Breast CancerNCT03684096
Effect of Non-estrogenic Pollen Extract PCC-100 on Hot Flushes
A study testing non-estrogenic pollen extract PCC-100 in people with Breast Cancer and Hot Flashes, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Hot Flashes, Postmenopausal Symptoms
- What is being tested?
- non-estrogenic pollen extract PCC-100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Oct 2018to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women, between 50 and 65 years old (extremes included) at the time of signing the informed consent form;
- spontaneous amenorrhea for at least 6 consecutive months in combination with a hormonal diagnosis of being postmenopausal (FSH > 40 mU/ml and E2 < 20 pg/ml. In subjects using Tamoxifen, only E2 needs to be determined) or spontaneous amenorrhea for at least 12 consecutive months or having had a bilateral oophorectomy at least 6 weeks prior to screening (with or without hysterectomy);
- a history of breast cancer, whatever the received treatment, and currently taking aromatase inhibitors or Tamoxifen since at least 4 weeks. This criterion is not applicable to the 100 subjects entering the study without a history of breast cancer;
- a minimum of 49 moderate to severe hot flushes or night sweats during 7 consecutive 24-h periods;
- a body mass index [BMI] between 18.0 and 35.0 kg/m2, inclusive;
- proven normal glycaemia and normal thyroid function as evidenced in a recent serum analysis (in the last year) performed by the General Practitioner or gynaecologist;
- The subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
Who cannot join
- Recently, an abnormal cervical Pap smear that requires surgery within 6 months;
- acute or chronic thromboembolic disease, liver disease and/or renal impairment;
- uncontrolled diabetes mellitus;
- uncontrolled hypertension;
- uncontrolled thyroid disorders;
- the subject has a history of a major depression or post-traumatic stress disorder [PTSD] within 2 years of screening. Women taking antidepressants can be included after a wash out period of 6 weeks;
Show all 10Show fewer
- use of (non-)hormonal treatments to reduce hot flushes, unless a wash-out period is respected;
- a history or presence of allergy or intolerance to the investigational product or any component of the investigational product or drugs in this class. Or history of drug or other allergy that, in the opinion of the investigator contraindicates subject participation;
- a history of alcohol or substance abuse or dependence in the 12 months before screening as determined by the investigator;
- judged by the investigator to be unsuitable for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Breast Cancer, Hot Flashes, Postmenopausal Symptoms
- Being tested
- non-estrogenic pollen extract PCC-100, placebo
- Medical subject headings
- Breast Neoplasms, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-estrogenic pollen extract PCC-100Dietary supplement
non-estrogenic pollen extract PCC-100
placeboOther
placebo -non-estrogenic pollen extract PCC-100
| Study group | Role | What they receive |
|---|---|---|
| non-estrogenic pollen extract PCC-100 | Active comparator | 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. Receives: Dietary Supplement: non-estrogenic pollen extract PCC-100 |
| placebo | Placebo comparator | 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily frequency of hot flashes
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
Measured: 12 weeks
Secondary outcomes (3)
Menopause symptoms
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).
Measured: 6-8 weeks after randomisation and 12 weeks after randomisation
Menopause symptoms
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.
Measured: 6-8 weeks after randomisation and 12 weeks after randomisation
Influence of hot flashes on daily life
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
Measured: 6-8 weeks after randomisation and 12 weeks after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start15 Oct 2018
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684096
- Sponsor's protocol ID
- EC/2017/1261
- Status last verified
- Feb 2024
- First submitted
- 21 Sep 2018
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03684096
- Acronym / sponsor ID
- EC/2017/1261
- Conditions
- Breast Cancer, Hot Flashes, Postmenopausal Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-estrogenic pollen extract PCC-100 | Active comparator | Dietary Supplement: non-estrogenic pollen extract PCC-100After 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. |
| placebo | Placebo comparator | Other: placeboAfter 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Postmenopausal women, between 50 and 65 years old (extremes included) at the time of signing the informed consent form;
- spontaneous amenorrhea for at least 6 consecutive months in combination with a hormonal diagnosis of being postmenopausal (FSH > 40 mU/ml and E2 < 20 pg/ml. In subjects using Tamoxifen, only E2 needs to be determined) or spontaneous amenorrhea for at least 12 consecutive months or having had a bilateral oophorectomy at least 6 weeks prior to screening (with or without hysterectomy);
- a history of breast cancer, whatever the received treatment, and currently taking aromatase inhibitors or Tamoxifen since at least 4 weeks. This criterion is not applicable to the 100 subjects entering the study without a history of breast cancer;
- a minimum of 49 moderate to severe hot flushes or night sweats during 7 consecutive 24-h periods;
- a body mass index [BMI] between 18.0 and 35.0 kg/m2, inclusive;
Key exclusion criteria (10 listed)
- Recently, an abnormal cervical Pap smear that requires surgery within 6 months;
- acute or chronic thromboembolic disease, liver disease and/or renal impairment;
- uncontrolled diabetes mellitus;
- uncontrolled hypertension;
- uncontrolled thyroid disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-estrogenic pollen extract PCC-100non-estrogenic pollen extract PCC-100 | Dietary supplement | non-estrogenic pollen extract PCC-100 |
| placeboplacebo -non-estrogenic pollen extract PCC-100 | Other | placebo |
Primary outcome
Daily frequency of hot flashes
Time frame: 12 weeks
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
3 secondary outcomes
Menopause symptoms
Time frame: 6-8 weeks after randomisation and 12 weeks after randomisation
Menopause symptoms
Time frame: 6-8 weeks after randomisation and 12 weeks after randomisation
Influence of hot flashes on daily life
Time frame: 6-8 weeks after randomisation and 12 weeks after randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-estrogenic pollen extract PCC-100 in people with Breast Cancer and Hot Flashes, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily frequency of hot flashes (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.