The Effect of Patient-Controlled TEAS vs Sham TEAS for Improve Quality of Life in Patients With Cancer Pain

Cancer Pain Clinical Trial

Official title:

Patient-Controlled Transcutaneous Acupoint Electrical Stimulation to Improve Quality of Life in Patients With Cancer Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06188286
• Other study ID #: 0593
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled clinical pilot study to evaluate the evidence-based basis for transcutaneous acupoint electrical stimulation to improve the quality of life of patients with cancer pain。

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

(1)18 years old= = 85 years old. (2)Meet the latest 2022 American Cancer Society definition and diagnosis of malignancy.Criterion of diagnosis, pathological and/or cytological diagnosis of primary or secondary malignancy.

(3)Presence of cancer-related pain, average NRS pain score of =1 in the previous 1 week, or regular use of analgesics.

(4)Estimated survival = 3 months. (5)Karnofsky performance status scale (KPS) score = 60 or ECOG-PS score =2 points.

Stable vital signs, clear consciousness, and the ability to correctly judge their pain, Communication is unhindered. Able to cooperate with researchers to complete relevant research assessments.

(6)Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

1. The pain is not related to cancer.

2. Have venous thrombosis of the upper and lower limbs (below the elbow/knee joint), active cerebrovascular disease, severe cardiopulmonary dysfunction or People with respiratory depression.

3. Patients with pacemaker implantation or metal implantation in the body.

4. People who have skin lesions, poor skin conditions, or other people who are not suitable for PC-TEAS treatment.

5. Cancer patients who are planning to become pregnant recently or are pregnant.

6. Have a psychiatric disorder or have severe cognitive impairment.

7. Those who are participating in other clinical trials that affect the evaluation of the results of this study.

Related Conditions & MeSH terms

• Cancer Pain

Intervention

Other:
• Transcutaneous electrical acupoint stimulation
The 4 patches of the transcutaneous acupoint electrical stimulator were pasted on two pairs of acupuncture points, the output frequency was adjusted to 2Hz, the intensity was up to 50ma, the single intervention time was 30 minutes, and another group of acupuncture points was replaced after completion, and the rest of the operations were the same as above, with a total intervention time of 1 hour.
• sham Transcutaneous electrical acupoint stimulation
The patch is fixed on the acupuncture point to turn on the instrument, but there is no current output

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yi Liang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the changes of EORTC QLQ-C30 overall health score from baseline	The European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC QLQ-C30) is a specific scale for the quality of life of cancer patients and contains 30 questions. Overall health contains 2 questions and standardized scores with values ranging from 0 to 100. Higher scores indicate a better quality of life.	week 4
Secondary	the changes of KPS score from baseline	Karnofsky's performance status is a scale for evaluating the quality of life of patients. Scores range from 0 to 100, with higher scores indicating a better quality of life.	week 4, week 8, week 12
Secondary	the changes in BPI score of mean pain, severe Pain, least pain and current pain from baesline	Brief Pain Inventory (BPI) scale is a commonly used scale for evaluating pain. Assess the patient's mean pain, severe pain, least pain score over the past week, and current level of pain. Scores range from 1-10, with higher scores indicating more severe pain.	week 4, week 8, week 12
Secondary	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).	week 4, week 8, week 12
Secondary	Index of spontaneous bowel movements	Spontaneous bowel movements (SBM) refer to bowel movements that have occurred within the past 24 hours without the use of laxatives.Record the number of spontaneous bowel movements of the subject in the past week. Bowel Function Index (BFI) in clinical practice. Specially used to evaluate constipation caused by opioid drugs, the subject's difficulty in defecation and feeling of incomplete defecation in the past week will be recorded. The overall satisfaction rating of defecation.	week 4, week 8, week 12
Secondary	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.	week 4, week 8, week 12
Secondary	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.	week 4, week 8, week 12
Secondary	The changes of tri-lineage cell counts in blood		week 4, week 8, week 12
Secondary	the changes of EORTC QLQ-C30 functional scores from baseline	The European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC QLQ-C30) is a specific scale for the quality of life of cancer patients and contains 30 questions. Standardized scores with values ranging from 0 to 100. It 5 functional subscales including body, function, cognition, emotion, and Society. Functional subscales have higher scores with better health.	week 4,week 8, week 12
Secondary	the changes of EORTC QLQ-C30 symptom scores from baseline	The European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC QLQ-C30) is a specific scale for the quality of life of cancer patients and contains 30 questions. Standardized scores with values ranging from 0 to 100. Symptom subscales including fatigue, pain, nausea, vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and economic difficulties. Symptom higher scores with worse health.	week 4,week 8, week 12