AcupuncturePACTNCT05528263
Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial)
A study testing Acupuncture and Nature scenery with a relaxation exercise in people with Acupuncture and Early-stage Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research is being done to determine whether acupuncture can help prevent or lessen chemotherapy-induced peripheral neuropathy (CIPN), a side effect of some kinds of chemotherapy that causes pain, numbness, tingling, swelling, or muscle weakness mostly in the hands or feet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acupuncture, Early-stage Breast Cancer, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Acupuncture and Nature scenery with a relaxation exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2022to 30 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of histologically proven stage I-III breast cancer, without evidence of distant metastasis
- Scheduled to receive adjuvant or neoadjuvant taxane-based chemotherapy (with or without HER-2 directed therapy or with or without immunotherapy). Patient must enroll before the second infusion of a taxane.
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Signed informed consent
Who cannot join
- Previous receipt of CIPN-inducing chemotherapy agents (1 prior dose of a taxane is allowed).
- Unstable cardiac disease or myocardial infarction within 6 months prior to study entry
- Wearing a pacemaker or implantable cardioverter-defibrillator
- Uncontrolled seizure disorder
- History of pre-existing peripheral neuropathy
- Use of acupuncture within the 3 months prior to study enrollment
Show all 9Show fewer
- Self-report of any CIPN symptoms via staff-administered PRO-CTCAE CIPN, defined as either:
- Report of "mild", "moderate", "severe", "very severe" on the Severity Item on PRO-CTCAE CIPN assessment
- Report of "a little bit", "somewhat", "quite a bit", "very much" on the Interfere Item on PRO-CTCAE CIPN assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture, A Randomized Controlled Trial (PACT Trial)
This research is being done to determine whether acupuncture can help prevent or lessen chemotherapy-induced peripheral neuropathy (CIPN), a side effect of some kinds of chemotherapy that causes pain, numbness, tingling, swelling, or muscle weakness mostly in the hands or feet.
This research will also help determine whether acupuncture can improve quality of life in patients receiving taxane-based chemotherapy for the treatment of breast cancer.
Read more
The names of the study activities involved in this study are/is:
- Acupuncture treatments for participants in the Acupuncture Group
- Nature videos with a relaxation exercise for participants in the Relaxation/ Exercise Group
The Comprehensive and Integrative Medicine Institute (CIMI) of South Korea is supporting this research study by providing funding.
Read the detailed description
This study randomly assigns patients with breast cancer who are starting a chemotherapy program that includes a Taxane to one of two groups:
- The Acupuncture Group will receive acupuncture treatments for 12 weeks during chemotherapy treatment.
- The Relaxation Exercise Group will receive a program of weekly videos accompanied by a relaxation exercise. Both programs will last 12 weeks.
Participants will be asked to complete questionnaire 12 weeks after the completion of the acupuncture or relaxation exercise program, so participants be on this research study for up to 24 weeks (6 months).
It is expected that about 80 people will take part in this research study.
- Conditions
- Acupuncture, Early-stage Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
- Being tested
- Acupuncture, Nature scenery with a relaxation exercise
- Keywords
- Acupuncture, Early-stage Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions).
Nature scenery with a relaxation exerciseOther
Watch nature scenery videos with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions)
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | * Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline.
40 participants will be randomized into the acupuncture Arm:
* The acupuncture arm will receive a standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions). Receives: Device: Acupuncture |
| Nature scenery videos with relaxation exercise | Active comparator | * Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline.
40 Participants will be randomized into the Control Arm:
* The control arm will receive and watch videos with nature scenery with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions) Receives: Other: Nature scenery with a relaxation exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of CIPN, defined by mean change in EORTC QLQ-CIPN20 sensory score
The primary endpoint is the change in severity of CIPN, defined as the average change from baseline (12-week to baseline) in the EORTC Quality of Life - Chemotherapy Induced Neuropathy 20 (QLQ-CIPN20) sensory subscale score (9 items). Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. A higher score means greater severity of CIPN. The total and three domain scores are calculated and linearly transformed into 0-100 scales according to the scoring manual. A score of 100 indicates the worst CIPN symptom.
Measured: baseline to 12 weeks
Secondary outcomes (7)
Incidence of CIPN between intervention arms - AOCIPN
AOCIPN is defined as an increase of 2.5 points or larger in the QLQ-CIPN 20 sensory score at any time point relative to baseline or reported "mild" or "a little bit" or higher in PRO-CTCAE CIPN "Severity" and "Interference" items during the study intervention period (baseline to week 12).
Measured: baseline to week 12
Incidence of CIPN between intervention arms - G2CIPN
G2CIPN is defined a 20-point or greater increase from baseline at any time point in QLQ-CIPN20 total score or grade-2 in PRO-CTCAE CIPN, which is defined as reporting the severity of numbness and/or tingling AND interference of with daily activities ≥ 1 (mild/ a little bit) during the study period at any time point.
Measured: baseline to 12 Weeks
Relative dose intensity (RDI)
Received or relative dose intensity (RDI) refers to the amount and timing of chemotherapy actually delivered versus the expected dose and schedule. The relative dose intensity (RDI) will be calculated for each participant and compared between treatment arms using two-sample t-tests or Wilcoxon rank-sum tests, depending upon normality of the data.
Measured: baseline to week 24
Maximum CIPN score
Maximum CIPN score will be assessed through the EORTC Quality of Life - Chemotherapy Induced Neuropathy 20 (QLQ-CIPN20) sensory subscale score (9 items). Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. A higher score means greater severity of CIPN. The maximum CIPN sensory score change (post-pre) for each patient during the intervention will be compared between the randomized treatment arms.
Measured: pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks
Changes in mean scores of pain intensity
CIPN pain intensity will be measured using a past 7 days, 0-10 numerical rating scale diary. A higher score indicates greater pain intensity.
Measured: Baseline, Week 12, and Week 24
Changes in the total mean scores of the Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item self-reported questionnaire that assesses sleep quality for the preceding month. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: Baseline, Week 12, and Week 24
Changes in the total and subscales of EORTC QLQ-C30
Quality of life and cancer treatment-related symptoms will be assessed using the EORTC-QLQ-C30. The QLQ-C30 consists of 30 items that are grouped within global health status/quality of life (1 - 7 points, higher scores = greater quality of life), functional (e.g., physical or cognitive; 0 - 100 transformed scores, higher = better function), or symptom (e.g., insomnia, fatigue; 0 - 100 transformed scores, higher = worse symptoms) subscales.
Measured: Baseline, Week 12, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start8 Sep 2022
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Comprehensive and Integrative Medicine Institute of South Korea
- Responsible party
- Principal investigator, Weidong Lu, MB, MPH, PhD, Dana-Farber Cancer Institute
- Investigators
- Weidong Lu, MB, MPH, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528263
- Sponsor's protocol ID
- 22-269
- Acronym
- PACT
- Status last verified
- Feb 2026
- First submitted
- 29 Aug 2022
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture, A Randomized Controlled Trial (PACT Trial)
- ClinicalTrials.gov ID
- NCT05528263
- Acronym / sponsor ID
- PACT / 22-269
- Conditions
- Acupuncture, Early-stage Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
- Keywords
- Acupuncture, Early-stage Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- The Comprehensive and Integrative Medicine Institute of South Korea
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 6 Sep 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.
This research is being done to determine whether acupuncture can help prevent or lessen chemotherapy-induced peripheral neuropathy (CIPN), a side effect of some kinds of chemotherapy that causes pain, numbness, tingling, swelling, or muscle weakness mostly in the hands or feet.
This research will also help determine whether acupuncture can improve quality of life in patients receiving taxane-based chemotherapy for the treatment of breast cancer.
The names of the study activities involved in this study are/is:
- Acupuncture treatments for participants in the Acupuncture Group
- Nature videos with a relaxation exercise for participants in the Relaxation/ Exercise Group
The Comprehensive and Integrative Medicine Institute (CIMI) of South Korea is supporting this research study by providing funding.
Detailed description
This study randomly assigns patients with breast cancer who are starting a chemotherapy program that includes a Taxane to one of two groups:
- The Acupuncture Group will receive acupuncture treatments for 12 weeks during chemotherapy treatment.
- The Relaxation Exercise Group will receive a program of weekly videos accompanied by a relaxation exercise. Both programs will last 12 weeks.
Participants will be asked to complete questionnaire 12 weeks after the completion of the acupuncture or relaxation exercise program, so participants be on this research study for up to 24 weeks (6 months).
It is expected that about 80 people will take part in this research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: Acupuncture* Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline. 40 participants will be randomized into the acupuncture Arm: * The acupuncture arm will receive a standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions). |
| Nature scenery videos with relaxation exercise | Active comparator | Other: Nature scenery with a relaxation exercise* Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline. 40 Participants will be randomized into the Control Arm: * The control arm will receive and watch videos with nature scenery with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of histologically proven stage I-III breast cancer, without evidence of distant metastasis
- Scheduled to receive adjuvant or neoadjuvant taxane-based chemotherapy (with or without HER-2 directed therapy or with or without immunotherapy). Patient must enroll before the second infusion of a taxane.
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Signed informed consent
Key exclusion criteria (9 listed)
- Previous receipt of CIPN-inducing chemotherapy agents (1 prior dose of a taxane is allowed).
- Unstable cardiac disease or myocardial infarction within 6 months prior to study entry
- Wearing a pacemaker or implantable cardioverter-defibrillator
- Uncontrolled seizure disorder
- History of pre-existing peripheral neuropathy
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 |
|---|---|---|
| AcupunctureStandardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions). | Device | Acupuncture |
| Nature scenery with a relaxation exerciseWatch nature scenery videos with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions) | Other | Nature scenery videos with relaxation exercise |
Primary outcome
Change in severity of CIPN, defined by mean change in EORTC QLQ-CIPN20 sensory score
Time frame: baseline to 12 weeks
The primary endpoint is the change in severity of CIPN, defined as the average change from baseline (12-week to baseline) in the EORTC Quality of Life - Chemotherapy Induced Neuropathy 20 (QLQ-CIPN20) sensory subscale score (9 items). Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. A higher score means greater severity of CIPN. The total and three domain scores are calculated and linearly transformed into 0-100 scales according to the scoring manual. A score of 100 indicates the worst CIPN symptom.
7 secondary outcomes
Incidence of CIPN between intervention arms - AOCIPN
Time frame: baseline to week 12
Incidence of CIPN between intervention arms - G2CIPN
Time frame: baseline to 12 Weeks
Relative dose intensity (RDI)
Time frame: baseline to week 24
Maximum CIPN score
Time frame: pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks
Changes in mean scores of pain intensity
Time frame: Baseline, Week 12, and Week 24
Changes in the total mean scores of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Week 12, and Week 24
Changes in the total and subscales of EORTC QLQ-C30
Time frame: Baseline, Week 12, and Week 24
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 24 Feb 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Weidong Lu, MB, MPH, PhD principal investigator
Dana-Farber Cancer Institute
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 and Nature scenery with a relaxation exercise in people with Acupuncture and Early-stage Breast Cancer, run by Dana-Farber Cancer Institute 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 9 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 24 Feb 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 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.
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?
Change in severity of CIPN, defined by mean change in EORTC QLQ-CIPN20 sensory score (time frame: baseline to 12 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 24 Feb 2026.