Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors

Sponsor
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study ID
NCT07481903
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Anxiety
  • Depression
  • Fatigue
  • Insomnia
  • Pain
  • Psychoneurological Symptom Cluster(Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline)
  • Subjective Cognitive Decline (SCD)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • electroacupuncture — DEVICE
    A semi-standardized protocol is used for participants in the EA group, which includes (1) standardized acupoints (Midline: Baihui \[GV20\], Shenting \[GV24\], Qihai \[CV6\], Guanyuan \[CV4\]; Bilateral: Fengchi \[GB20\], Taiyang \[EX-HN5\], Zusanli \[ST36\], Hegu \[LI4\], Taichong \[LR3\]); and (2) additional acupoints (Sishencong \[EX-HN1\] and bilateral Benshen \[GB13\] for anxiety/depression/subjective cognitive decline; 1-2 Ashi points for pain; no additional points for insomnia/fatigue). Meanwhile, electrical stimulation is conducted on three pairs of acupoints with electrode cord connection as follows: Baihui \[GV20\] and Shenting \[GV24\], left Fengchi \[GB20\] and left Taiyang \[EX-HN5\], right Fengchi \[GB20\] and right Taiyang \[EX-HN5\]. Electrical stimulation is delivered in continuous wave mode at 2 Hz with current intensity adjusted according to participant's tolerance. Electrical stimulation last 30 min. The needles on body acupoints are also retain for 30 min.
  • sham electroacupuncture — DEVICE
    In the SA group, noninsertive simulated acupuncture and sham electrical stimulation(30-second transient device activation instead of 30-minute continuous stimulation) are used, while maintaining the same treatment duration and course as the EA group. Blunt needles are placed on 12 acupoints (Bilateral: Fengchi \[GB20\], Taiyang \[EX-HN5\], Zusanli \[ST36\], Hegu \[LI4\], Taichong \[LR3\]; Midline: Qihai \[CV6\], Guanyuan \[CV4\]) without skin penetration. Electrical stimulation is conducted on two pairs of acupoints with electrode cord connection as follows: left Fengchi \[GB20\] and left Taiyang \[EX-HN5\], right Fengchi \[GB20\] and right Taiyang \[EX-HN5\]. A 2 Hz continuous wave is delivered for 30 seconds, after which the EA device is immediately turned off. The blunt needles are maintained in position for 30 minutes to match the retention time in the EA group.

Study Details

This clinical trial aims to assess whether electroacupuncture (EA) can alleviate the psychoneurological symptom cluster (including pain, fatigue, insomnia, anxiety, depression and subjective cognitive decline) in breast cancer survivors, and to evaluate the safety of this therapy. Researchers will conduct a randomized controlled trial of electroacupuncture (EA) as compared to sham electroacupuncture (SA) in breast cancer survivors with the psychoneurological symptom cluster who are currently being treated with endocrine therapy. Participants will receive 16 treatments over 8 weeks. The EA group will receive true acupuncture with continuous wave stimulation (2Hz, intensity as tolerated) administered for 30 minutes per session. The SA group will receive sham acupuncture using blunt (non-penetrating) needles that contact the skin without penetration, along with a 30-second transient device activation instead of the 30-minute continuous stimulation. Treatment outcomes for pain, fatigue, insomnia, anxiety, depression and subjective cognitive function will be assessed. The primary outcome is response rate of the psychoneurological symptom cluster after 8 weeks of treatment. Secondary outcomes include changes from baseline in the scores of each of the six psychoneurological symptoms.

Key Dates

First listed
Mar 19, 2026
Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EA group
    Participants undergo 16 sessions of electroacupuncture twice weekly over 8 weeks.
  • Sham Comparator: SA group
    Participants undergo 16 sessions of sham electroacupuncture(noninsertive simulated acupuncture and sham electrical stimulation) twice weekly over 8 weeks.

Primary Outcome Measure

Response rate of psychoneurological symptom cluster (after 8 weeks of treatment) [ Time Frame: Week 8 ]

Central Contacts

Find similar trials

Nationwide
Depression trialsInsomnia trialsPsychiatry trialsMental health trialsBehavioral health trialsSleep medicine trials

Related Studies