NCT03540251

Brief Summary

Object:The aim of this study was to investigate the effectiveness of sticking and massaging auricular points for the management of hot flashes in postoperative breast cancer patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

January 4, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

February 10, 2018

Last Update Submit

March 3, 2019

Conditions

Breast CancerHormonal TherapyHot FlashesAcupuncture

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Hot Flash Score at 12 weeks

    Each week's average HFS of both treatment and placebo group was recorded and all the findings were statistically treated by General Estimation Equation(GEE) .

    "an average of 1 year" Collect all cases and fill in CRFs;"up to 24 weeks"log in data and complete statistics;"up to 24 weeks"refine the paper and publish articles

Secondary Outcomes (2)

  • Change from Baseline GCS and MenQoL at 12 weeks

    "an average of 1 year" Collect all cases and fill in CRFs;"up to 24 weeks"log in data and complete statistics;"up to 24 weeks"refine the paper and publish articles

  • Change from Baseline beta-EP at 12 weeks

    "an average of 1 year" Collect all cases and fill in CRFs;"up to 24 weeks"log in data and complete statistics;"up to 24 weeks"refine the paper and publish articles

Other Outcomes (1)

  • Safety and Tolerability-treatment-related adverse events

    "an average of 1 year" Collect all cases and fill in CRFs;"up to 24 weeks"log in data and complete statistics;"up to 24 weeks"refine the paper and publish articles

Study Arms (2)

Therapeutic auricular points treatment

ACTIVE COMPARATOR

Therapeutic auricular points treatment including auricular points:CO18、TF2、TF4、AT4、CO15（with complaint of sweating）or CO12(with symptom of heart palpitation)in accordance with the position of auricular points Location map of national standard(GBVT13734-2008) Both groups received a booklet with information about self-care indications, auricular points and its management, and patients can record their hot flash score each day for 12 weeks in the booklets. In addition, both group received 8 treatment sessions of sticking and pressing predefined auricular points.

Other: Auricular Points Sticking

Placebo auricular points treatment

SHAM COMPARATOR

Placebo auricular points treatment including auricular points AH9、AH11、TG3、AT2、LO4 in accordance with the position of auricular points Location map of national standard(GBVT13734-2008) Both groups received a booklet with information about self-care indications, auricular points and its management, and patients can record their hot flash score each day for 12 weeks in the booklets.In addition, both group received 8 treatment sessions of sticking and pressing placebo auricular points treatments.

Other: Auricular Points Sticking

Interventions

Auricular Points StickingOTHER

Auricular Points Sticking is a kind of acupunture based on Meridians Theory of traditional Chinese Medicine.Sticking and pressing predefined therapeutic auricular points can relieve the frequency and severity of hot flashes and other climacteric symptoms. Both groups received a booklet with information about self-care indications, auricular points and its management, and patients can record their hot flash score each day for 12 weeks in the booklets.In addition, both group received 8 treatment sessions of sticking and pressing predefined auricular points or placebo auricular points treatments.

Placebo auricular points treatmentTherapeutic auricular points treatment

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostoperative breast cancer patients who are receiving who hormonal therapy
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primary breast cancer after surgical treatment, pathologically diagnosed malignant breast epithelial tumors (breast cancer), immunohistochemistry showed pathological type of estrogen receptor (ER) and / or progesterone receptor (PR) positive.
  • Participants should be currently receiving endocrine therapy with oral administration of SERMS(selective estrogen receptor modulators) only.
  • Participants should be suffered from perimenopausal symptoms,which is the sudden onset of facial skin flushing, sweating, began from chest and neck,often lasts a few seconds to several minutes and then subsided after center body temperature drops, the associated symptoms of heart palpitations, anxiety, impatience and even a sense of panic, and even wake up at night. The interval between the two attacks is more than 10 minutes.
  • Hot flashes occurs during endocrine therapy of breast cancer
  • KPS score \>60 score \>2 and ECOG
  • Hot flashes (greater than or equal to 3 times the number of hot flashes per day)
  • Symptoms persist for more than 2 weeks

You may not qualify if:

  • Participants who have uncontrolled diabetes, hyperthyroidism and hypertension and in patients with pheochromocytoma
  • Abnormal blood routine, liver and kidney damage (the index is greater than 1.2 times the upper limit of normal value)
  • Pregnant or lactating women, persons with mental disorders
  • Participants with other cancers
  • Participants are participating in other clinical trials
  • Current chemotherapy treatment period has not yet completed
  • Taking corticosteroids or sex hormone treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua Hosptial

Shanghai, Shanghai Municipality, 021, China

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsHot Flashes

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sheng Liu, Doctor

    Shanghai University of Traditional Chinese Medincine Afflicated Longhua Hospital

    STUDY DIRECTOR

Central Study Contacts

Sheng Liu, Doctor

CONTACT

18917763005lshtcm@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 10, 2018

First Posted

May 30, 2018

Study Start

January 4, 2019

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations

CN(1)