An interventional study of Manual Acupuncture in Aromatase Inhibitor-Associated Musculoskeletal Syndrome, Arthralgia Syndrome and Early Breast Cancer (EBC), sponsored by Masaryk Memorial Cancer Institute. Active, not recruiting at 1 site in Czechia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Masaryk Memorial Cancer Institute · Not applicable, Interventional, and Supportive care
Third-generation aromatase inhibitors (AIs) represent a standard adjuvant endocrine treatment for postmenopausal and high-risk premenopausal women with hormone receptor-positive early breast cancer. However, aromatase inhibitor-associated musculoskeletal syndrome (AIMSS)-characterized by joint pain, stiffness, and reduced mobility-occurs in approximately 50% of patients and significantly impairs treatment adherence and patient quality of life. Poor adherence to endocrine therapy is associated with reduced overall survival.
The purpose of this prospective, randomized (1:1), open-label, parallel-group clinical trial is to evaluate the efficacy, safety, and duration of therapeutic relief of acupuncture in managing AI-induced musculoskeletal symptoms in female patients with early-stage breast cance. A total of 200 participants experiencing AI-related joint pain are randomized either to receive 10 weekly 20-minute sessions of manual acupuncture over 10 weeks or to a control group receiving standard care without acupuncture. Joint pain severity, upper limb muscle strength and dexterity, sleep quality, and psychological distress are evaluated using validated patient-reported outcomes (Brief Pain Inventory [BPI], Rheumatoid Arthritis Pain Scale [RAPS], Pittsburgh Sleep Quality Index [PSQI], and Hospital Anxiety and Depression Scale [HADS]) as well as objective physical performance tests (Hand Grip Strength Test and Grip Ability Test) at baseline, 10 weeks, 14 weeks (4 weeks post-intervention), and 22 weeks (3 months post-intervention).
Background and Rationale: Adjuvant endocrine therapy with third-generation aromatase inhibitors (AIs; anastrozole, letrozole, or exemestane) significantly improves disease-free and overall survival in hormone receptor-positive early breast cancer. However, aromatase inhibitor-associated musculoskeletal syndrome (AIMSS) develops in approximately 50% of treated patients, presenting as joint pain (arthralgia), morning stiffness, and restricted mobility, predominantly affecting the small joints of the hands and wrists. AIMSS is a leading cause of non-adherence or early treatment discontinuation, which has been directly correlated with reduced long-term overall survival. Standard management options (oral non-steroidal anti-inflammatory drugs, exercise) offer limited efficacy, and long-term use of systemic analgesics entails significant side effects. Manual acupuncture is a recommended non-pharmacological supportive care option (e.g., within NCCN guidelines), yet available clinical evidence remains limited by small sample sizes and methodological variability.
Study Design and Interventions: This is a prospective, randomized (1:1), open-label, parallel-group clinical trial enrolling 200 female patients experiencing AIMSS. Participants are stratified at baseline according to age (≤ 50, 51-64, > 65 years), ECOG performance status (0 vs. 1-2), and baseline Brief Pain Inventory (BPI) pain score (4-6 vs. 7-10).
Experimental Group (Arm I, n = 100): Participants undergo 10 weekly 20-minute sessions of manual acupuncture over a 10-week intervention period. Acupuncture is administered by trained, licensed physicians according to STRICTA guidelines using sterile, single-use ENERGY Wuxi Jiajian needles (25×0.25 mm, 40×0.25 mm, 40×0.20 mm) inserted at traditional depths. Mandatory bilateral needle stimulation is performed at 4 core points: GB41, GB34, TE5, and LI4 (8 needles total). Additional optional points (e.g., ST36, BL60, KI3, PC6, CV6) may be selected based on individual clinical presentation and are systematically logged.
Control Group (Arm II, n = 100): Participants receive standard care without acupuncture and undergo functional testing and questionnaire completion on the exact same schedule as Arm I.
Visit Schedule and Patient Evaluations: Total participant involvement lasts 22 weeks across 4 primary evaluation milestones:
Baseline (Week 1 / Visit 1): Screening of inclusion/exclusion criteria, written informed consent, demographic data collection, baseline BPI pain assessment (threshold score ≥ 4 required), baseline patient-reported outcome questionnaires (RAPS, PSQI, HADS, HAQ), and objective upper-limb physical testing (Hand Grip Strength Test and Grip Ability Test).
Week 10 (Visit 10 for Arm I / Visit 2 for Arm II - End of Intervention): Primary assessment of pain reduction, muscle strength, dexterity, sleep quality, and psychological distress.
Week 14 (Visit 11 for Arm I / Visit 3 for Arm II - 4 Weeks Post-Intervention): Evaluation of early persistence of therapeutic relief and functional outcomes.
Week 22 (Visit 12 for Arm I / Visit 4 for Arm II - 3 Months Post-Intervention): Final study evaluation assessing long-term maintenance of treatment effect and study completion.
Safety Monitoring and Data Management: Adverse events associated with acupuncture (e.g., localized bleeding, infection, vasovagal collapse, periosteal/nerve irritation, fatigue, or temporary symptom exacerbation) are monitored at each treatment visit and at final follow-up. All clinical data are recorded in a validated electronic Case Report Form (eCRF) hosted on secure servers maintained by the CZECRIN research infrastructure, adhering to Good Clinical Practice (GCP) and GDPR guidelines.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 200 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Masaryk Memorial Cancer Institute is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo 10 weekly 20-minute sessions of manual acupuncture over a 10-week period. Sterile, single-use ENERGY Wuxi Jiajian needles (25×0.25 mm, 40×0.25 mm, 40×0.20 mm) are applied at traditional depths. Mandatory bilateral needle stimulation is performed at four core points: GB41, GB34, TE5, and LI4 (8 needles total). Additional points (such as ST36, BL60, KI3, PC6, and CV6) may be selected and documented based on individual clinical presentation. Participants complete patient-reported outcome questionnaires (BPI, RAPS, PSQI, HADS, and HAQ) and undergo physical testing for hand grip strength and finger dexterity (Hand Grip Strength Test and Grip Ability Test) at Baseline (Week 1), Week 10, Week 14, and Week 22 (3 months post-intervention), across a total of 12 study visits.
Device: Manual Acupuncture
Participants receive standard care without acupuncture intervention. Participants complete the identical battery of questionnaires (BPI, RAPS, PSQI, HADS, and HAQ) and undergo objective functional testing for hand grip strength and finger dexterity at the exact same time points as Arm I (Baseline, Week 10, Week 14, and Week 22). Total participation for Arm II comprises 5 study visits.
Participants undergo 10 weekly sessions of manual acupuncture lasting 20 minutes per session over a total period of 10 weeks. Acupuncture is administered by trained physicians in accordance with STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture) guidelines. Sterile, single-use ENERGY Wuxi Jiajian acupuncture needles (dimensions: 25×0.25 mm, 40×0.25 mm, 40×0.20 mm) are applied at traditional depths. Each session requires mandatory bilateral stimulation of four core acupuncture points: GB41, GB34, TE5, and LI4 (8 needles total). Additional points (such as ST36, BL60, KI3, PC6, CV6, or other points) may be selected based on the participant's individual clinical presentation and are systematically recorded.
Change from Baseline in Musculoskeletal Pain Severity Score as Assessed by the Brief Pain Inventory Short Form (BPI-SF)
Musculoskeletal pain severity is evaluated using the Brief Pain Inventory Short Form (BPI-SF) pain severity score, calculated as the arithmetic mean of items 3 through 6 (worst pain, least pain, average pain, and pain right now in the last 24 hours). The pain severity score ranges from 0 to 10, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine." Higher scores indicate greater pain severity (worse outcome). Change is calculated as the post-baseline score minus the baseline score.
Time frame: Baseline, Week 10, Week 14, and Week 22.
Change from Baseline in Upper Limb Muscle Strength as Assessed by the Hand Grip Strength Test (HGS)
Upper limb muscle strength will be objectively evaluated using the Hand Grip Strength Test (HGS). Muscle strength is measured in kilograms (kg) and calculated as the arithmetic mean of 3 consecutive measurements on the dominant/tested arm. Higher values indicate greater muscle strength (better outcome). Change is calculated as post-baseline value minus baseline value.
Time frame: Baseline (Week 1), Week 10, Week 14, and Week 22.
Change from Baseline in Musculoskeletal Pain Severity Score as Assessed by the Rheumatoid Arthritis Pain Scale (RAPS)
Musculoskeletal pain severity is evaluated using the Rheumatoid Arthritis Pain Scale (RAPS) questionnaire, a 24-item self-report questionnaire assessing pain across physiological, affective, sensory, and cognitive dimensions. Each item is scored on a 0 to 6 scale (0 = Never, 6 = Always), yielding a total score ranging from 0 to 144. Higher scores indicate greater pain severity and pain impact (worse outcome). Change is calculated as the post-baseline score minus the baseline score.
Time frame: Baseline, Week 10, Week 14, and Week 22.
Change from Baseline in Finger Dexterity and Hand Function as Assessed by the Grip Ability Test (GAT)
Finger dexterity and upper limb coordination will be objectively evaluated using the Grip Ability Test (GAT). The test measures the time required in seconds to complete standard functional hand tasks (such as putting a Tubigrip sock on a item, attaching a paperclip to an envelope, and pouring water from a pitcher). Lower values (shorter time in seconds) indicate better dexterity and hand function (better outcome). Change is calculated as post-baseline value minus baseline value.
Time frame: Baseline (Week 1), Week 10, Week 14, and Week 22.
Change from Baseline in Anxiety Score as Assessed by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Psychological anxiety will be evaluated using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The subscale consists of 7 items scored on a 4-point Likert scale (0 to 3), yielding a total score ranging from 0 to 21. Higher scores indicate greater anxiety severity (worse outcome). Change is calculated as post-baseline score minus baseline score.
Time frame: Baseline (Week 1), Week 10 (end of 10-week intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention).
Change from Baseline in Overall Sleep Quality Score as Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Sleep quality and sleep disturbances will be evaluated using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. The PSQI assesses sleep quality over a 1-month time interval through 19 individual items grouped into 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction). Each component is scored from 0 to 3, yielding a total Global PSQI Score ranging from 0 to 21. Higher scores indicate poorer sleep quality and greater sleep disturbance (worse outcome). Change is calculated as the post-baseline score minus the baseline score.
Time frame: Baseline (Week 1), Week 10 (end of intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention).
Durability and Duration of Pain Relief Post-Intervention as Assessed by Brief Pain Inventory Short Form (BPI-SF)
Evaluates the persistence and duration of therapeutic pain relief following the completion of the 10-week intervention. Pain severity is assessed using the Brief Pain Inventory Short Form (BPI-SF) pain severity score (range 0 to 10, where higher scores indicate worse pain) across post-intervention follow-up visits (Week 14 and Week 22) compared to Week 10 to determine the maintenance of pain reduction over time.
Time frame: Baseline (Week 1), Week 10 (end of intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention).
Number of Participants With Treatment-Related Adverse Events
Safety and tolerability of the acupuncture intervention will be evaluated by monitoring the incidence, type, severity, and potential causality of adverse events. Tracked events include localized bleeding, site infection, vasovagal collapse, nerve or periosteal irritation, increased fatigue, and transient symptom exacerbation. The outcome will report the number of participants experiencing one or more treatment-related adverse events.
Time frame: Continuously at each treatment session (Weeks 1 through 10) and at the final follow-up visit at Week 22.
Change from Baseline in Depression Score as Assessed by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
Psychological depression and mood will be evaluated using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The subscale consists of 7 items scored on a 4-point Likert scale (0 to 3), yielding a total score ranging from 0 to 21. Higher scores indicate greater depression severity (worse outcome). Change is calculated as post-baseline score minus baseline score.
Time frame: Baseline (Week 1), Week 10 (end of 10-week intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention).
Plan to share: Yes — IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.
Supporting information: Clinical study report
Time frame: after study completion
Access criteria: During the study, data will be managed in pseudonymized form in a protected database environment, available only for study team. After completion of the study, the data will be fully anonymized for publication purposes. All publication outputs of the study will be carried out by a team of researchers led by the principal investigator. The submission of each publication is subject to the approval of the principal investigator. The results of this study may be published or presented at scientific meetings after approval by the PI and always after anonymization of the subjects' personal data in accordance with Act No. 101/2000 Coll., on the protection of personal data.
Data sharing details ↗ · www.mou.cz
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Masaryk Memorial Cancer Institute