Breast Cancer, Hot Flashes, Postmenopausal Symptoms
Conditions
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.
Interventions
DIETARY_SUPPLEMENTnon-estrogenic pollen extract PCC-100
non-estrogenic pollen extract PCC-100
OTHERplacebo
placebo -non-estrogenic pollen extract PCC-100
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily frequency of hot flashes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menopause symptoms | 6-8 weeks after randomisation and 12 weeks after randomisation | 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). |
| Influence of hot flashes on daily life | 6-8 weeks after randomisation and 12 weeks after randomisation | 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 |
Countries
Belgium
Outcome results
None listed