Breast CancerNCT05098951
Acupuncture for Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer
A study testing Acupuncture in people with Breast Cancer and Stiffness of Hand, Not Elsewhere Classified, run by Affiliated Hospital of Qinghai University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Stiffness of Hand, Not Elsewhere Classified
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University
Xining, Qinghai, 810000
Dengfeng Ren, +8613086297659, dengfeng1104@126.com
About this study
Official title: Efficacy and Safety of Acupuncture for Relieving Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer
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.
Read the detailed description
Objectives of this study:
Primary objective:
To evaluate whether acupuncture as a non-pharmacological treatment, administered twice weekly for 6 weeks can significantly reduce joint stiffness related to AIs in women with early-stage breast cancer as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) stiffness score at weeks 6.
Secondary objectives:
To evaluate the effect of acupuncture on joint stiffness measured by the WOMAC stiffness score at weeks 12.
To evaluate the effect of acupuncture on joint stiffness measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) stiffness score at weeks 6 and weeks 12.
To evaluate the effects of acupuncture on quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) at weeks 6 and weeks 12.
To evaluate the safety and tolerability of acupuncture in the enrolled patients.
To identify potential genetic determinants to response to acupuncture.
- Being tested
- Acupuncture
- Keywords
- Breast cancer, Stiffness, Aromatase inhibitor, Acupuncture, High altitude
- Medical subject headings
- Breast Neoplasms, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) at the end of week 6 of intervention compared to that at baseline.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start20 Oct 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Qinghai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
- Investigators
- Jiuda Zhao, Principal investigator, the Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098951
- Sponsor's protocol ID
- AHQU-2021004
- Status last verified
- Nov 2021
- First submitted
- 17 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Acupuncture for Relieving Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT05098951
- Acronym / sponsor ID
- AHQU-2021004
- Keywords
- Breast cancer, Stiffness, Aromatase inhibitor, Acupuncture, High altitude
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Qinghai UniversityUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives of this study:
Primary objective:
To evaluate whether acupuncture as a non-pharmacological treatment, administered twice weekly for 6 weeks can significantly reduce joint stiffness related to AIs in women with early-stage breast cancer as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) stiffness score at weeks 6.
Secondary objectives:
To evaluate the effect of acupuncture on joint stiffness measured by the WOMAC stiffness score at weeks 12.
To evaluate the effect of acupuncture on joint stiffness measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) stiffness score at weeks 6 and weeks 12.
To evaluate the effects of acupuncture on quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) at weeks 6 and weeks 12.
To evaluate the safety and tolerability of acupuncture in the enrolled patients.
To identify potential genetic determinants to response to acupuncture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stiffness of joint receive acupuncture therapy | Experimental | Device: AcupunctureThis is a single arm study. All the enrolled patients will receive acupuncture twice weekly for 6 weeks then once weekly for another 6 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupuncturePatients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks. | Device | Patients with stiffness of joint receive acupuncture therapy |
Primary outcome
The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC)
Time frame: 6 weeks
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.
1 secondary outcome
The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiuda Zhao principal investigator
the Affiliated Hospital of Qinghai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Breast Cancer and Stiffness of Hand, Not Elsewhere Classified, run by Affiliated Hospital of Qinghai University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dengfeng Ren (+8613086297659, dengfeng1104@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.