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Trial record 4 of 4 for:    23341529 [PUBMED-IDS]

Acupuncture Prevents Chemobrain in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT02457039
Recruitment Status : Recruiting
First Posted : May 29, 2015
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Prof. Zhang Zhang-Jin, The University of Hong Kong

Brief Summary:

Chemobrain is an expression used to describe a cluster of chemotherapy-induced cognitive impairment symptoms, including problems with visual and verbal memory, forgetfulness, difficulty in learning, attention, concentration and coordination of multitasking and organization. Over 75% cancer patients experienced acute cognitive symptoms during chemotherapy and 17%-34% of them have long-term post-treatment cognitive deficits which can persist up to 10 years. Breast cancer survivors even display as high as 50%-75% prevalence of post-treatment cognitive impairment. Chemobrain has become an apparent quality-of-life issue for cancer survivors and will be encountered more frequently with the rise of the number of cancer survivors. There are no effective interventions available for preventing and treating chemobrain.

Acupuncture is beneficial in reducing various side effects of anti-cancer treatment. It also shows the efficacy in improving mild cognitive impairment and other dementia disorders; facilitates the recovery of pathological microstructural changes of the brain. These results have led to the hypothesis that acupuncture is effective in preventing chemobrain and this preventive effect may be associated with the protection against cytokine production, epigenetic modification and microstructural changes of the brain.

To test this hypothesis, an assessor-blinded, randomised controlled trial will be conducted to determine if a combination of DCEAS and body acupuncture could reduce the incidence and symptoms of chemobrain in breast cancer patients under chemotherapy compared to least acupuncture stimulation (LAS) as controls.

A total of 168 breast cancer patients who are ready for chemotherapy will be randomly assigned to comprehensive acupuncture intervention (combined DCEAS and body acupuncture regimen + chemotherapy) (CAI) (n = 84) for 2 sessions per week for 8 weeks or least acupuncture stimulation (LAS) (minimal acupuncture + chemotherapy) (n = 84). All patients receive the standard chemotherapy of breast cancer. Treatment outcomes on cognitive performance, fatigue and the depression will be assessed.


Condition or disease Intervention/treatment Phase
Chemo-brain Drug-Related Side Effects and Adverse Reactions Mild Cognitive Impairment Breast Cancer Procedure: Dense cranial electroacupuncture stimulation Procedure: Body acupuncture Procedure: Least acupuncture stimulation Drug: Cytoxan-containing chemotherapy regimens Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Assessor-Blinded, Randomised Controlled Trial of Acupuncture to Prevent Chemobrain in Breast Cancer Patients
Actual Study Start Date : October 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Comprehensive acupuncture (CAI)
Breast cancer patients receiving Cytoxan-containing chemotherapy regimens (Chemo) will receive Dense cranial electroacupuncture stimulation (DCEAS) and Body acupuncture (BA).
Procedure: Dense cranial electroacupuncture stimulation

DCEAS is a is a novel stimulation mode in which electrical stimulation is delivered on acupoints located on the forehead.

Six pairs of acupoints are used: Baihui (GV20) and Yintang (EX-HN3), left Sishencong (EX-HN1) and Toulinqi (GB15), right Sishencong (EX-HN1) and Toulinqi (GB15), bilateral Shuaigu (GB8), bilateral Taiyang (EX-HN5), and bilateral Touwei (ST8).

Disposable acupuncture needles (Hwato®, 0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation is then conducted to evoke needling sensation, followed by electrical stimulation (ITO ES-160, continuous waves at 2 Hz).

Other Name: DCEAS

Procedure: Body acupuncture

Following acupoints are used: Shui-Gou (GV26), Shen-Men (HT7). He-Gu (LI4), Wai-Guan (TE5), Zhong-Wan (CV12), Guan-Yuan (CV4), Zu-San-Li (ST36), Feng-Long (ST40) and San-Yin-Jiao (SP6).

Disposable acupuncture needles (Hwato®, 0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation is then conducted to evoke needling sensation. No electrical stimulation is delivered.

Other Name: BA

Drug: Cytoxan-containing chemotherapy regimens

Each subject shall receive oral administration or venous injection or both with adjuvant or neoadujuvant chemotherapy regimens, as decided by clinical oncologist.

In clinical practice, the most commonly used Cytoxan-containing regimens include but are not limit to:

AC (x4) [Adriamycin + Cytoxan], TC (x4) [Taxotere + Cytoxan], AC-P (4+4) [Adriamycin + Cytoxan + Paclitaxel], TAC (x6) [Taxotere + Adriamycin + Cytoxan], or AC-PH (4+4) [Adriamycin + Cytoxan + Paclitaxel + Herceptin].

Other Name: Chemo

Sham Comparator: Least acupuncture stimulation (LAS)
Breast cancer patients receiving Cytoxan-containing chemotherapy regimens (Chemo) will receive Least acupuncture stimulation (LAS)
Procedure: Least acupuncture stimulation
The acupoints chosen are less related to the treated syndromes based on Traditional Chinese Medicine (TCM) theory; the number of acupoints used and the intensity of electrical stimulation are also lower than the comprehensive acupuncture regimen. The following 6 acupoints will be used in LAS control: bilateral Tong-Tian (GB17), bilateral Shou San-Li (LI10) and bilateral Fu-Yang (BL59). Electrical stimulation will be only performed on bilateral Tong-Tian (GB17) and the intensities are adjusted to a level at which patients just start feeling the stimulation.
Other Name: LAS

Drug: Cytoxan-containing chemotherapy regimens

Each subject shall receive oral administration or venous injection or both with adjuvant or neoadujuvant chemotherapy regimens, as decided by clinical oncologist.

In clinical practice, the most commonly used Cytoxan-containing regimens include but are not limit to:

AC (x4) [Adriamycin + Cytoxan], TC (x4) [Taxotere + Cytoxan], AC-P (4+4) [Adriamycin + Cytoxan + Paclitaxel], TAC (x6) [Taxotere + Adriamycin + Cytoxan], or AC-PH (4+4) [Adriamycin + Cytoxan + Paclitaxel + Herceptin].

Other Name: Chemo




Primary Outcome Measures :
  1. Changes in cognitive function (objective measurement) [ Time Frame: Baseline, 2 week, 4 week, 6 week, 8 week ]
    The Montreal Cognitive Assessment (MoCA) of corresponding dialects will be used as an objective measurement for subjects' cognitive function. Assessments will be conducted at baseline and every 2 weeks thereafter.

  2. Changes in cognitive function (subjective measurement) [ Time Frame: Baseline, 2 week, 4 week, 6 week, 8 week ]
    The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) of corresponding dialects will be used as a subjective measurement for subjects' cognitive function. Assessments will be conducted at baseline and every 2 weeks thereafter.


Secondary Outcome Measures :
  1. Changes in quality of Life - composite measure [ Time Frame: Baseline, 4 week, 8 week ]
    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30+BR23) and Functional Assessment of Cancer Therapy-Breast (FACT-B) of corresponding dialects will be used for assessment on quality of life. Both of them will be used as the former focuses on physical function, while the latter emphasizes on emotional well-being. Assessments will be conducted at baseline and every 4 weeks thereafter.

  2. Changes in illness related fatigue measured by FACIT-Fatigue [ Time Frame: Baseline, 4 week, 8 week ]
    As fatigue is a common co-morbidity observed in patients receiving chemotherapy, it will be measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) of corresponding dialects. Assessments will be conducted at baseline and every 4 weeks thereafter.

  3. Changes in chemo adverse effects - composite measure [ Time Frame: Baseline, 4 week, 8 week ]
    Adverse side effects will be assessed using Functional Assessment of Cancer Therapy questionnaires (FACT-Taxane, FACT-BRM) of corresponding dialects. Assessments will be conducted at baseline and every 4 weeks thereafter.

  4. Changes in subject perception of chemotherapy treatment measured by FACIT-TS-G [ Time Frame: Baseline, 4 week, 8 week ]
    To determine whether acupuncture can reduce the adverse effects of chemo-therapy treatment and therefore increase subject acceptance, subject treatment satisfaction will be assessed using Functional Assessment of Chronic Illness Therapy questionnaire (FACIT-TS-G). Assessments will be conducted at baseline and every 4 weeks thereafter.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chinese females aged 18 to 65 years;
  2. have a diagnosis of stage I-IIIa breast cancer; and
  3. are ready for orally administered or vein injection or both with Cytoxan-containing regimens as adjuvant chemotherapy before or after surgical treatment or in combination with other pharmacotherapy.

Exclusion Criteria:

  1. had chemotherapy in the last 2 years;
  2. have cardiac pacemakers, epilepsy or other unstable medical conditions;
  3. had investigational drug treatment within the past 6 months;
  4. alcoholism or drug abuse within the past 1 year; or
  5. have severe needle phobia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457039


Contacts
Contact: Zhang-Jin ZHANG, MMed, PhD +852 3917 6445 zhangzj@hku.hk
Contact: Marksman MAN, BCM BSc, PhD +852 3917 6466 marksman@hku.hk

Locations
China, Guangdong
Department of Chinese Medicine, The University of Hong Kong - Shenzhen Hospital Recruiting
Shenzhen, Guangdong, China, 518053
Contact: Jun-Mei J WU, PhD, MS, MBA    +852 3917 6447    wujunmei@hku.hk   
Contact: Xian-Hui X FANG    +86 159 200 918 65    fangxh@hku-szh.org   
Principal Investigator: Jun-Mei J WU, PhD, MS, MBA         
Department of Clinical Oncology, The University of Hong Kong - Shenzhen Hospital Recruiting
Shenzhen, Guangdong, China, 518053
Contact: Victor Ho-fun V LEE, MBBS, FRCR    +852 2255 4352    vhflee@hku.hk   
Contact: Hai-Man H JING    +86 136 329 979 07    jinghm@hku-szh.org   
Principal Investigator: Victor Ho-fun V LEE, MBBS, FRCR         
Hong Kong
The Nethersole School of Nursing, The Chinese University of Hong Kong Not yet recruiting
Sha Tin, N.t., Hong Kong
Contact: Winnie Kwok-Wei SO, MHA, PhD    +852 3943 1072    winnieso@cuhk.edu.hk   
Principal Investigator: Winnie Kwok-Wei SO, MHA, PhD         
Department of Clinical Oncology, Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Tsz-Him SO, MBBS, BCM    +852 2255 4352    sth495@hku.hk   
Sub-Investigator: Victor Ho-fun LEE, MBBS, FRCR         
Principal Investigator: Tsz-Him SO, MBBS, BCM         
Department of Surgery, Queen Mary Hospital Recruiting
Hong kong, Hong Kong
Contact: Ava KWONG, PhD, FCSHK    +852 2255 4773    avakwong@hku.hk   
Principal Investigator: Ava KWONG, PhD, FCSHK         
Department of Surgery, Tung Wah Hospital Recruiting
Sai Ying Pun, Hong Kong
Contact: Ava KWONG, PhD, FCSHK    +852 2255 4773    avakwong@hku.hk   
Principal Investigator: Ava KWONG, PhD, FCSHK         
Sponsors and Collaborators
The University of Hong Kong
Chinese University of Hong Kong
Investigators
Principal Investigator: Zhang-Jin ZHANG, MMed, PhD School of Chinese Medicine, The University of Hong Kong

Publications:
Cella, D. The Functional Assessment of Chronic Illness Therapy system of Quality of Life questionnaires. Available from: http://www.facit.org/.

Responsible Party: Prof. Zhang Zhang-Jin, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02457039     History of Changes
Other Study ID Numbers: UW 14-206
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Keywords provided by Prof. Zhang Zhang-Jin, The University of Hong Kong:
Chemo-brain
Drug-Related Side Effects and Adverse Reactions
Mild Cognitive Impairment
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Cognitive Dysfunction
Drug-Related Side Effects and Adverse Reactions
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Chemically-Induced Disorders
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists