NCT05098951

Brief Summary

RATIONALE: Acupuncture may help relieve joint stiffness related to aromatase inhibitors in patients with early-stage breast cancer. PURPOSE: This single arm clinical study aims to evaluate how well acupuncture as a non-pharmacological treatment, works in treating patients with joint stiffness related to aromatase inhibitors (AIs) in patients with early-stage breast cancer.

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
52

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2021

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

October 17, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

October 17, 2021

Last Update Submit

November 9, 2021

Conditions

Breast CancerStiffness of Hand, Not Elsewhere Classified

Keywords

Breast cancerStiffnessAromatase inhibitorAcupunctureHigh altitude

Outcome Measures

Primary Outcomes (1)

  • The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC)

    The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) at the end of week 6 of intervention compared to that at baseline.

    6 weeks

Secondary Outcomes (1)

  • The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH)

    6 weeks

Study Arms (1)

Patients with stiffness of joint receive acupuncture therapy

EXPERIMENTAL

This is a single arm study. All the enrolled patients will receive acupuncture twice weekly for 6 weeks then once weekly for another 6 weeks.

Device: Acupuncture

Interventions

AcupunctureDEVICE

Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.

Patients with stiffness of joint receive acupuncture therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study just enroll female patients with breast cancer.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of stage I-III breast cancer and free of disease by clinical examination
  • Postmenopausal or premenopausal with ovarian suppression
  • Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) treatment
  • With joint stiffness attributed to the use of aromatase inhibitors
  • Having had joint stiffness for at least 1 months
  • Having had at least 15 days with stiffness in the preceding 30 days

You may not qualify if:

  • Women with recurrent or metastatic breast cancer
  • Women having finished chemotherapy or radiation therapy less than 1 months prior to enrollment
  • Women with history of bleeding disorder
  • Women with joint stiffness attributed to inflammatory arthritis, such as rheumatoid arthritis, spondy loarthritis and osteoarthritis
  • Women having joint stiffness prior to AI treatment
  • Women that have received treatment of any kind for joint stiffness within the last 3 months
  • Women that have previously received the acupuncture treatment before for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsAltitude Sickness

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Jiuda Zhao

    the Affiliated Hospital of Qinghai University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dengfeng Ren

CONTACT

+8613086297659dengfeng1104@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 17, 2021

First Posted

October 29, 2021

Study Start

October 20, 2021

Primary Completion

September 1, 2022

Study Completion

June 1, 2023

Last Updated

November 10, 2021

Record last verified: 2021-11

Locations

CN(1)