Stress Reduction Through Acupuncture

NCT07132034 | Not Yet Recruiting DMC

• 1 other identifier: 2025-01072;bb21HeinzelmannSch3
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acupuncture; Breast Cancer; Survivorship

Keywords

Integrative Oncology; Acupuncture; Breast Cancer; Survivorship; Distress

Outcome Measures

Primary Outcomes (1)

• 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.

  Post-intervention (after completion of the 8 week acupuncture therapy or SOC)

Secondary Outcomes (9)

• Distress over the course time

  Before and after each acupuncture session during the the 8 week intervention period

• Quality of life assessment

  Post-intervention (after completion of the 8 week acupuncture therapy or SOC)

• Anxiety

  Post-intervention (after completion of the 8 week acupuncture therapy or SOC)

• Depression

  Post-intervention (after completion of the 8 week acupuncture therapy or SOC)

• Resilience

  Post-intervention (after completion of the 8 week acupuncture therapy or SOC)

Study Arms (2)

Acupuncture:

EXPERIMENTAL

8 sessions of acupuncture treatment, once a week

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.

Other: Standard supportive care

Interventions

Acupuncture PROCEDURE

8 sessions of acupuncture treatment (body and auricular acupuncture) will be given once a week after randomization.

Acupuncture:

Standard supportive care OTHER

Supportive care according to local standards will be given which may also include face-to-face psychosocial support or the participation of support groups

Wait-listed control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Viola Heinzelmann-Schwarz, Prof.MD

  University Hospital of Basel

  STUDY CHAIR

Central Study Contacts

Isabell Xiang Ge, MD

CONTACT

+41 61 265 85885; isabellxiang.ge@usb.ch

Christian Kurzeder, Prof.MD

CONTACT

+41 61 32 87990; christian.kurzeder@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, non-blinded, two-arm clinical study

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 20, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

CH (1)