Chinese Acupuncture for Chemobrain in Elderly Cancer Patients

Trial Title: Chinese Acupuncture for Chemobrain in Elderly Cancer Patients

NCT ID: NCT05876988

Condition: Chinese Acupuncture

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: Chinese acupuncture
Description: 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.
Arm group label: control group
Arm group label: experimental group

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.

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Elderly cancer patients >60 years old; 2. Patients clinically confirmed with malignant tumor ; 3. Chemotherapy related cognitive impairment anticipated. Exclusion Criteria: 1. Chemotherapy received in the past two years; 2. Implanted pacemaker in the body and epilepsy or other unstable diseases. 3. Participated in drug research within the past six years; 4. Alcohol or drug abuse in the past years; 5. Fear of needles; 6. History of stroke or head trauma; 7. Have a history of mood disorders or mental illness.

Gender: All

Minimum age: 60 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Nanjing First Hospital

Address:
City: Nanjing
Zip: 210006
Country: China

Status: Recruiting

Contact:
Last name: Yongling Gong

Phone: +8618915953828

Start date: September 30, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: Nanjing First Hospital, Nanjing Medical University
Agency class: Other

Collaborator:
Agency: Jiangsu Health Vocational College
Agency class: Other

Source: Nanjing First Hospital, Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05876988