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

Primary Purpose

Breast Cancer, Hot Flashes, Postmenopausal Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
non-estrogenic pollen extract PCC-100
placebo
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Ghent University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

non-estrogenic pollen extract PCC-100

placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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.
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

Full Information

First Posted
September 21, 2018
Last Updated
December 21, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03684096
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Hot Flashes, Postmenopausal Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
non-estrogenic pollen extract PCC-100
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
non-estrogenic pollen extract PCC-100
Intervention Description
non-estrogenic pollen extract PCC-100
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo -non-estrogenic pollen extract PCC-100
Primary Outcome Measure Information:
Title
Daily frequency of hot flashes
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Menopause symptoms
Description
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).
Time Frame
6-8 weeks after randomisation and 12 weeks after randomisation
Title
Menopause symptoms
Description
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.
Time Frame
6-8 weeks after randomisation and 12 weeks after randomisation
Title
Influence of hot flashes on daily life
Description
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
Time Frame
6-8 weeks after randomisation and 12 weeks after randomisation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
only women will be recruited
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eline Meireson, Msc
Phone
0032 9 332 78 17
Email
eline.meireson@uzgent.be
Facility Information:
Facility Name
Ghent University Hospital
City
Gent
State/Province
East Flanders
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eline Meireson
Phone
0032 9 332 78 17
Email
eline.meireson@uzgent.be

12. IPD Sharing Statement

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

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