Electroacupuncture on Treating Cancer-related Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Municipal Hospital of Traditional Chinese Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Electroacupuncture treatment
DeviceParticipants 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.
Superficial acupuncture at Non-Acupoints
Other interventionParticipants 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.
Standard care
Other interventionAll 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.
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Electroacupuncture groupActive comparator 2 interventions
Group B: sham acupuncture groupPlacebo comparator 2 interventions
Trial outcomes
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.
Time frame
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.Secondary outcomes
1
Remission Rate
Proportion of participants with Hamilton Depression Rating Scale - 17 items score \<8 at Week 12.
Time frame
Week 122
Response Rate
Proportion of participants with ≥50% reduction from baseline in Hamilton Depression Rating Scale - 17 items score at Week 12.
Time frame
Week 123
Patient Health Questionnaire-9
The PHQ-9 is a self-administered instrument used to screen for depression severity and monitor treatment response. It consists of 9 items, each corresponding to DSM-5 criteria for major depressive disorder, rated on a 4-point Likert scale (0 = "not at all" to 3 = "nearly every day"). The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. Score interpretation is as follows: 5-9 = mild, 10-14 = moderate, 15-19 = moderately severe, and 20-27 = severe depression. A reduction in score over time will be used to assess treatment efficacy.
Time frame
Baseline, Week 12, Week 24.4
Pain Rating Index
The Pain Rating Index (PRI) is derived from the Short-Form McGill Pain Questionnaire (SF-MPQ) and is used to evaluate the intensity and quality of pain. It includes 15 descriptors (11 sensory and 4 affective), each rated on a 4-point scale: 0 = "none", 1 = "mild", 2 = "moderate", and 3 = "severe". The PRI is calculated by summing the scores of the individual descriptors, providing a composite measure of both sensory and affective pain dimensions. A higher PRI score indicates more severe pain experience.
Time frame
Baseline, Week 12, and Week 24.Sponsors and contacts
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Source ClinicalTrials.gov