Breast CancerPhase 2NCT05417451
Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
A Phase 2 study testing Acupuncture in people with Breast Cancer, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The objectives of this study to explore whether acupuncture can improve the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) in survivors of breast cancer and explore biomarker changes after the acupuncture intervention. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 26 Feb 2025
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with histologically confirmed stage 0, I, II, or III breast cancer
- who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior and within 5 years
- are currently receiving adjuvant endocrine therapy
- are able to read and speak English
- with self-reported pain, fatigue, sleep disturbance in the last three months and their "worst" severity rating ≥ 3 (0-10 numeric rating scale) for at least two of the three symptoms
Who cannot join
- have self-reported hospitalization for psychiatric illness within the past 2 years
- have a bleeding disorder
- physically or cognitively unable to complete the study procedures
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago College of Nursing
Chicago, Illinois, 60612
About this study
The objectives of this study to explore whether acupuncture can improve the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) in survivors of breast cancer and explore biomarker changes after the acupuncture intervention. Acupuncture treatments will be provided to breast cancer survivors twice weekly for 5 weeks.
Read the detailed description
The investigators will conduct the study with early stage breast cancer survivors who have completed their primary cancer treatment. They will all receive acupuncture. Treatments will be twice weekly for 5 weeks, for 30 minutes per treatment. At baseline and post-treatment, subjects will be collected blood and stool samples, complete symptom questionnaires that measure pain, fatigue, and sleep disturbance.
- Conditions
- Breast Cancer
- Being tested
- Acupuncture
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
All participants will receive a semi-standardized acupuncture protocol (standardized points for pain, fatigue, depression, anxiety, sleep disturbance, with additional points for patient's particular pain location)
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | All subjects will receive active acupuncture. The acupuncture intervention will consist of 10 acupuncture sessions, twice weekly for 5 weeks. There will be at least 1 day in between session. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Pain Interference
Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more
Measured: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
PROMIS Fatigue
Scores range from 4-20; higher scores indicate that severe fatigue
Measured: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
PROMIS Sleep Disturbance
Scores range from 4-20; higher scores indicate that severe sleep disturbance
Measured: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Secondary outcomes (2)
PROMIS Depression
Scores range from 4-20; higher scores indicate that severe depression
Measured: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
PROMIS Anxiety
Scores range from 4-20; higher scores indicate that severe anxiety
Measured: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Nov 2021
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongjin Li, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417451
- Sponsor's protocol ID
- 2021-0840
- Status last verified
- Jul 2025
- First submitted
- 26 May 2022
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li H, Gao S, Schlaeger JM, Choi H, Xia Y, Sun J, Doorenbos AZ. Changes in Glutathione Metabolites and Reactive Oxygen Species from Baseline to Post-Treatment in Breast Cancer Survivors with Psychoneurological Symptoms Receiving Acupuncture. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251411913. doi: 10.1177/15347354251411913. Epub 2026 Feb 13.
PubMed 41685420
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05417451
- Acronym / sponsor ID
- 2021-0840
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 14 Jun 2022 (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 objectives of this study to explore whether acupuncture can improve the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) in survivors of breast cancer and explore biomarker changes after the acupuncture intervention. Acupuncture treatments will be provided to breast cancer survivors twice weekly for 5 weeks.
Detailed description
The investigators will conduct the study with early stage breast cancer survivors who have completed their primary cancer treatment. They will all receive acupuncture. Treatments will be twice weekly for 5 weeks, for 30 minutes per treatment. At baseline and post-treatment, subjects will be collected blood and stool samples, complete symptom questionnaires that measure pain, fatigue, and sleep disturbance.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupunctureAll subjects will receive active acupuncture. The acupuncture intervention will consist of 10 acupuncture sessions, twice weekly for 5 weeks. There will be at least 1 day in between session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- women with histologically confirmed stage 0, I, II, or III breast cancer
- who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior and within 5 years
- are currently receiving adjuvant endocrine therapy
- are able to read and speak English
- with self-reported pain, fatigue, sleep disturbance in the last three months and their "worst" severity rating ≥ 3 (0-10 numeric rating scale) for at least two of the three symptoms
Key exclusion criteria (4 listed)
- have self-reported hospitalization for psychiatric illness within the past 2 years
- have a bleeding disorder
- physically or cognitively unable to complete the study procedures
- pregnant women
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 |
|---|---|---|
| AcupunctureAll participants will receive a semi-standardized acupuncture protocol (standardized points for pain, fatigue, depression, anxiety, sleep disturbance, with additional points for patient's particular pain location) | Other | Acupuncture |
Primary outcome
PROMIS Pain Interference
Time frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more
PROMIS Fatigue
Time frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Scores range from 4-20; higher scores indicate that severe fatigue
PROMIS Sleep Disturbance
Time frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Scores range from 4-20; higher scores indicate that severe sleep disturbance
2 secondary outcomes
PROMIS Depression
Time frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
PROMIS Anxiety
Time frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Derived from this study: PubMed 41685420Li H, Gao S, Schlaeger JM, Choi H, Xia Y, Sun J, Doorenbos AZ. Changes in Glutathione Metabolites and Reactive Oxygen Species from Baseline to Post-Treatment in Breast Cancer Survivors with Psychoneurological Symptoms Receiving Acupuncture. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251411913. doi: 10.1177/15347354251411913. Epub 2026 Feb 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture in people with Breast Cancer, run by University of Illinois Chicago at 1 site in United States.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 23 Jul 2025. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Pain Interference (time frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)). The study lists 3 primary outcomes in all. 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 NCT05417451, which also lists 1 linked publication.
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 23 Jul 2025.