Chinese AcupunctureNCT05876988
Chinese Acupuncture for Chemobrain in Elderly Cancer Patients
A study testing Chinese acupuncture in people with Chinese Acupuncture, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chinese Acupuncture
- What is being tested?
- Chinese acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly cancer patients >60 years old;
- Patients clinically confirmed with malignant tumor ;
- Chemotherapy related cognitive impairment anticipated.
Who cannot join
- Chemotherapy received in the past two years;
- Implanted pacemaker in the body and epilepsy or other unstable diseases.
- Participated in drug research within the past six years;
- Alcohol or drug abuse in the past years;
- Fear of needles;
- History of stroke or head trauma;
- Have a history of mood disorders or mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Yongling Gong, +8618915953828
About this study
Official title: The Role of Chinese Acupuncture for Chemotherapy Induced Cognitive Impairment in Elderly Cancer Patients
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.
Read the 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 Board(IRB) 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 Assessment(MoCA) 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 Anorexia/Cachexia 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.
- Conditions
- Chinese Acupuncture
- Being tested
- Chinese acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese acupunctureDevice
Disposable acupuncture needles(0.30mm in diameter and 25-40mm in length) will be inserted at a depth of 10-30mm perpendicularly or obliquely into acupoints. Manual manipulation will be carried out for all acupoints to evoke needling sensation. Electrical stimulation was additionally delivered on the 6 pairs of the frontal acupoints. The output peak current and voltage of the machine would be 6V and 48mA, respectively, with constant wave at frequency of 2Hz and phase duration of 100µs for 30min. Electrical stimulation lasted 30min. The needles on body acupoints will be also retained for 30min.
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Electroacupuncture intervention will take about 45 minutes every time. For experimental group, acupuncture points are mainly in the head, limbs and abdomen, and a total of six pairs of electric acupuncture for head. The Montreal Cognitive Assessment (MoCA) serves as the primary outcome. Digit span test will be the secondary outcome for 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). 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. Receives: Device: Chinese acupuncture |
| control group | Placebo comparator | Electroacupuncture intervention will take about 45 minutes every time. For the control group, acupuncture points are mainly on the head and limbs, only a pair of electric needles for head. The Montreal Cognitive Assessment (MoCA) serves 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. Receives: Device: Chinese acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in score on MoCA
The primary outcome will be measured using the Montreal Cognitive Assessment(MoCA)
Measured: Baseline, Week 2, Week 4, Week 6, Week 8
The incidences of adverse events
The incidences of adverse events
Measured: up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start30 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chinese AcupunctureStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Health Vocational College
- Responsible party
- Principal investigator, Gong yongling,MD, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876988
- Sponsor's protocol ID
- Nanjing First
- Status last verified
- Oct 2023
- First submitted
- 13 Apr 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao S, Zhang J, Wan H, Tao C, Hu M, Liang W, Xu Z, Xu B, Zhang J, Wang G, Li P, Lyu G, Gong Y. Role of Chinese Acupuncture in the Treatment for Chemotherapy-Induced Cognitive Impairment in Older Patients With Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 8;13:e53853. doi: 10.2196/53853.
PubMed 38329790
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Chinese Acupuncture for Chemotherapy Induced Cognitive Impairment in Elderly Cancer Patients
- ClinicalTrials.gov ID
- NCT05876988
- Acronym / sponsor ID
- Nanjing First
- Conditions
- Chinese Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Health Vocational College
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Board(IRB) 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 Assessment(MoCA) 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 Anorexia/Cachexia 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Chinese acupunctureElectroacupuncture intervention will take about 45 minutes every time. For experimental group, acupuncture points are mainly in the head, limbs and abdomen, and a total of six pairs of electric acupuncture for head. The Montreal Cognitive Assessment (MoCA) serves as the primary outcome. Digit span test will be the secondary outcome for 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). 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. |
| control group | Placebo comparator | Device: Chinese acupunctureElectroacupuncture intervention will take about 45 minutes every time. For the control group, acupuncture points are mainly on the head and limbs, only a pair of electric needles for head. The Montreal Cognitive Assessment (MoCA) serves 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elderly cancer patients >60 years old;
- Patients clinically confirmed with malignant tumor ;
- Chemotherapy related cognitive impairment anticipated.
Key exclusion criteria (7 listed)
- Chemotherapy received in the past two years;
- Implanted pacemaker in the body and epilepsy or other unstable diseases.
- Participated in drug research within the past six years;
- Alcohol or drug abuse in the past years;
- Fear of needles;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese acupunctureDisposable acupuncture needles(0.30mm in diameter and 25-40mm in length) will be inserted at a depth of 10-30mm perpendicularly or obliquely into acupoints. Manual manipulation will be carried out for all acupoints to evoke needling sensation. Electrical stimulation was additionally delivered on the 6 pairs of the frontal acupoints. The output peak current and voltage of the machine would be 6V and 48mA, respectively, with constant wave at frequency of 2Hz and phase duration of 100µs for 30min. Electrical stimulation lasted 30min. The needles on body acupoints will be also retained for 30min. 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. | Device | control group, experimental group |
Primary outcome
Changes in score on MoCA
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
The primary outcome will be measured using the Montreal Cognitive Assessment(MoCA)
The incidences of adverse events
Time frame: up to Week 8
The incidences of adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Derived from this study: PubMed 38329790Zhao S, Zhang J, Wan H, Tao C, Hu M, Liang W, Xu Z, Xu B, Zhang J, Wang G, Li P, Lyu G, Gong Y. Role of Chinese Acupuncture in the Treatment for Chemotherapy-Induced Cognitive Impairment in Older Patients With Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 8;13:e53853. doi: 10.2196/53853.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese acupuncture in people with Chinese Acupuncture, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongling Gong, doctor (+8618915953828 ext. 66243, gongyongling26@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in score on MoCA (time frame: Baseline, Week 2, Week 4, Week 6, Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05876988, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.