A Pilot Study of Acupuncture for Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Dana-Farber Cancer Institute
Sponsor:
Collaborator:
The Comprehensive and Integrative Medicine Institute of South Korea
Information provided by (Responsible Party):
Weidong Lu, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT02129686
First received: April 30, 2014
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

This study is being done to evaluate the potential benefits of using acupuncture to reduce symptoms of tingling, burning, numbness and pain in the hands and feet of women with peripheral neuropathy after completion of chemotherapy for breast cancer.


Condition Intervention
Taxane-induced Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Early-Stage Breast Carcinoma
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Procedure: Immediate Acupuncture Group
Procedure: Delayed Acupuncture Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Pilot Study of Acupuncture for Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Response Rate from Baseline in PNQ Score [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    The PNQ includes two questionnaire items: one asking about sensory neurotoxicity and the other asking about motor neurotoxicity. The questionnaire items correspond to the neurotoxicity questions included in the NCI-CTCAE. PNQ grades range from grade A (no neuropathy) to grade E (very severe neuropathy). Answer options will be coded 0=A to 4=E, with a higher score indicating more severe CIPN


Secondary Outcome Measures:
  • Changes in FACT/NTX subscale baseline to 8 weeks [ Time Frame: Baseline, 8 Weeks ] [ Designated as safety issue: No ]
  • Changes in EORTC-QLQ-CIPN20 subscale Baseline, 8 Weeks [ Time Frame: Baseline, 8 Weeks ] [ Designated as safety issue: No ]
    Comprised of three subscales assessing sensory, motor, and autonomic symptoms. Subscale scores will be calculated and linearly transformed to a 0 to 100 scale, with higher scores suggesting more severe symptoms. Changes from baseline (8-week - baseline) between the intervention arms for each subscale will be of interest.


Estimated Enrollment: 40
Study Start Date: June 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate Acupuncture Group

Immediate acupuncture arm will receive acupuncture 3 times per week during week 1 and week 2, then 2 times per week from week 2 to week 8 for a total of 18 sessions. The crossover will take place after 8th week.

The immediate acupuncture arm will enter a follow-up phase without acupuncture for 8 weeks from week 9 to week 16, while the standard usual care will be provided.

Procedure: Immediate Acupuncture Group
Active Comparator: Delayed Acupuncture Group
The patients on the usual care/delayed acupuncture arm will continue their standard usual care with their physicians and care team. The crossover will take place after 8th week. After crossover, the patients initially on the usual care/delayed acupuncture arm will receive the identical acupuncture protocol but a less frequent schedule from week 9 to week 16: 2 times per week at week 9, then 1 time per week from week 10 to week 16 for a total of 9 sessions
Procedure: Delayed Acupuncture Group

Detailed Description:

Chemotherapy drugs used to treat cancer can cause temporary or permanent damage to the nerves in the hands and feet, a condition called "chemotherapy-induced peripheral neuropathy". The most common symptoms of chemotherapy-induced peripheral neuropathy are pain, tingling, burning or numbness sensation, which can lead to balance problems or trouble using fingers or pick up/holding things. These symptoms often last months to years after the completion of chemotherapy. Medications and nutritional supplements can ease the symptoms of chemotherapy-induced peripheral neuropathy, but many patients continue to experience symptoms despite these treatments.

Acupuncture is an intervention in which hair-thin, stainless steel needles are shallowly inserted into specific points on the skin, with the goal of influencing the body's natural healing system. Acupuncture has been studied in clinical trials in cancer patients and has been shown to be effective for various conditions including chemotherapy-induced nausea and vomiting. A few preliminary studies have suggested that acupuncture may help to reduce symptoms of peripheral neuropathy, but more information is needed about the benefits of acupuncture in breast cancer patients This study is being done to evaluate the potential benefits of using acupuncture to reduce symptoms of tingling, burning, numbness and pain in the hands and feet of women with peripheral neuropathy after completion of chemotherapy for breast cancer.

This research study will help to determine the benefits of acupuncture for the treatment of chemotherapy-induced peripheral neuropathy. The study will also look at two different acupuncture schedules to determine whether patients derive benefits from lower and higher dose acupuncture treatments.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of histologically or cytologically proven breast cancer at stage I, II and III, without evidence of distant metastasis;
  • Completed adjuvant taxane-based chemotherapy as single agents or in combination with platins or HER-2 directed therapy
  • Reporting grade 1 or greater of the following symptoms persistently for more than 2 weeks: neuropathic pain, allodynia, areflexia, dysesthesia, paresthesia, hyperesthesia, hypoesthesia or glove and stocking syndrome as defined by Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) (Table 1 and the screening checklist);
  • Patients who are currently on stable prescription medications or dietary supplements for CIPN and still symptomatic as defined above will be allowed to participate in the study. Related medications are: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; NSAIDs; glutamine, glutathione, vitamin E and vitamin B12;
  • Age ≥ 18 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Adequate hematological function: neutrophil count >1.0 x109/L, platelet count >50x109/L;
  • Signed informed consent.

Exclusion Criteria:

  • Patients with any of the following criteria will not be eligible for the study:
  • Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
  • Wearing a pacemaker or implantable cardioverter-defibrillator; uncontrolled seizure disorder;
  • History of pre-existing peripheral neuropathy prior to chemotherapy, including alcoholism, vitamin B deficiency, diabetes, HIV, congenital neuropathy, toxic neuropathy;
  • Peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or surgical trauma;
  • Pregnancy or potential pregnancy and nursing;
  • Active clinically significant uncontrolled infection;
  • Prior use of acupuncture for CIPN within 6 months prior to study entry;
  • Patients with uncontrolled major psychiatric disorders, such as major depression or psychosis, will not be eligible for this trial. Patients with a history of depression or anxiety who are stable on or off psychiatric medications will be eligible.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02129686

Contacts
Contact: Weidong Lu, MB, MPH, Ph.D (617) 632-3322 Weidong_lu@dfci.harvard.edu

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Weidong Lu, M.B.,MPH, PhD    (617) 632-3322    Weidong_lu@dfci.harvard.edu   
Principal Investigator: Weidong Lu, M.B., MPH, PhD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
The Comprehensive and Integrative Medicine Institute of South Korea
Investigators
Principal Investigator: Weidong Lu, M.B., MPH, Ph.D Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Weidong Lu, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02129686     History of Changes
Other Study ID Numbers: 14-067
Study First Received: April 30, 2014
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Chemotherapy-induced peripheral neuropathy (CIPN)
Acupuncture
Early-Stage Breast Carcinoma
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Peripheral Nervous System Diseases
Breast Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Nervous System Diseases
Neuromuscular Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 29, 2014