Breast CancerNCT05125432
Genetic Predictors to Acupuncture Response for Arthralgia Induced by Aromatase Inhibitors in Patients With Breast Cancer
A study testing Acupuncture group in people with Breast Cancer, run by Affiliated Hospital of Qinghai University at 1 site in China.
Trial summary
Purpose:Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer associated with screening of SNPs. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Acupuncture group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2021to 30 Nov 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;Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) treatment;
- AI-assisted treatment has lasted for more than one month, and there are obvious symptoms of arthralgia ;
- Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);
- Eastern Cooperative Oncology Group (ECOG) score of physical condition (0-1);
- Patients with previous local recurrence were eligible, but not patients with distant metastasis;
- The basic indexes were consistent, and the blood routine and ECG were normal.
Who cannot join
- Patients with needle phobia;
- Low platelet count (<50000); comorbidity with a bleeding disorder; comorbidity with thyroid dysfunction; pregnancy; haemoglobin levels <10 g/dl and haematocrit <30; anaemia on active pharmacological treatment orreceiving blood transfusion or steroids;
- Lymphoedematous of limbs;
- Patients have a history of acupuncture treatment for 6 months;
- Patients were reluctant to participate in the study;
- A prior history of inflammation, metabolic disease, or neurotic joints, except for previous treatment with bisphosphonates, steroids, or opioid analgesics.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Qinghai University
Xining, Qinghai, 810000
Jiuda Zhao, M.D., +8613327661976, jiudazhao@126.com
About this study
Purpose:Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer associated with screening of SNPs.
Read the detailed description
Aromatase inhibitor-induced arthralgia (AIA) is the most common side effect of aromatase inhibitors (AIs) used in breast cancer , may cause poor adherence to AIs. Studies have shown that acupuncture has a certain therapeutic effect on AIA in breast cancer. In this study, acupuncture was used to relieve the symptoms of arthralgia in patients, and the efficacy of acupuncture was observed by using relevant scales. Currently, studies have shown that AIA in breast cancer patients is related to some biological factors.
At the same time, we collected peripheral blood samples of patients, combined with the reported relevant literature, screened out the single nucleotide polymorphisms(SNP) related to AIA and to guide acupuncture treatment of aromatase Inhibitors induced arthralgia, balance the toxicity of endocrine therapy, and improve compliance and effectiveness.
- Conditions
- Breast Cancer
- Being tested
- Acupuncture group
- Keywords
- Single Nucleotide Polymorphisms, Breast Cancer, Aromatase Inhibitors, Arthralgia, Acupuncture
- Medical subject headings
- Breast Neoplasms, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture groupDevice
Acupuncture group Patients with breast cancer who experienced AIA were assessed by the Brief Pain Inventory (BPI)scale and McMasters College Osteoarthritis Index Score (WOMAC). Patients who met the criteria for inclusion would receive regular acupuncture treatment. The location of acupuncture is based on the principles of acupuncture treatment in Traditional Chinese medicine. Patients with high scores and obvious pain received standardized acupuncture treatment, and standard acupuncture points and most painful joint (up to 3) specific point. Meanwhile, blood samples of patients were collected, and SNP related to AIA was screened through SNP typing technology.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Acupuncture group Patients with breast cancer who experienced AIA were assessed by the Brief Pain Inventory (BPI)scale and McMasters College Osteoarthritis Index Score (WOMAC). Patients who met the criteria for inclusion would receive regular acupuncture treatment. The location of acupuncture is based on the principles of acupuncture treatment in Traditional Chinese medicine. Patients with high scores and obvious pain received standardized acupuncture treatment, and standard acupuncture points and most painful joint (up to 3) specific point. Meanwhile, blood samples of patients were collected, and SNP related to AIA was screened through SNP typing technology. Receives: Device: Acupuncture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in arthralgia scores were measured by the BPI
Changes in arthralgia scores were measured by the Brief Pain Inventory (BPI) before and after acupuncture treatment.
Measured: 52 weeks
Secondary outcomes (1)
Changes in arthralgia scores were measured by the WOMAC scales
Changes in arthralgia scores were measured by the McMasters College Osteoarthritis Index Score (WOMAC) scales before and after acupuncture treatment.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start25 Nov 2021 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125432
- Sponsor's protocol ID
- AHQU-2021006
- Status last verified
- Nov 2021
- First submitted
- 27 Sep 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Predictors to Acupuncture Response for Arthralgia Induced by Aromatase Inhibitors in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT05125432
- Acronym / sponsor ID
- AHQU-2021006
- Conditions
- Breast Cancer
- Keywords
- Single Nucleotide Polymorphisms, Breast Cancer, Aromatase Inhibitors, Arthralgia, Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Qinghai UniversityUniversity, hospital or other
- Study start
- 25 Nov 2021 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 18 Nov 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.
Purpose:Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer associated with screening of SNPs.
Detailed description
Aromatase inhibitor-induced arthralgia (AIA) is the most common side effect of aromatase inhibitors (AIs) used in breast cancer , may cause poor adherence to AIs. Studies have shown that acupuncture has a certain therapeutic effect on AIA in breast cancer. In this study, acupuncture was used to relieve the symptoms of arthralgia in patients, and the efficacy of acupuncture was observed by using relevant scales. Currently, studies have shown that AIA in breast cancer patients is related to some biological factors.
At the same time, we collected peripheral blood samples of patients, combined with the reported relevant literature, screened out the single nucleotide polymorphisms(SNP) related to AIA and to guide acupuncture treatment of aromatase Inhibitors induced arthralgia, balance the toxicity of endocrine therapy, and improve compliance and effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Device: Acupuncture groupAcupuncture group Patients with breast cancer who experienced AIA were assessed by the Brief Pain Inventory (BPI)scale and McMasters College Osteoarthritis Index Score (WOMAC). Patients who met the criteria for inclusion would receive regular acupuncture treatment. The location of acupuncture is based on the principles of acupuncture treatment in Traditional Chinese medicine. Patients with high scores and obvious pain received standardized acupuncture treatment, and standard acupuncture points and most painful joint (up to 3) specific point. Meanwhile, blood samples of patients were collected, and SNP related to AIA was screened through SNP typing technology. |
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;Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) treatment;
- AI-assisted treatment has lasted for more than one month, and there are obvious symptoms of arthralgia ;
- Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);
- Eastern Cooperative Oncology Group (ECOG) score of physical condition (0-1);
- Patients with previous local recurrence were eligible, but not patients with distant metastasis;
Key exclusion criteria (6 listed)
- Patients with needle phobia;
- Low platelet count (<50000); comorbidity with a bleeding disorder; comorbidity with thyroid dysfunction; pregnancy; haemoglobin levels <10 g/dl and haematocrit <30; anaemia on active pharmacological treatment orreceiving blood transfusion or steroids;
- Lymphoedematous of limbs;
- Patients have a history of acupuncture treatment for 6 months;
- Patients were reluctant to participate in the study;
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 |
|---|---|---|
| Acupuncture groupAcupuncture group Patients with breast cancer who experienced AIA were assessed by the Brief Pain Inventory (BPI)scale and McMasters College Osteoarthritis Index Score (WOMAC). Patients who met the criteria for inclusion would receive regular acupuncture treatment. The location of acupuncture is based on the principles of acupuncture treatment in Traditional Chinese medicine. Patients with high scores and obvious pain received standardized acupuncture treatment, and standard acupuncture points and most painful joint (up to 3) specific point. Meanwhile, blood samples of patients were collected, and SNP related to AIA was screened through SNP typing technology. | Device | Acupuncture group |
Primary outcome
Changes in arthralgia scores were measured by the BPI
Time frame: 52 weeks
Changes in arthralgia scores were measured by the Brief Pain Inventory (BPI) before and after acupuncture treatment.
1 secondary outcome
Changes in arthralgia scores were measured by the WOMAC scales
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No
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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.
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 group in people with Breast Cancer, 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 6 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 18 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in arthralgia scores were measured by the BPI (time frame: 52 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 18 Nov 2021.