Clinical trial NCT03684096: Effect of Non-estrogenic Pollen Extract PCC-100 on Hot Flushes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Hot Flashes
Postmenopausal Symptoms
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 69
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Daily frequency of hot flashes
timeFrame: 12 weeks
Secondary outcomes:
measure: Menopause symptoms
timeFrame: 6-8 weeks after randomisation and 12 weeks after randomisation
measure: Menopause symptoms
timeFrame: 6-8 weeks after randomisation and 12 weeks after randomisation
measure: Influence of hot flashes on daily life
timeFrame: 6-8 weeks after randomisation and 12 weeks after randomisation
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
state: East Flanders
Study officials:
References: