Clinical trial NCT07003763: Electroacupuncture on Treating Cancer-related Depression
Official title: The Effect and Safety of Electroacupuncture on Treating Cancer-related Depression: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Cancer
Keywords: Electroacupuncture
cancer
depression
randomized controlled trial
Lead sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cancer-related depression (CRD) is a common psychological condition among cancer patients during diagnosis, treatment, and recovery, and is associated with reduced quality of life, impaired immune function, and poorer clinical outcomes. As cancer incidence and mortality continue to rise in China, the psychological burden on patients is receiving increasing attention. Electroacupuncture (EA) has shown potential in treating various types of depression and related somatic symptoms, but evidence regarding its efficacy, safety, and long-term effects in CRD remains limited. This randomized controlled trial aims to evaluate the short- and long-term efficacy and safety of EA for CRD, with the goal of providing evidence to support effective and optimized treatment strategies.

Detailed description: Cancer-related depression (CRD) is a prevalent and complex comorbidity among cancer patients, often arising during diagnosis, treatment, or disease progression. It is associated with a range of psychological and somatic symptoms that significantly reduce quality of life, compromise treatment adherence, and may negatively affect clinical outcomes and overall survival. As cancer incidence and mortality continue to rise in China's aging population, addressing the emotional and psychological burden of cancer has become increasingly important.

Current treatments for CRD largely rely on pharmacological interventions, particularly selective serotonin reuptake inhibitors (SSRIs). However, these medications often have delayed onset, potential side effects, and limited tolerability in patients undergoing cancer treatment. These limitations highlight the need for safe, non-pharmacological alternatives that can effectively alleviate depressive symptoms in this vulnerable population.

Acupuncture, a traditional Chinese medical therapy, has been widely used for managing depressive disorders and cancer-related symptoms. Electroacupuncture (EA), which combines needling with electrical stimulation, has demonstrated therapeutic potential in preliminary studies for depression and symptom relief in cancer patients. Despite encouraging results, the overall quality of evidence remains low, and rigorous randomized controlled trials (RCTs) focusing specifically on CRD are still lacking.

This study aims to evaluate the efficacy and safety of electroacupuncture in the treatment of CRD through a well-designed, randomized, assessor-blinded controlled trial. The trial will assess both short-term and long-term outcomes in patients with clinically diagnosed CRD, using validated measures for depression severity, quality of life, and symptom burden. Participants will be randomly assigned to either an intervention or control group, and all participants will continue to receive routine care during the study.

The results of this trial will contribute to the growing body of evidence on integrative approaches in cancer care. It aims to determine whether EA can serve as a safe and effective adjunct to conventional cancer treatment, improve patients' emotional well-being, and support a more holistic model of care. This research also aligns with national health strategies promoting integrative medicine and may inform future clinical guidelines for managing psychological distress in cancer populations.

Eligibility criteria: Inclusion Criteria:

1. Presence of depression attributed to cancer itself or cancer-related treatments, meeting the diagnostic criteria for depressive disorder（DSM-V).
2. Age between 18 and 75 years, regardless of sex.
3. Hamilton Depression Rating Scale-17 (HDRS-17) total score \>17 at baseline.
4. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
5. No previous exposure to acupuncture treatment.
6. Ability to understand the study procedures and willingness to provide written informed consent.

Exclusion Criteria:

1. Planned to undergo surgery, chemotherapy, radiotherapy, immunotherapy, or other active cancer-related treatments during the study period.
2. History of major depressive episodes prior to cancer diagnosis.
3. Pain Rating Index (PRI) score ≥4 due to cancer-related pain.
4. Estimated life expectancy of 12 months or less.
5. Presence of severe ulcers, abscesses, or active skin infections at or near the acupuncture sites.
6. Clinically significant dysfunction of major organs, including severe cardiac, cerebral, hepatic, renal impairment; decompensated pulmonary disease; or other serious systemic illnesses.
7. Pregnant or breastfeeding women.
8. Participation in another clinical trial within the past 30 days.

Primary outcomes:
measure: Hamilton Depression Rating Scale - 17 items
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.
Secondary outcomes:
measure: Remission Rate
timeFrame: Week 12
measure: Response Rate
timeFrame: Week 12
measure: Patient Health Questionnaire-9
timeFrame: Baseline, Week 12, Week 24.
measure: Pain Rating Index
timeFrame: Baseline, Week 12, and Week 24.
measure: Quality of Life Questionnaire for Cancer Patients
timeFrame: Baseline, Week 12, and Week 24.
measure: Use of Antidepressants
timeFrame: Baseline, and Week 12.
measure: Treatment Emergent Symptom Scale (TESS)
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
Study officials:
affiliation: SHMTCM's Acupuncture Department
name: Shifen Xu, Doctor
role: STUDY_DIRECTOR
References: