Stress Reduction Through Acupuncture (STREAK)

University Hospital Basel

Status: Not yet enrolling

Conditions: Breast Cancer; Survivorship; Acupuncture

Treatments: Procedure: Acupuncture; Other: Standard supportive care

Study type: Interventional

Funder types: Other

Identifiers

NCT07132034

2025-01072 bb21HeinzelmannSch3;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups, including a placebo group

Acupuncture:

Experimental group

Description:

8 sessions of acupuncture treatment, once a week

Treatment:

Procedure: Acupuncture

Wait-listed control group

Placebo Comparator 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.

Treatment:

Other: Standard supportive care