Clinical trial NCT05876988: Chinese Acupuncture for Chemobrain in Elderly Cancer Patients
Official title: The Role of Chinese Acupuncture for Chemotherapy Induced Cognitive Impairment in Elderly Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chinese Acupuncture
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Jiangsu Health Vocational College
First posted: 2023-05-26
Enrollment: 168
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

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.

Primary outcomes:
measure: Changes in score on MoCA
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: The incidences of adverse events
timeFrame: up to Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
References: