valid and internally consistent, with an alpha of .83.

Participants in both groups will be given a log that will be completed daily. The log will provide space to put the date, whether or not the participant listened to their audio recording, the number of times they practiced (with or without the audio recordings), and provide a space for comments about any interruptions or barriers to listening to their assigned recording.

National Center for Complementary and Integrative Health (NCCIH)

University of Michigan

Baylor University

Director of Mind-Body Medicine Research Lab

Atrophy

All Drugs and Chemicals

Gastrointestinal Agents

Bone Density Conservation Agents

Herbal and Botanical

Other Dietary Supplements

Aromatase Inhibitors

Psyllium

Calcium polycarbophil

Dehydroepiandrosterone

Calcium

Calcium, Dietary

Adjuvants, Immunologic

Immunologic Factors

Loperamide

Antidiarrheals

Laxatives

Cathartics

DHEA (Dehydroepiandrosterone)

Vaginal insert with 6.5 mg vaginal DHEA self-administered once daily at bedtime for 12 weeks

Prefilled vaginal applicator with 2.5 g of polycarbophil vaginal moisturizing gel, self-administered two times per week at night for 12 weeks

This is a vaginally administered suppository steroid indicated for the treatment of moderate to severe dyspareunia, a frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause.

Vaginal Dehydroepiandrosterone

This is an FDA cleared, over-the-counter personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. It is non-sterile, water-based, non-irritating, non-greasy, non-staining vaginal gel delivered as a long-lasting moisturizer for vaginal dryness.

Vaginal Polycarbophil Moisturizer

Gloria Richard-Davis, MD

The purpose of this research is to gather information on the safety and effectiveness of Intrarosa®, also known as Dehydroepiandrosterone (DHEA), and prasterone. By doing this study, the investigators hope to learn if Intrarosa® can improve vaginal discomfort. Participants will be assigned to one of two groups. One group will use Intrarosa® once a day. The other group will use Replens™ two times a week.

This will be a two-armed, randomized Phase II trial. All study subjects will be asked to fill out a simple 5-question sexual functioning survey. If any concern about sexual functioning is noted, the subject will also be asked to fill out a more extensive Sexual functioning tool, to help determine which domain of sexual functioning is the most bothersome.

Subjects who complete the initial screening will be randomly assigned to the Intrarosa® or Replens™ arm by a 1:1 ratio. Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week). Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks.

At baseline and at 12 weeks, subjects will undergo a physical exam including clinical breast and gynecological exam. During gynecologic exams, the vaginal Potential of Hydrogen (pH) will be determined and a swab of vaginal epithelium sent for determination of the Vaginal Maturation Index (VMI) and Maturation Value (MV). These will be used as objective physiologic markers to determine the improvement in vaginal atrophy. The cytologist's reading specimens will be blinded.

Additionally, all study subjects will be asked to fill out questionnaires at baseline and again in 12 weeks.

Subjects are randomly assigned to the Intrarosa® or Replens™ arm by a 1:1 ratio. Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week). Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks.

The cytologist's reading specimens will be blinded.

Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors

Comparison of Vaginal Dehydroepiandrosterone (DHEA) to Control for Treatment of Vaginal Symptoms in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors: A Phase II Randomized Trial

Improvement of the vaginal maturation index (VMI) calculated based on the decrease of the percentage of the parabasal cells and the increase of the sum of the percentages of the intermediate and superficial cells

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Non-estrogenic Pollen Extract PCC-100 on Hot Flushes	NCT03684096	Breast Cancer Hot Flashes Postmenopausal ...	non-estrogenic ... placebo	50 Years - 65 Years	University Hospital, Ghent
A Mind-Body Intervention for Hot Flash Management	NCT03572153	Hot Flashes Postmenopausal ... Breast Cancer	Self-Administer... Self-Administer...	18 Years -	Baylor University
Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors	NCT04493333	Vaginal Atrophy Postmenopausal ... Breast Cancer F... Long-term Survi...	Vaginal Dehydro... Vaginal Polycar...	18 Years - 70 Years	University of Arkansas
Effect of Non-estrogenic Pollen Extract PCC-100 on Hot Flushes	NCT03684096	Breast Cancer Hot Flashes Postmenopausal ...	non-estrogenic ... placebo	50 Years - 65 Years	University Hospital, Ghent
Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors	NCT04493333	Vaginal Atrophy Postmenopausal ... Breast Cancer F... Long-term Survi...	Vaginal Dehydro... Vaginal Polycar...	18 Years - 70 Years	University of Arkansas

Spots Global Cancer Trial Database for postmenopausal symptoms