Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05876988
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2023-04-13
Brief Title:
Chinese Acupuncture for Chemobrain in Elderly Cancer Patients
Sponsor:
Nanjing First Hospital Nanjing Medical University
Organization:
Nanjing First Hospital Nanjing Medical University
Study Overview
Official Title:
The Role of Chinese Acupuncture for Chemotherapy Induced Cognitive Impairment in Elderly Cancer Patients
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Elderly cancer patients would suffer cognitive impairment due to chemotherapy and a series of neurocognitive symptoms known as chemobrain Chinese acupuncture plus herbal decoctions is an emerging therapeutic option for chemotherapy induced cognitive impairment in elderly cancer patients despite limited supporting evidence By evaluating this novel Chinese medicine mode in elderly cancer patients at our institution the investigators aim to contribute to the existing knowledge in this area while establishing a basis for further research
The investigators will perform a study of all cases of chemobrain related elderly cancer patients treated with Chinese acupuncture from 2023 to 2025 The investigators would enroll 168 elderly cancer patients with clinically confirmed chemobrain those for Chinese acupuncture will be treated with electroacupuncture 2 sessions per week over 8 weeks the others will be received conventional drug therapy or palliative-intent therapy The Montreal Cognitive Assessment MoCA will be served as the primary outcome Digit span test will be the secondary outcome for attentional function and working memory The quality of life and multiple functional assessments will also be evaluated
The investigators will perform a study of all cases of chemobrain related elderly cancer patients treated with Chinese acupuncture from 2023 to 2025 The investigators would enroll 168 elderly cancer patients with clinically confirmed chemobrain those for Chinese acupuncture will be treated with electroacupuncture 2 sessions per week over 8 weeks the others will be received conventional drug therapy or palliative-intent therapy The Montreal Cognitive Assessment MoCA will be served as the primary outcome Digit span test will be the secondary outcome for attentional function and working memory The quality of life and multiple functional assessments will also be evaluated
Detailed Description:
Elderly cancer patients would suffer cognitive impairment due to chemotherapy and a series of neurocognitive symptoms known as chemobrain Chinese acupuncture plus herbal decoctions is an emerging therapeutic option for chemotherapy-induced cognitive impairment in elderly cancer patients despite limited supporting evidence By evaluating this novel Chinese medicine mode in elderly cancer patients at our institution the investigators would like to contribute to the existing knowledge in this area while establishing a basis for further research
This randomized controlled trial would be conducted from Jan 2023 to December 2025 in clinics of Nanjing 1st Hospital Nanjing China Potentially eligible patients will be recruited through clinical oncologists referral from local hospital and advertisement The study protocol should be approved by Institutional Review BoardIRB of the Nanjing 1st Hospital The investigators will enroll 168 elderly cancer patients with clinically confirmed chemobrain
Acupuncture intervention will be conducted for 2 sessions per week over 8 consecutive weeks The determination of 8 weeks of the treatment duration will be based on the fact that the robust effects of acupuncture in cancer patients will be generally observed within 8 weeks of treatment
The primary outcome will be measured using the Montreal Cognitive AssessmentMoCA which has been extensively used in the study of cognitive disorders The forward and reverse digit span test would serve the secondary outcomes to detect attentional function and working memory In addition EORTCQLQ-C30 will be used to examine the quality of life of elderly cancer patients Functional changes and side effects associated with therapies will be measured using the Functional Assessment of Cancer Therapy FACT Functional Assessment of Chronic Illness Therapy FACIT Functional Assessment of AnorexiaCachexia Therapy FAACT Functional Assessment of Cancer Therapy-Taxane FACT-Taxane and Functional Assessment of Cancer Therapy-Biologic Response Modifier FACT-BRM These instruments have been widely used in elderly cancer patients Most items of these functional assessments are 5-point Likert scale questions Functional items which would be rated as 3 quite a bit or higher and incidences would be significantly different between the two groups in any assessment point will be extracted for statistical analysis
This randomized controlled trial would be conducted from Jan 2023 to December 2025 in clinics of Nanjing 1st Hospital Nanjing China Potentially eligible patients will be recruited through clinical oncologists referral from local hospital and advertisement The study protocol should be approved by Institutional Review BoardIRB of the Nanjing 1st Hospital The investigators will enroll 168 elderly cancer patients with clinically confirmed chemobrain
Acupuncture intervention will be conducted for 2 sessions per week over 8 consecutive weeks The determination of 8 weeks of the treatment duration will be based on the fact that the robust effects of acupuncture in cancer patients will be generally observed within 8 weeks of treatment
The primary outcome will be measured using the Montreal Cognitive AssessmentMoCA which has been extensively used in the study of cognitive disorders The forward and reverse digit span test would serve the secondary outcomes to detect attentional function and working memory In addition EORTCQLQ-C30 will be used to examine the quality of life of elderly cancer patients Functional changes and side effects associated with therapies will be measured using the Functional Assessment of Cancer Therapy FACT Functional Assessment of Chronic Illness Therapy FACIT Functional Assessment of AnorexiaCachexia Therapy FAACT Functional Assessment of Cancer Therapy-Taxane FACT-Taxane and Functional Assessment of Cancer Therapy-Biologic Response Modifier FACT-BRM These instruments have been widely used in elderly cancer patients Most items of these functional assessments are 5-point Likert scale questions Functional items which would be rated as 3 quite a bit or higher and incidences would be significantly different between the two groups in any assessment point will be extracted for statistical analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None