Acupuncture Prevents Chemobrain in Breast Cancer Patients

NCT02457039 | Completed

• 1 other identifier: UW 14-206
• Study Type: interventional
• Target: 93
• Locations: 2 countries
• Sites: 6

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.

Conditions

Chemo-brain; Drug-Related Side Effects and Adverse Reactions; Mild Cognitive Impairment; Breast Cancer

Keywords

Chemo-brain; Drug-Related Side Effects and Adverse Reactions; Mild Cognitive Impairment; Breast cancer

Outcome Measures

Primary Outcomes (2)

• Changes in cognitive function (objective measurement)

  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.

  Baseline, 2 week, 4 week, 6 week, 8 week

• Changes in cognitive function (subjective measurement)

  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.

  Baseline, 2 week, 4 week, 6 week, 8 week

Secondary Outcomes (4)

• Changes in quality of Life - composite measure

  Baseline, 4 week, 8 week

• Changes in illness related fatigue measured by FACIT-Fatigue

  Baseline, 4 week, 8 week

• Changes in chemo adverse effects - composite measure

  Baseline, 4 week, 8 week

• Changes in subject perception of chemotherapy treatment measured by FACIT-TS-G

  Baseline, 4 week, 8 week

Study Arms (2)

Comprehensive acupuncture (CAI)

ACTIVE COMPARATOR

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; Procedure: Body acupuncture; Drug: Cytoxan-containing chemotherapy regimens

Least acupuncture stimulation (LAS)

SHAM COMPARATOR

Breast cancer patients receiving Cytoxan-containing chemotherapy regimens (Chemo) will receive Least acupuncture stimulation (LAS)

Procedure: Least acupuncture stimulation; Drug: Cytoxan-containing chemotherapy regimens

Interventions

Dense cranial electroacupuncture stimulation PROCEDURE

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).

Also known as: DCEAS

Comprehensive acupuncture (CAI)

Body acupuncture PROCEDURE

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.

Also known as: BA

Comprehensive acupuncture (CAI)

Least acupuncture stimulation PROCEDURE

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.

Also known as: LAS

Least acupuncture stimulation (LAS)

Cytoxan-containing chemotherapy regimens DRUG

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) \[Adriamycin + Cytoxan + Paclitaxel + Herceptin\].

Also known as: Chemo

Comprehensive acupuncture (CAI); Least acupuncture stimulation (LAS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese females aged 18 to 65 years;
• have a diagnosis of stage I-IIIa breast cancer; and
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator

Study Sites (6)

Department of Chinese Medicine, The University of Hong Kong - Shenzhen Hospital

Shenzhen, Guangdong, 518053, China

Location

Department of Clinical Oncology, The University of Hong Kong - Shenzhen Hospital

Shenzhen, Guangdong, 518053, China

Location

The Nethersole School of Nursing, The Chinese University of Hong Kong

Shatin, N.T., Hong Kong

Location

Department of Clinical Oncology, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Department of Surgery, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Department of Surgery, Tung Wah Hospital

Sai Ying Pun, Hong Kong

Location

Related Publications (40)

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MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Cognitive Dysfunction; Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zhang-Jin ZHANG, MMed, PhD

  School of Chinese Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 29, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

HK (4); CN (2)