Clinical trial · Interventional
Stress Reduction Through Acupuncture
Study Protocol: Stress Reduction in Breast Cancer Patients During Transition Into Survivorship Using Acupuncture - a Randomized Wait-list-controlled Intervention Study
NCT07132034CI-TRIAL-00117374STREAKrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acupuncture | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Procedure | — | UNRESOLVED |
| Standard supportive care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acupuncture:
- description
- 8 sessions of acupuncture treatment, once a week
- interventionNames
- Procedure: Acupuncture
- type
- PLACEBO_COMPARATOR
- label
- Wait-listed control group
- description
- 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.
- interventionNames
- Other: Standard supportive care
Primary outcomes (1)
- measure
- Distress at 8 weeks of intervention
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * 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. Exclusion criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.