Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Ovarian Neoplasms

Pain

Pelvic Pain

Endometriosis

Uterine Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neurologic Manifestations

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Diseases

Ovarian Cancer

Chinese Acupuncture

Peter Wayne, PhD

The purpose of this study is to evaluate the safety and effectiveness of acupuncture in treating women's health conditions.

This trial comprises three studies. In the first two studies, women will be randomly assigned to receive either real or sham acupuncture therapy. Study 1 will include women with various forms of cancer. White blood cell counts will be used to assess the effects of acupuncture on participants' immune responses. Study 2 will include women with unspecified pelvic pain and endometriosis; a self-report pain scale will be used to assess the effects of acupuncture on participants' symptoms. Study 3 will evaluate the validity and reliability of diagnoses made by Chinese medicine practitioners. In this study, a group of Chinese medicine practitioners will diagnose the same group of patients; consistency of the diagnoses will be evaluated.

Acupuncture for Women's Health Conditions

New England School of Acupuncture (NESA) Acupuncture Research Collaborative

National Center for Complementary and Integrative Health (NCCIH)

Behaviors and Mental Disorders

Substance Related Disorders

Cognitive Dysfunction

Chemotherapy-Related Cognitive Impairment

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.

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.

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.

Chinese acupuncture

Yongling Gong, doctor

Yongling Gong

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.

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.

Chinese Acupuncture for Chemobrain in Elderly Cancer Patients

The Role of Chinese Acupuncture for Chemotherapy Induced Cognitive Impairment in Elderly Cancer Patients

The primary outcome will be measured using the Montreal Cognitive Assessment(MoCA)

Jiangsu Health Vocational College

Nanjing First Hospital, Nanjing Medical University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Acupuncture for Women's Health Conditions	NCT00090389	Ovarian Neoplas... Endometriosis Pelvic Pain Uterine Neoplas...	Chinese Acupunc...	18 Years -	National Center for Complementary and Integrative Health (NCCIH)
Acupuncture for Women's Health Conditions	NCT00090389	Ovarian Neoplas... Endometriosis Pelvic Pain Uterine Neoplas...	Chinese Acupunc...	18 Years -	National Center for Complementary and Integrative Health (NCCIH)
Chinese Acupuncture for Chemobrain in Elderly Cancer Patients	NCT05876988	Chinese Acupunc...	Chinese acupunc...	60 Years -	Nanjing First Hospital, Nanjing Medical University

Spots Global Cancer Trial Database for chinese acupuncture