AcupunctureSTREAKNCT07132034
Stress Reduction Through Acupuncture
A study testing Acupuncture and Standard supportive care in people with Acupuncture and Breast Cancer, run by Isabell Xiang Ge at 3 sites in Switzerland.
Trial summary
This randomized controlled trial evaluates whether eight weeks of weekly acupuncture can reduce psychological distress in breast cancer patients who have recently completed primary therapy compared to standard-of-care wait-list control. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acupuncture, Breast Cancer, Survivorship
- What is being tested?
- Acupuncture and Standard supportive care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 7 Jul 2026to Sep 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
- Patients with localized breast cancer having completed primary therapy (operation +/- chemotherapy +/- radiotherapy) in the last 6 months - Distress Thermometer ≥ 5 - Age ≥ 18 years - Signed informed consent for participation of the trial
- Prior cancer is allowed
- Prior treatment - including chemotherapy - for a prior malignant tumor (including breast cancer) is allowed
- Concomitant participation in an experimental therapeutic drug trial is allowed
- Ongoing or planned Anti-her2/neu, immune checkpoint inhibitor, antihormonal and CDK4/6 inhibitor therapy or other adjuvant treatment scheduled for > 3 months during study period is allowed
- Use of other complementary methods (including mistletoe) is allowed.
Who cannot join
- Patients with language or cognitive deficits (including impaired consciousness) that are incompatible with the participation in the study
- Severe physical or psychiatric comorbidity that prevents a patient from participating in the study
- Patients incapable of giving consent
- Pregnancy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites, 3 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Isabell Xiang Ge, MD, +41 61 265 85885, isabellxiang.ge@usb.ch
- Not yet recruiting
Gesundheitszentrum Fricktal AG Frauenklinik
Rheinfelden
Dr. Rosa Jochim-Maier, +41 61 835 62 20, frauenklinik@gzf.ch
- Recruiting
Onkologie- & Hämatologiezentrums, Spital STS AG Thun
Thun
Nurgül Usluoglu, MD, +41 58 636 26 45, studienkoordinationonkologie@spitalstsag.ch
About this study
Official title: Study Protocol: Stress Reduction in Breast Cancer Patients During Transition Into Survivorship Using Acupuncture - a Randomized Wait-list-controlled Intervention Study
This randomized controlled trial evaluates whether eight weeks of weekly acupuncture can reduce psychological distress in breast cancer patients who have recently completed primary therapy compared to standard-of-care wait-list control.
Read the detailed description
Background Psychological distress is common in cancer patients-affecting roughly one-third with diagnosable mental health disorders and about half with significant psychosocial distress. This distress often spikes during diagnosis and treatment, decreases during therapy, but rises again after treatment ends. The transition from active treatment to aftercare is a particularly vulnerable phase, marked by loss of routine medical contact, fear of recurrence, ongoing side effects, and feelings of isolation. In breast cancer survivors, 20-40% experience clinically relevant distress, with many reporting unmet needs for psychological support. Chronic stress in cancer patients is linked to lower quality of life, worse treatment adherence, higher symptom burden, and poorer prognosis.
Acupuncture, a method from traditional Chinese medicine, has shown potential to reduce stress through modulation of the autonomic nervous system-reducing sympathetic overactivation and enhancing parasympathetic activity. It has been shown to improve symptoms such as pain, fatigue, and hot flushes in cancer patients, and to lower stress in other populations. However, there is almost no research on acupuncture's effect on post-treatment stress in breast cancer patients, especially in the critical early aftercare phase. Whether acupuncture can also improve resilience and treatment adherence in this context remains unknown.
Aim of the Study The study aims to investigate whether acupuncture reduces psychological distress in breast cancer patients who have recently completed primary therapy. Specifically, it tests whether the patients receiving acupuncture will have significantly lower perceived stress after eight weeks compared to a wait-list control group. Secondary objectives include exploring the effects of acupuncture on quality of life, fatigue, cognitive function, anxiety, depression, resilience, and therapy adherence, as well as documenting any adverse events.
- Conditions
- Acupuncture, Breast Cancer, Survivorship
- Being tested
- Acupuncture, Standard supportive care
- Keywords
- Integrative Oncology, Acupuncture, Breast Cancer, Survivorship, Distress
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
8 sessions of acupuncture treatment (body and auricular acupuncture) will be given once a week after randomization.
Standard supportive careOther
Supportive care according to local standards will be given which may also include face-to-face psychosocial support or the participation of support groups
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture: | Experimental | 8 sessions of acupuncture treatment, once a week Receives: Procedure: Acupuncture |
| Wait-listed control group | Placebo comparator | Supportive care according to local standards will be given which may also include face-to-face psychosocial support or the participation of support groups. 8 weeks after the assessment T1 and upon completion of assessment T2, participants will receive access to 8 sessions of weekly acupuncture treatment. Receives: Other: Standard supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress at 8 weeks of intervention
Distress is assessed after completion of 8 weeks of weekly acupuncture interventions or standard of care (SOC) by the Perceived Stress Scale (PSS-10). PSS-10 is a 10-item questionnaire widely used to assess stress levels in individuals. It measures the degree to which life has been perceived as unpredictable, uncontrollable und overloading over the last month. The responses are rated on a 5-point rating scale with a total score ranging from 0-40 while a higher total score indicating greater stress.
Measured: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Secondary outcomes (9)
Distress over the course time
Immediate changes in distress before and after the intervention will be assessed over the course of 8 weeks by the Distress Thermometer, a valid and reliable measure developed by the National Comprehensive Cancer Network for screening psychological distress in cancer patients. The German version was adapted by Mehnert et al. A score of 5 or higher at the visual analogue scale. The score ranges from 0-10 while 10 indicates a higher stress level.
Measured: Before and after each acupuncture session during the the 8 week intervention period
Quality of life assessment
Quality of life is assessed after completion of the 8 week acupuncture therapy or SOC by 30-items EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30). The score ranges from 0-100 while 100 indicates a higher quality of life.
Measured: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Anxiety
Anxiety will be measured using the validated questionnaire The Hospital Anxiety and Depression Scale (HADS) for somatically ill patients with good psychometric properties and with satisfactory internal consistency. The scale consists of 14 questions, with each question being assigned a value from 0 to 3. The total score can range from 0 to 21. Scores of 8-10 are considered borderline, 11-15 moderate, and 16 or higher severe anxiety.
Measured: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Depression
Depression will be measured using the validated questionnaire The Hospital Anxiety and Depression Scale (HADS) for somatically ill patients with good psychometric properties and with satisfactory internal consistency. The scale consists of 14 questions, with each question being assigned a value from 0 to 3. The total score can range from 0 to 21. Scores of 8-10 are considered borderline, 11-15 moderate, and 16 or higher severe depression.
Measured: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Resilience
Resilience is assessed by the Connor-Davidson Resilience Scale 10 (CD-RISC-10). It is the shortened version of a 25-items questionnaire which evaluates the patient's ability to bounce back when diagnosed with a disease. The responses are rated on a 5-point rating scale with the total score ranged from 0-40 while a higher total score indicating greater resilience.
Measured: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Therapy Adherence
Adherence to maintenance treatment will be assessed using the Medication Adherence Report Scale-V questionnaire (MARS-V) which consists of 5 items answered on a 5-points-scale. The responses range from 5-25 with higher scores indicating better adherence. Adherence to adjuvant anti-Her2 treatment will be extracted from medical records
Measured: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Adverse Events:
Adverse events of the acupuncture treatment will be recorded by the acupuncturists using standardized registration sheets at each visit
Measured: After each acupuncture session during the the 8 week intervention period
Fatigue
Cancer-related fatigue will be assessed using the 13-items Functional Assessment of Chronic Illness Therapy - Fatigue subscale (FACIT-Fatigue). The questionnaire uses 13 items, each scored on a 0-4 Likert scale. The total possible score ranges from 0 to 52, where higher scores indicate less fatigue, and lower scores indicate greater fatigue.
Measured: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Self-reported cognitive impairment
Self-reported cognitive impairment will be carried out using the Attention Function Index (AFI), a 13-item questionnaire primarily used for breast cancer patients which measures perceived effectiveness of activities requiring attention. The answers are ranged on a numerical rating scale (0-10) with higher scores indicating better functioning. The AFI has shown correlations with measures of ability to concentrate, cognitive failures, confusion and fatigue
Measured: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start7 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionSep 2029 (estimated)
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.
- 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
- Model description
- Randomized, controlled, non-blinded, two-arm clinical study
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isabell Xiang Ge
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss GO Trial Group
- Responsible party
- Sponsor-investigator, Isabell Xiang Ge, University Hospital, Basel, Switzerland
- Investigators
- Viola Heinzelmann-Schwarz, Prof.MD, Study chair, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132034
- Sponsor's protocol ID
- 2025-01072;bb21HeinzelmannSch3
- Other IDs
- 2025
- Acronym
- STREAK
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol: Stress Reduction in Breast Cancer Patients During Transition Into Survivorship Using Acupuncture - a Randomized Wait-list-controlled Intervention Study
- ClinicalTrials.gov ID
- NCT07132034
- Acronym / sponsor ID
- STREAK / 2025-01072;bb21HeinzelmannSch3
- Conditions
- Acupuncture, Breast Cancer, Survivorship
- Keywords
- Integrative Oncology, Acupuncture, Breast Cancer, Survivorship, Distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Isabell Xiang GeUniversity, hospital or other
- Collaborators
- Swiss GO Trial Group
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 20 Aug 2025 (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 randomized controlled trial evaluates whether eight weeks of weekly acupuncture can reduce psychological distress in breast cancer patients who have recently completed primary therapy compared to standard-of-care wait-list control.
Detailed description
Background Psychological distress is common in cancer patients-affecting roughly one-third with diagnosable mental health disorders and about half with significant psychosocial distress. This distress often spikes during diagnosis and treatment, decreases during therapy, but rises again after treatment ends. The transition from active treatment to aftercare is a particularly vulnerable phase, marked by loss of routine medical contact, fear of recurrence, ongoing side effects, and feelings of isolation. In breast cancer survivors, 20-40% experience clinically relevant distress, with many reporting unmet needs for psychological support. Chronic stress in cancer patients is linked to lower quality of life, worse treatment adherence, higher symptom burden, and poorer prognosis.
Acupuncture, a method from traditional Chinese medicine, has shown potential to reduce stress through modulation of the autonomic nervous system-reducing sympathetic overactivation and enhancing parasympathetic activity. It has been shown to improve symptoms such as pain, fatigue, and hot flushes in cancer patients, and to lower stress in other populations. However, there is almost no research on acupuncture's effect on post-treatment stress in breast cancer patients, especially in the critical early aftercare phase. Whether acupuncture can also improve resilience and treatment adherence in this context remains unknown.
Aim of the Study The study aims to investigate whether acupuncture reduces psychological distress in breast cancer patients who have recently completed primary therapy. Specifically, it tests whether the patients receiving acupuncture will have significantly lower perceived stress after eight weeks compared to a wait-list control group. Secondary objectives include exploring the effects of acupuncture on quality of life, fatigue, cognitive function, anxiety, depression, resilience, and therapy adherence, as well as documenting any adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, non-blinded, two-arm clinical study
| Arm | Type | Receives |
|---|---|---|
| Acupuncture: | Experimental | Procedure: Acupuncture8 sessions of acupuncture treatment, once a week |
| Wait-listed control group | Placebo comparator | Other: Standard supportive careSupportive care according to local standards will be given which may also include face-to-face psychosocial support or the participation of support groups. 8 weeks after the assessment T1 and upon completion of assessment T2, participants will receive access to 8 sessions of weekly acupuncture treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with localized breast cancer having completed primary therapy (operation +/- chemotherapy +/- radiotherapy) in the last 6 months - Distress Thermometer ≥ 5 - Age ≥ 18 years - Signed informed consent for participation of the trial
- Prior cancer is allowed
- Prior treatment - including chemotherapy - for a prior malignant tumor (including breast cancer) is allowed
- Concomitant participation in an experimental therapeutic drug trial is allowed
- Ongoing or planned Anti-her2/neu, immune checkpoint inhibitor, antihormonal and CDK4/6 inhibitor therapy or other adjuvant treatment scheduled for > 3 months during study period is allowed
Key exclusion criteria (4 listed)
- Patients with language or cognitive deficits (including impaired consciousness) that are incompatible with the participation in the study
- Severe physical or psychiatric comorbidity that prevents a patient from participating in the study
- Patients incapable of giving consent
- Pregnancy
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 |
|---|---|---|
| Acupuncture8 sessions of acupuncture treatment (body and auricular acupuncture) will be given once a week after randomization. | Procedure or surgery | Acupuncture: |
| Standard supportive careSupportive care according to local standards will be given which may also include face-to-face psychosocial support or the participation of support groups | Other | Wait-listed control group |
Primary outcome
Distress at 8 weeks of intervention
Time frame: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Distress is assessed after completion of 8 weeks of weekly acupuncture interventions or standard of care (SOC) by the Perceived Stress Scale (PSS-10). PSS-10 is a 10-item questionnaire widely used to assess stress levels in individuals. It measures the degree to which life has been perceived as unpredictable, uncontrollable und overloading over the last month. The responses are rated on a 5-point rating scale with a total score ranging from 0-40 while a higher total score indicating greater stress.
9 secondary outcomes
Distress over the course time
Time frame: Before and after each acupuncture session during the the 8 week intervention period
Quality of life assessment
Time frame: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Anxiety
Time frame: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Depression
Time frame: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Resilience
Time frame: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Therapy Adherence
Time frame: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Adverse Events:
Time frame: After each acupuncture session during the the 8 week intervention period
Fatigue
Time frame: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
Self-reported cognitive impairment
Time frame: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)
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 9 Jul 2026.
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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.
Viola Heinzelmann-Schwarz, Prof.MD study chair
University Hospital of Basel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Standard supportive care in people with Acupuncture and Breast Cancer, run by Isabell Xiang Ge at 3 sites in Switzerland.
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 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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 Isabell Xiang Ge, MD (+41 61 265 85885, isabellxiang.ge@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress at 8 weeks of intervention (time frame: Post-intervention (after completion of the 8 week acupuncture therapy or SOC)). 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 9 Jul 2026.