NCT07003763

Electroacupuncture on Treating Cancer-related Depression

The Effect and Safety of Electroacupuncture on Treating Cancer-related Depression: a Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression
• Cancer

Interventions

Type	Name	Description
DEVICE	Electroacupuncture treatment	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.
OTHER	Superficial acupuncture at Non-Acupoints	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.
OTHER	Standard care	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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-12-31
• Completion: 2027-07-01
• First posted: 2025-06-04
• Last updated: 2025-12-23

Locations

1 site across 1 country: China