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

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 Overview

• Status: Completed
• Conditions: Breast Cancer; Hot Flashes; Postmenopausal Symptoms
• Intervention / Treatment: Dietary supplement: non-estrogenic pollen extract PCC-100; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eline Meireson, Msc; Phone Number: 0032 9 332 78 17; Email: eline.meireson@uzgent.be

Study Locations

• Belgium
  • East Flanders
    • Gent, East Flanders, Belgium, 9000
      • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: non-estrogenic pollen extract PCC-100; 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.	Dietary supplement: non-estrogenic pollen extract PCC-100; non-estrogenic pollen extract PCC-100
Placebo Comparator: placebo; 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.	Other: placebo; placebo -non-estrogenic pollen extract PCC-100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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	6-8 weeks after randomisation and 12 weeks after randomisation

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Hot Flashes
• Other Study ID Numbers: EC/2017/1261

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No