Electroacupuncture on Treating Cancer-related Depression

NCT07003763 | Recruiting

• 1 other identifier: Acupuncture Dep
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Cancer

Keywords

Electroacupuncture; cancer; depression; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale - 17 items

  The HDRS-17 is a clinician-administered scale widely used to assess the severity of depressive symptoms and evaluate treatment efficacy in clinical trials. In this study, the HDRS-17 will be administered by trained raters using structured clinical interviews. The total score ranges from 0 to 52, with higher scores indicating more severe depression. A total score \>17 is considered to reflect at least moderate depression, while a score ≤7 is typically interpreted as remission. Higher scores represent greater symptom severity.

  Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.

Secondary Outcomes (7)

• Remission Rate

  Week 12

• Response Rate

  Week 12

• Patient Health Questionnaire-9

  Baseline, Week 12, Week 24.

• Pain Rating Index

  Baseline, Week 12, and Week 24.

• Quality of Life Questionnaire for Cancer Patients

  Baseline, Week 12, and Week 24.

Study Arms (2)

Electroacupuncture group

ACTIVE COMPARATOR

Participants in the electroacupuncture group will receive treatment based on a semi-standardized acupuncture protocol, which includes six main acupoints and two supplementary acupoints selected based on individual symptom presentation.

Device: Electroacupuncture treatment; Other: Standard care

sham acupuncture group

PLACEBO COMPARATOR

Participants in the control group will receive superficial acupuncture at non-acupoint, non-meridian locations as placebo control.

Other: Superficial acupuncture at Non-Acupoints; Other: Standard care

Interventions

Standard care OTHER

All participants, regardless of group assignment, will receive standard care as part of routine oncological and psychological management. Standard care includes: * Basic psychological support: General psychological counseling or emotional support provided by nursing staff or clinical psychologists as needed, without structured psychotherapy or pharmacological antidepressant interventions unless clinically indicated. * Health education: Guidance on sleep hygiene, nutrition, and stress management, along with education about cancer-related emotional symptoms and coping strategies. * Medication management: Participants will continue their current medications for chronic comorbidities (e.g., antihypertensives, antidiabetics) as previously prescribed. However, cancer-related medications associated with active treatment-such as chemotherapy, targeted therapies, immunotherapy, or hormonal therapy-will be excluded during the trial period to avoid confounding effects.

Electroacupuncture group; sham acupuncture group

Electroacupuncture treatment DEVICE

Participants in this group will receive electroacupuncture (EA) based on a semi-standardized protocol. Each treatment session will involve needling at six main acupoints and two supplementary points, selected based on individual symptoms. * Main acupoints: Baihui (GV20), Yintang (EX-HN3), Guanyuan (CV4), Qihai (CV6), bilateral Zusanli (ST36), bilateral Sanyinjiao (SP6). * Supplementary acupoints: Selected from Shenting (GV24), Sishencong (EX-HN1), Fengchi (GB20), Neiguan (PC6), Hegu (LI4), Shenmen (HT7), Yanglingquan (GB34), Taixi (KI3), and Taichong (LR3). All patients will be placed in the supine position. After routine disinfection of all acupoints using 75% alcohol, needles will be inserted using a gentle tapping technique. Once Deqi sensation is achieved, three pairs of electrodes from an EA device will be connected to the handles of the needles at Baihui and Yintang, and bilaterally at Zusanli and Sanyinjiao. Each treatment session will last for 30 minutes.

Electroacupuncture group

Superficial acupuncture at Non-Acupoints OTHER

Participants in this group will receive superficial acupuncture at six pseudo-acupoints that do not correspond to any recognized meridian or traditional acupoint. These points are anatomically matched in location (head, upper limbs, lower limbs, and trunk) to the main acupoints used in the EA group but are located at non-meridian, non-acupoint sites in a horizontal position. Acupuncture needles will be connected to an electroacupuncture device with broken wires and thus no electrical stimulation is actually delivered. All patients will be placed in a supine position. After routine disinfection of the selected sites using 75% alcohol, sterile disposable filiform needles (0.22 × 25 mm) will be lightly inserted to a depth of approximately 3 mm without requiring deqi. The needles will be applied using a gentle tapping technique at non-meridian, non-acupoint locations. The needle will be retained for 30 minutes. The session frequency and total treatment course will match the EA group.

sham acupuncture group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Municipal Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Depression; Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Shifen Xu, Doctor

  SHMTCM's Acupuncture Department

  STUDY DIRECTOR

Central Study Contacts

Xuan Yin, Doctor

CONTACT

86-18939916330; yinxuan0623@hotmail.com

Tao Guo, Master

CONTACT

86-15047856427; guotao2000@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 4, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)