Back to resultsTEAS for the Treatment of Pain in Bone Metastases of Lung Cancer
Primary Purpose
Cancer Pain, Non Small Cell Lung Cancer, Bone Metastases
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous electrical acupoint stimulation
Sham transcutaneous electrical acupoint stimulation
Routine palliative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Pain focused on measuring transcutaneous electrical nerve stimulation, Transcutaneous electrical acupoint stimulation
Eligibility Criteria
Inclusion Criteria: Fulfilled the diagnostic criteria of non-small cell lung cancer and had a diagnosis of definite bone-metastatic-related pain. Potent opioid analgesics have been prescribed regularly. Bone protective agents (bisphosphonates or desumumab) have been used regularly. Expected survival ≥ 3 months with no obvious contraindication to opioid therapy. Stable vital signs and ECOG-PS score ≤ 2 points; able to cooperate with researchers to complete relevant study evaluations. Signed informed consent. Exclusion Criteria: Definitively diagnosed with pain unrelated to lung cancer. Received local radiation therapy or surgery targeting bone metastases within 1 week before enrollment or will receive during the intervention period. The surgery including vertebroplasty, radioparticle implantation, neurological lesions, and other minimally invasive interventions. Venous thrombosis in the upper and lower extremities (below the elbow / knee joint), active cerebrovascular disease, severe cardiopulmonary dysfunction, or those with respiratory depression. Pacemaker implantation or metallic implants in vivo. Skin lesions at the acupoints, poor skin condition, or other situations that are not suitable for treatment with TEAS. Opioid hypersensitivity. Psychiatric disorders or severe cognitive deficits. Participating in other clinical trialists influencing the evaluation of the results of this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
true TEAS
sham TEAS
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
The changes of pain and inference scores in Brief Pain Inventory
The changes of frequency of breakthrough pain within 1 week
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).
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.
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.
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.
The changes of tri-lineage cell counts in blood
Full Information
NCT ID
NCT05730972
First Posted
January 28, 2023
Last Updated
September 21, 2023
Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05730972
Brief Title
TEAS for the Treatment of Pain in Bone Metastases of Lung Cancer
Official Title
Transcutaneous Electrical Acupoint Stimulation (TEAS) for the Treatment of Pain in Bone Metastases of Lung Cancer: A Multicenter Prospective RCT Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 10, 2023 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain, Non Small Cell Lung Cancer, Bone Metastases, Acupuncture
Keywords
transcutaneous electrical nerve stimulation, Transcutaneous electrical acupoint stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
true TEAS
Arm Type
Experimental
Arm Description
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.
Arm Title
sham TEAS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical acupoint stimulation
Other Intervention Name(s)
TEAS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham transcutaneous electrical acupoint stimulation
Other Intervention Name(s)
sham TEAS
Intervention Description
The electroacupuncture instrument has a normal screen display as the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, but could not output current normally.
Intervention Type
Drug
Intervention Name(s)
Routine palliative treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
The response rate of average pain in the brief pain inventory (BPI) at the end of week 4
Description
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
Secondary Outcome Measure Information:
Title
The changes of pain and inference scores in Brief Pain Inventory
Time Frame
week 4, week 8, week 12
Title
The changes of frequency of breakthrough pain within 1 week
Time Frame
week 4, week 8, week 12
Title
The changes of OMED on assessment days
Description
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
Title
Quality of life measured by EORTC QLQ-C30 score
Description
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
Title
The changes in mood scale scores of Hamilton Rating Scale for Depression (HAM-D)
Description
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
Title
The changes in mood scale scores of Hamilton Rating Scale for Hamilton Rating Scale for Anxiety (HAM-A)
Description
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
Title
The changes of tri-lineage cell counts in blood
Time Frame
week 4, week 8, week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fulfilled the diagnostic criteria of non-small cell lung cancer and had a diagnosis of definite bone-metastatic-related pain.
Potent opioid analgesics have been prescribed regularly.
Bone protective agents (bisphosphonates or desumumab) have been used regularly.
Expected survival ≥ 3 months with no obvious contraindication to opioid therapy.
Stable vital signs and ECOG-PS score ≤ 2 points; able to cooperate with researchers to complete relevant study evaluations.
Signed informed consent.
Exclusion Criteria:
Definitively diagnosed with pain unrelated to lung cancer.
Received local radiation therapy or surgery targeting bone metastases within 1 week before enrollment or will receive during the intervention period. The surgery including vertebroplasty, radioparticle implantation, neurological lesions, and other minimally invasive interventions.
Venous thrombosis in the upper and lower extremities (below the elbow / knee joint), active cerebrovascular disease, severe cardiopulmonary dysfunction, or those with respiratory depression.
Pacemaker implantation or metallic implants in vivo.
Skin lesions at the acupoints, poor skin condition, or other situations that are not suitable for treatment with TEAS.
Opioid hypersensitivity.
Psychiatric disorders or severe cognitive deficits.
Participating in other clinical trialists influencing the evaluation of the results of this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Liang, PhD
Phone
86-571-86633328
Email
liangyiwww@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhengyi Lyu, PhD
Email
202211011211030@zcmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Liang, PhD
Organizational Affiliation
Zhejiang Chinese Medical University, China
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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TEAS for the Treatment of Pain in Bone Metastases of Lung Cancer
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