An interventional study of Transcutaneous electrical acupoint stimulation and Sham transcutaneous electrical acupoint stimulation in Cancer Pain, Non Small Cell Lung Cancer and Bone Metastases, sponsored by The Third Affiliated hospital of Zhejiang Chinese Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by The Third Affiliated hospital of Zhejiang Chinese Medical University · Not applicable, Interventional, and Treatment
This multicenter, prospective, randomized controlled research study aims to objectively evaluate the role of transcutaneous electrical acupoint stimulation (TEAS), which combines the theory of acupuncture with transcutaneous electrical nerve stimulation (TENS) therapy, for the treatment of pain in patients with bone metastases from lung cancer.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 188 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →The Third Affiliated hospital of Zhejiang Chinese Medical University is the lead sponsor of 44 studies on the registry; 24 are open to participants now.
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A pair of conductive gel patch, connecting to the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, are respectively affixed to the ipsilateral Jiaji acupoint group (EX-B2) or the ipsilateral limb acupoint group(Hegu (LI4) - Waiguan (TE5), or Zusanli (ST36) - Sanyinjiao (SP6)), so as contralateral side. A single TEAS treatment takes 30 min. TEAS specific parameters were dilatation wave 2Hz and stimulus current intensity in degrees as tolerated by the patient. 7 days was considered as 1 session. Self-controlled treatment refers to not setting an upper limit on the number of treatment times, but must have met at least 3 days or 5 times of TEAS treatment within each session. A total of 4 sessions of treatment were administered.
Device: Transcutaneous electrical acupoint stimulation · Drug: Routine palliative treatment
Each step of the sham TEAS operation is the same as the TEAS group. A total of 4 sessions of treatment were administered. 10 free TEAS treatments will be given after the trial.
Device: Sham transcutaneous electrical acupoint stimulation · Drug: Routine palliative treatment
The patients are taken in the recumbent or sitting position, and the local skin at the acupoints is routinely disinfected. A pair of conductive gel patch, connecting to the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, are respectively affixed to the ipsilateral acupoint group, so as contralateral side.
Also known as: TEAS
The electroacupuncture instrument has a normal screen display as the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, but could not output current normally.
Also known as: sham TEAS
The patients in both groups received routine palliative treatment of tumors, such as chemotherapy, immunotherapy, targeted therapy, drug analgesic therapy, nutrition support, and so on.
The response rate of average pain in the brief pain inventory (BPI) at the end of week 4
According to the international consensus on palliative radiotherapy endpoints for bone metastasis clinical trials, the degree of therapeutic response for bone metastatic pain can be classified as complete response (CR: pain score of 0 and no increase in daily oral morphine equivalent dose (OMED) ), partial response (PR: ①pain score decrease of ≥ 2 and no increase in OMED; ②pain score no increase and decrease of ≥ 25% in OMED), pain progression (PP: ①≥ 2 increase in pain score with no decrease in OMED; ②≥ 1 increase in pain score with ≥ 25% increase in OMED) and indeterminate response (IR: cases not classified as CR / PR / PP). Subjects in which complete or partial relief of pain was achieved were pain responders; Subjects whose pain progressed or was indeterminate response were non responders. The response rate of average pain = ((CR+PR) / No. of subjects) \*100%.
Time frame: week 4
The changes of pain and inference scores in Brief Pain Inventory
Time frame: week 4, week 8, week 12
The changes of frequency of breakthrough pain within 1 week
Time frame: week 4, week 8, week 12
The changes of OMED on assessment days
The daily oral morphine equivalent dose over the past 24 h will be recorded for both groups at each testing time point. Equivalent morphine dose conversions will be established in accordance with the NCCN clinical practice guidelines for adult cancer pain (version 3.2022). For instance, fentanyl transdermal patch (25 mcg/h) will be considered approximately equal to oxycodone (30 mg/d), parenteral morphine (20 mg/d), and oral morphine (60 mg/d).
Time frame: week 4, week 8, week 12
Quality of life measured by EORTC QLQ-C30 score
The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) is an integrated system for assessing the quality of life (QoL) of cancer patients. The EORTC QLQ-C30 incorporates nine multi-item scales: five functional scales (Physical, Role, Cognitive, Emotional and Social Functioning); three symptom scales (Fatigue, Pain and Nausea/Vomiting); and a Global Health Status/QoL scale. Six single item scales are also included (Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrhoea and Financial Difficulties). Scale scores were calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Time frame: week 4, week 8, week 12
The changes in mood scale scores of Hamilton Rating Scale for Depression (HAM-D)
HAM-D is a standardized scale for the measurement of the severity of depressive symptoms, initially designed to yield a total score based on 17 items. The scores of anxiety/depression and its change during the previous 2 weeks from baseline will be recorded.The total score \> 24 points, severe depression. 17≤ score ≤24, moderate depression. 7≤ score ≤17, mild depression. \< 7 points, no depressive symptoms.
Time frame: week 4, week 8, week 12
The changes in mood scale scores of Hamilton Rating Scale for Hamilton Rating Scale for Anxiety (HAM-A)
HAM-A is one of the most widely used rating scales to measure the severity of perceived anxiety symptoms. A total of 14 items were included 14 items. The total score ≥29 points, may be severe anxiety. ≥21 points, there must be obvious anxiety. ≥14 points, must have anxiety. ≥7 points, may have anxiety. \< 7 points, no anxiety symptoms.
Time frame: week 4, week 8, week 12
The changes of tri-lineage cell counts in blood
Time frame: week 4, week 8, week 12
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Plan to share: No
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The Third Affiliated hospital of Zhejiang Chinese Medical University