Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)NCT07593365
Clinical Application of Vagus Nerve Stimulation Combined With Immunoregulatory T Cells in Alleviating Aromatase Inhibitor-Induced Pain
A study testing transcutaneous auricular vagus nerve stimulation in people with Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) and Breast Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation, also called taVNS, can help relieve aromatase inhibitor-related joint and muscle pain in adult women with hormone receptor-positive breast cancer. The main questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS), Breast Cancer, Pain Alleviation
- What is being tested?
- transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged over 18 years;
- Patients with pathologically confirmed stage I-III primary breast cancer;
- Patients who have recovered from systemic symptoms related to surgery, radiotherapy, or chemotherapy;
- Patients with estrogen receptor- and/or progesterone receptor-positive breast cancer who are receiving aromatase inhibitor therapy and have aromatase inhibitor-related musculoskeletal pain, with a score greater than 3 on the Worst Pain item of the Brief Pain Inventory (BPI-WP);
- Patients who have received aromatase inhibitor therapy for more than 30 days and are expected to continue treatment for more than 1 year;
- Patients who voluntarily agree to participate in this study and sign the informed consent form.
- For participants receiving combined IL-2 treatment, the following additional criterion applies:
- Pain relief rate of less than 50% after taVNS treatment and a lower peripheral blood Treg count than before treatment.
Who cannot join
- Patients with advanced breast cancer;
- Patients with other significant organ dysfunction, such as major cardiovascular disease, diabetes mellitus, or hyperthyroidism;
- Patients with other cancers;
- Patients with a history of fracture or surgery around the painful joint area within the past 6 months;
- Patients currently receiving corticosteroids or opioid therapy;
- Patients with contraindications to vagus nerve stimulation;
Show all 13Show fewer
- Patients who are unable to communicate normally, such as those with cognitive impairment or hearing impairment;
- Patients who have participated in another clinical trial within the past 1 month.
- For participants receiving combined IL-2 treatment, the following additional exclusion criteria apply:
- Severe cardiac or renal disease, or hematologic disease;
- Previous IL-2-related toxic reaction or allergy;
- Use of other biologic agents or immunosuppressive drugs within the past 1 month;
- Any other condition that the investigator considers unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Pei Li, M.D, +86-13126762029, pli@stu.pku.edu.cn
About this study
The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation, also called taVNS, can help relieve aromatase inhibitor-related joint and muscle pain in adult women with hormone receptor-positive breast cancer.
The main questions this study aims to answer are:
Read more
- Does taVNS reduce pain caused by aromatase inhibitor treatment?
- Does taVNS improve quality of life, mood symptoms, and the need for pain medicine?
- What side effects or medical problems occur during treatment?
Researchers will compare active taVNS with sham stimulation. Participants in both groups will receive mild electrical stimulation around the ear, but the sham stimulation will be applied to an area not expected to activate the vagus nerve.
Participants will:
- Be randomly assigned to active taVNS or sham stimulation
- Receive one 30-minute treatment session every day for 28 days
- Complete pain, mood, and quality-of-life questionnaires before treatment, after treatment, and during follow-up
- Report pain medicine use and any side effects
- Provide small blood samples to measure inflammatory markers, T-cell profiles, and tumor markers
Participants will be followed for up to 6 months after treatment. For some participants who do not have enough pain relief after taVNS, an optional second-stage study may be offered. In this stage, participants may receive low-dose interleukin-2, also called IL-2, by injection every other day for 2 weeks.
- Conditions
- Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS), Breast Cancer, Pain Alleviation
- Being tested
- transcutaneous auricular vagus nerve stimulation, sham stimulation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagus nerve stimulationDevice
Also called taVNS
Electrodes will be placed on specific areas of the participant's left external ear that are mainly innervated by the auricular branch of the vagus nerve. The electrodes will be connected to an electrical stimulation device, and stimulation will be delivered at tolerable intensity using preset study parameters. Treatment will be given once daily for 28 consecutive days.
sham stimulationDevice
Compared with transcutaneous auricular vagus nerve stimulation group, electrodes will be placed on different areas of the participant's left external ear that are not innervated by the auricular branch of the vagus nerve. The electrodes will be connected to an electrical stimulation device, and stimulation will be delivered at tolerable intensity using preset study parameters. Treatment will be given once daily for 28 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous auricular vagus nerve stimulation group | Active comparator | Electrodes will be placed on specific areas of the participant's left external ear that are mainly innervated by the auricular branch of the vagus nerve. The electrodes will be connected to an electrical stimulation device, and stimulation will be delivered at tolerable intensity using preset study parameters. Treatment will be given once daily for 28 consecutive days. Receives: Device: transcutaneous auricular vagus nerve stimulation |
| sham stimulation group | Sham comparator | Compared with transcutaneous auricular vagus nerve stimulation group, electrodes will be placed on different areas of the participant's left external ear that are not innervated by the auricular branch of the vagus nerve. The electrodes will be connected to an electrical stimulation device, and stimulation will be delivered at tolerable intensity using preset study parameters. Treatment will be given once daily for 28 consecutive days. Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain relief rate of patients at the end of the 4-week treatment period
Measured: From enrollment to the end of treatment at 4 weeks.
Secondary outcomes (8)
Pain relief rate at follow-up
Measured: At 1, 2, 3, and 6 months after completion of treatment.
Dosage of analgesic drugs
Measured: At 1, 2, 3, and 6 months after completion of treatment.
Depression scores
PHQ-9 is used to measure depression. PHQ-9 ( unabbreviated scale title: Patient Health Questionnaire-9) Minimum Value: 0 Maximum Value: 27 Score Interpretation: Higher scores mean a WORSE outcome. Details:The PHQ-9 is a screening tool for depression. A higher score indicates more severe depressive symptoms. Generally, scores are interpreted as follows: 0-4 (Minimal), 5-9 (Mild), 10-14 (Moderate), 15-19 (Moderately Severe), and 20-27 (Severe) depression.
Measured: At 1, 2, 3, and 6 months after completion of treatment.
Anxiety scores
GAD-7 is used to measure anxiety. GAD-7 (unabbreviated scale title: Generalized Anxiety Disorder-7) Minimum Value: 0 Maximum Value: 21 Score Interpretation: Higher scores mean a WORSE outcome. Details:The GAD-7 measures the severity of generalized anxiety disorder. A higher score reflects more frequent and severe anxiety symptoms. Typical interpretations are: 0-4 (Minimal), 5-9 (Mild), 10-14 (Moderate), and 15-21 (Severe) anxiety.
Measured: At 1, 2, 3, and 6 months after completion of treatment.
Quality of life score
Quality of life assessed by the EuroQol 5-Dimension 5-Level questionnaire and EuroQol Visual Analogue Scale
Description:
Quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) and the EuroQol Visual Analogue Scale (EQ VAS). For the EQ-5D-5L descriptive system, scores range from 5 to 25, with higher scores indicating worse health status. For the EQ VAS, scores range from 0 to 100, with higher scores indicating better self-rated health status.
Measured: At 1, 2, 3, and 6 months after completion of treatment.
Plasma inflammatory marker levels
Measured: Baseline, immediately after completion of treatment, and 6 months after completion of treatment.
The proportion of T cells in the blood
Measured: Baseline, immediately after completion of treatment, and 6 months after completion of treatment.
The count of T cells in the blood
Measured: Baseline, immediately after completion of treatment, and 6 months after completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start6 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593365
- Sponsor's protocol ID
- 2026PHB256-001
- Other IDs
- 82571385
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect patient privacy and ensure the security of clinical data, the individual participant data (IPD) collected in this study will be used only for scientific analysis and publication related to this trial. No public disclosure, sharing, or uploading to public repositories is planned. Therefore, IPD will not be made available.
Publications
Zhang S, Zhao Y, Qin Z, Han Y, He J, Zhao B, Wang L, Duan Y, Huo J, Wang T, Wang Y, Rong P. Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Insomnia Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2451217. doi: 10.1001/jamanetworkopen.2024.51217.
PubMed 39680406Zhang Q, Hresko ME, Picton LK, Su L, Hollander MJ, Nunez-Cruz S, Zhang Z, Assenmacher CA, Sockolosky JT, Garcia KC, Milone MC. A human orthogonal IL-2 and IL-2Rbeta system enhances CAR T cell expansion and antitumor activity in a murine model of leukemia. Sci Transl Med. 2021 Dec 22;13(625):eabg6986. doi: 10.1126/scitranslmed.abg6986. Epub 2021 Dec 22.
PubMed 34936380Ren Z, Zhang A, Sun Z, Liang Y, Ye J, Qiao J, Li B, Fu YX. Selective delivery of low-affinity IL-2 to PD-1+ T cells rejuvenates antitumor immunity with reduced toxicity. J Clin Invest. 2022 Feb 1;132(3):e153604. doi: 10.1172/JCI153604.
PubMed 35104810Miao M, Li Y, Huang B, Chen J, Jin Y, Shao M, Zhang X, Sun X, He J, Li Z. Treatment of Active Idiopathic Inflammatory Myopathies by Low-Dose Interleukin-2: A Prospective Cohort Pilot Study. Rheumatol Ther. 2021 Jun;8(2):835-847. doi: 10.1007/s40744-021-00301-3. Epub 2021 Apr 14.
PubMed 33852146Zhang X, Miao M, Zhang R, Liu X, Zhao X, Shao M, Liu T, Jin Y, Chen J, Liu H, Zhang X, Li Y, Zhou Y, Yang Y, Li R, Yao H, Liu Y, Li C, Li Y, Ren L, Su Y, Sun X, He J, Li Z. Efficacy and safety of low-dose interleukin-2 in combination with methotrexate in patients with active rheumatoid arthritis: a randomized, double-blind, placebo-controlled phase 2 trial. Signal Transduct Target Ther. 2022 Mar 7;7(1):67. doi: 10.1038/s41392-022-00887-2.
PubMed 35250032He J, Chen J, Miao M, Zhang R, Cheng G, Wang Y, Feng R, Huang B, Luan H, Jia Y, Jin Y, Zhang X, Shao M, Wang Y, Zhang X, Li J, Zhao X, Wang H, Liu T, Xiao X, Zhang X, Su Y, Mu R, Ye H, Li R, Liu X, Liu Y, Li C, Liu H, Hu F, Guo J, Liu W, Zhang WB, Jacob A, Ambrus JL Jr, Ding C, Yu D, Sun X, Li Z. Efficacy and Safety of Low-Dose Interleukin 2 for Primary Sjogren Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241451. doi: 10.1001/jamanetworkopen.2022.41451.
PubMed 36355371He J, Zhang X, Wei Y, Sun X, Chen Y, Deng J, Jin Y, Gan Y, Hu X, Jia R, Xu C, Hou Z, Leong YA, Zhu L, Feng J, An Y, Jia Y, Li C, Liu X, Ye H, Ren L, Li R, Yao H, Li Y, Chen S, Zhang X, Su Y, Guo J, Shen N, Morand EF, Yu D, Li Z. Low-dose interleukin-2 treatment selectively modulates CD4(+) T cell subsets in patients with systemic lupus erythematosus. Nat Med. 2016 Sep;22(9):991-3. doi: 10.1038/nm.4148. Epub 2016 Aug 8.
PubMed 27500725Yang Y, Zhang R, Zhong Z, Li J, Feng Y. Efficacy of transauricular vagus nerve stimulation for the treatment of chemotherapy-induced painful peripheral neuropathy: a randomized controlled exploratory study. Neurol Sci. 2024 May;45(5):2289-2300. doi: 10.1007/s10072-023-07229-2. Epub 2023 Dec 8.
PubMed 38063922Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23.
PubMed 30217648Abdullahi A, Wong TWL, Ng SSM. Putative role of non-invasive vagus nerve stimulation in cancer pathology and immunotherapy: Can this be a hidden treasure, especially for the elderly? Cancer Med. 2023 Sep;12(18):19081-19090. doi: 10.1002/cam4.6466. Epub 2023 Aug 17.
PubMed 37587897Shi X, Hu Y, Zhang B, Li W, Chen JD, Liu F. Ameliorating effects and mechanisms of transcutaneous auricular vagal nerve stimulation on abdominal pain and constipation. JCI Insight. 2021 Jul 22;6(14):e150052. doi: 10.1172/jci.insight.150052.
PubMed 34138761Barbanti P, Grazzi L, Egeo G, Padovan AM, Liebler E, Bussone G. Non-invasive vagus nerve stimulation for acute treatment of high-frequency and chronic migraine: an open-label study. J Headache Pain. 2015;16:61. doi: 10.1186/s10194-015-0542-4. Epub 2015 Jun 30.
PubMed 26123825Arem H, Sorkin M, Cartmel B, Fiellin M, Capozza S, Harrigan M, Ercolano E, Zhou Y, Sanft T, Gross C, Schmitz K, Neogi T, Hershman D, Ligibel J, Irwin ML. Exercise adherence in a randomized trial of exercise on aromatase inhibitor arthralgias in breast cancer survivors: the Hormones and Physical Exercise (HOPE) study. J Cancer Surviv. 2016 Aug;10(4):654-62. doi: 10.1007/s11764-015-0511-6. Epub 2016 Jan 19.
PubMed 26782031van Hellemond IEG, Geurts SME, Tjan-Heijnen VCG. Current Status of Extended Adjuvant Endocrine Therapy in Early Stage Breast Cancer. Curr Treat Options Oncol. 2018 Apr 27;19(5):26. doi: 10.1007/s11864-018-0541-1.
PubMed 29704066
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Vagus Nerve Stimulation Combined With Immunoregulatory T Cells in Alleviating Aromatase Inhibitor-Induced Pain
- ClinicalTrials.gov ID
- NCT07593365
- Acronym / sponsor ID
- 2026PHB256-001
- Conditions
- Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS), Breast Cancer, Pain Alleviation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 6 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 May 2026 (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.
The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation, also called taVNS, can help relieve aromatase inhibitor-related joint and muscle pain in adult women with hormone receptor-positive breast cancer.
The main questions this study aims to answer are:
- Does taVNS reduce pain caused by aromatase inhibitor treatment?
- Does taVNS improve quality of life, mood symptoms, and the need for pain medicine?
- What side effects or medical problems occur during treatment?
Researchers will compare active taVNS with sham stimulation. Participants in both groups will receive mild electrical stimulation around the ear, but the sham stimulation will be applied to an area not expected to activate the vagus nerve.
Participants will:
- Be randomly assigned to active taVNS or sham stimulation
- Receive one 30-minute treatment session every day for 28 days
- Complete pain, mood, and quality-of-life questionnaires before treatment, after treatment, and during follow-up
- Report pain medicine use and any side effects
- Provide small blood samples to measure inflammatory markers, T-cell profiles, and tumor markers
Participants will be followed for up to 6 months after treatment. For some participants who do not have enough pain relief after taVNS, an optional second-stage study may be offered. In this stage, participants may receive low-dose interleukin-2, also called IL-2, by injection every other day for 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous auricular vagus nerve stimulation group | Active comparator | Device: transcutaneous auricular vagus nerve stimulationElectrodes will be placed on specific areas of the participant's left external ear that are mainly innervated by the auricular branch of the vagus nerve. The electrodes will be connected to an electrical stimulation device, and stimulation will be delivered at tolerable intensity using preset study parameters. Treatment will be given once daily for 28 consecutive days. |
| sham stimulation group | Sham comparator | Device: sham stimulationCompared with transcutaneous auricular vagus nerve stimulation group, electrodes will be placed on different areas of the participant's left external ear that are not innervated by the auricular branch of the vagus nerve. The electrodes will be connected to an electrical stimulation device, and stimulation will be delivered at tolerable intensity using preset study parameters. Treatment will be given once daily for 28 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female participants aged over 18 years;
- Patients with pathologically confirmed stage I-III primary breast cancer;
- Patients who have recovered from systemic symptoms related to surgery, radiotherapy, or chemotherapy;
- Patients with estrogen receptor- and/or progesterone receptor-positive breast cancer who are receiving aromatase inhibitor therapy and have aromatase inhibitor-related musculoskeletal pain, with a score greater than 3 on the Worst Pain item of the Brief Pain Inventory (BPI-WP);
- Patients who have received aromatase inhibitor therapy for more than 30 days and are expected to continue treatment for more than 1 year;
Key exclusion criteria (13 listed)
- Patients with advanced breast cancer;
- Patients with other significant organ dysfunction, such as major cardiovascular disease, diabetes mellitus, or hyperthyroidism;
- Patients with other cancers;
- Patients with a history of fracture or surgery around the painful joint area within the past 6 months;
- Patients currently receiving corticosteroids or opioid therapy;
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 |
|---|---|---|
| transcutaneous auricular vagus nerve stimulationAlso: taVNSElectrodes will be placed on specific areas of the participant's left external ear that are mainly innervated by the auricular branch of the vagus nerve. The electrodes will be connected to an electrical stimulation device, and stimulation will be delivered at tolerable intensity using preset study parameters. Treatment will be given once daily for 28 consecutive days. | Device | transcutaneous auricular vagus nerve stimulation group |
| sham stimulationCompared with transcutaneous auricular vagus nerve stimulation group, electrodes will be placed on different areas of the participant's left external ear that are not innervated by the auricular branch of the vagus nerve. The electrodes will be connected to an electrical stimulation device, and stimulation will be delivered at tolerable intensity using preset study parameters. Treatment will be given once daily for 28 consecutive days. | Device | sham stimulation group |
Primary outcome
The pain relief rate of patients at the end of the 4-week treatment period
Time frame: From enrollment to the end of treatment at 4 weeks.
8 secondary outcomes
Pain relief rate at follow-up
Time frame: At 1, 2, 3, and 6 months after completion of treatment.
Dosage of analgesic drugs
Time frame: At 1, 2, 3, and 6 months after completion of treatment.
Depression scores
Time frame: At 1, 2, 3, and 6 months after completion of treatment.
Anxiety scores
Time frame: At 1, 2, 3, and 6 months after completion of treatment.
Quality of life score
Time frame: At 1, 2, 3, and 6 months after completion of treatment.
Plasma inflammatory marker levels
Time frame: Baseline, immediately after completion of treatment, and 6 months after completion of treatment.
The proportion of T cells in the blood
Time frame: Baseline, immediately after completion of treatment, and 6 months after completion of treatment.
The count of T cells in the blood
Time frame: Baseline, immediately after completion of treatment, and 6 months after completion of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 39680406Zhang S, Zhao Y, Qin Z, Han Y, He J, Zhao B, Wang L, Duan Y, Huo J, Wang T, Wang Y, Rong P. Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Insomnia Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2451217. doi: 10.1001/jamanetworkopen.2024.51217.
- Background: PubMed 34936380Zhang Q, Hresko ME, Picton LK, Su L, Hollander MJ, Nunez-Cruz S, Zhang Z, Assenmacher CA, Sockolosky JT, Garcia KC, Milone MC. A human orthogonal IL-2 and IL-2Rbeta system enhances CAR T cell expansion and antitumor activity in a murine model of leukemia. Sci Transl Med. 2021 Dec 22;13(625):eabg6986. doi: 10.1126/scitranslmed.abg6986. Epub 2021 Dec 22.
- Background: PubMed 35104810Ren Z, Zhang A, Sun Z, Liang Y, Ye J, Qiao J, Li B, Fu YX. Selective delivery of low-affinity IL-2 to PD-1+ T cells rejuvenates antitumor immunity with reduced toxicity. J Clin Invest. 2022 Feb 1;132(3):e153604. doi: 10.1172/JCI153604.
- Background: PubMed 33852146Miao M, Li Y, Huang B, Chen J, Jin Y, Shao M, Zhang X, Sun X, He J, Li Z. Treatment of Active Idiopathic Inflammatory Myopathies by Low-Dose Interleukin-2: A Prospective Cohort Pilot Study. Rheumatol Ther. 2021 Jun;8(2):835-847. doi: 10.1007/s40744-021-00301-3. Epub 2021 Apr 14.
- Background: PubMed 35250032Zhang X, Miao M, Zhang R, Liu X, Zhao X, Shao M, Liu T, Jin Y, Chen J, Liu H, Zhang X, Li Y, Zhou Y, Yang Y, Li R, Yao H, Liu Y, Li C, Li Y, Ren L, Su Y, Sun X, He J, Li Z. Efficacy and safety of low-dose interleukin-2 in combination with methotrexate in patients with active rheumatoid arthritis: a randomized, double-blind, placebo-controlled phase 2 trial. Signal Transduct Target Ther. 2022 Mar 7;7(1):67. doi: 10.1038/s41392-022-00887-2.
- Background: PubMed 36355371He J, Chen J, Miao M, Zhang R, Cheng G, Wang Y, Feng R, Huang B, Luan H, Jia Y, Jin Y, Zhang X, Shao M, Wang Y, Zhang X, Li J, Zhao X, Wang H, Liu T, Xiao X, Zhang X, Su Y, Mu R, Ye H, Li R, Liu X, Liu Y, Li C, Liu H, Hu F, Guo J, Liu W, Zhang WB, Jacob A, Ambrus JL Jr, Ding C, Yu D, Sun X, Li Z. Efficacy and Safety of Low-Dose Interleukin 2 for Primary Sjogren Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241451. doi: 10.1001/jamanetworkopen.2022.41451.
- Background: PubMed 27500725He J, Zhang X, Wei Y, Sun X, Chen Y, Deng J, Jin Y, Gan Y, Hu X, Jia R, Xu C, Hou Z, Leong YA, Zhu L, Feng J, An Y, Jia Y, Li C, Liu X, Ye H, Ren L, Li R, Yao H, Li Y, Chen S, Zhang X, Su Y, Guo J, Shen N, Morand EF, Yu D, Li Z. Low-dose interleukin-2 treatment selectively modulates CD4(+) T cell subsets in patients with systemic lupus erythematosus. Nat Med. 2016 Sep;22(9):991-3. doi: 10.1038/nm.4148. Epub 2016 Aug 8.
- Background: PubMed 38063922Yang Y, Zhang R, Zhong Z, Li J, Feng Y. Efficacy of transauricular vagus nerve stimulation for the treatment of chemotherapy-induced painful peripheral neuropathy: a randomized controlled exploratory study. Neurol Sci. 2024 May;45(5):2289-2300. doi: 10.1007/s10072-023-07229-2. Epub 2023 Dec 8.
- Background: PubMed 30217648Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23.
- Background: PubMed 37587897Abdullahi A, Wong TWL, Ng SSM. Putative role of non-invasive vagus nerve stimulation in cancer pathology and immunotherapy: Can this be a hidden treasure, especially for the elderly? Cancer Med. 2023 Sep;12(18):19081-19090. doi: 10.1002/cam4.6466. Epub 2023 Aug 17.
- Background: PubMed 34138761Shi X, Hu Y, Zhang B, Li W, Chen JD, Liu F. Ameliorating effects and mechanisms of transcutaneous auricular vagal nerve stimulation on abdominal pain and constipation. JCI Insight. 2021 Jul 22;6(14):e150052. doi: 10.1172/jci.insight.150052.
- Background: PubMed 26123825Barbanti P, Grazzi L, Egeo G, Padovan AM, Liebler E, Bussone G. Non-invasive vagus nerve stimulation for acute treatment of high-frequency and chronic migraine: an open-label study. J Headache Pain. 2015;16:61. doi: 10.1186/s10194-015-0542-4. Epub 2015 Jun 30.
- Individual participant dataSharing planned: No. To protect patient privacy and ensure the security of clinical data, the individual participant data (IPD) collected in this study will be used only for scientific analysis and publication related to this trial. No public disclosure, sharing, or uploading to public repositories is planned. Therefore, IPD will not be made available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous auricular vagus nerve stimulation in people with Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) and Breast Cancer, run by Peking University People's Hospital 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 8 inclusion and 13 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: opening soon, as of the sponsor's last update on 18 May 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Feng, M.D (+86-010-88325590, fengyi@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain relief rate of patients at the end of the 4-week treatment period (time frame: From enrollment to the end of treatment at 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07593365, which also lists 14 linked publications.
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 May 2026.