Acupuncture Chemotherapy-Induced Peripheral Neuropathy (CIPN) IRG

NCT01815346 | Terminated Phase 1 DMC

• 2 other identifiers: 2012-1054NCI-2014-01520
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to compare the level of effectiveness for 2 acupuncture treatment schedules for chronic CIPN in breast cancer survivors. Researchers also want to study how patients may respond to acupuncture treatments, and how the treatments may affect quality of life, hand function, balance, and the use of drugs for neuropathy pain.

Conditions

Breast Cancer

Keywords

Breast Cancer; Breast cancer survivors; Chronic, taxane-based chemotherapy-induced peripheral neuropathy; CIPN; Acupuncture treatments; Quality of life; Hand function; Balance; Questionnaires; Surveys

Outcome Measures

Primary Outcomes (1)

• Score Changes in Neurotoxicity Scale

  Efficacy analysis used employing a paired t-test to estimate the mean changes in the score of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG) Scale separately from baseline to after 12 treatments for each acupuncture schedule. 95% confidence intervals calculated for these estimates. T-test used to compare differences in scores (from baseline to after 12 treatments) between groups.

  4 weeks and 6 weeks

Study Arms (2)

Acupuncture Group - Twice a Week

EXPERIMENTAL

Acupuncture 2 times a week for 6 weeks. Participants receive acupuncture to the arms, legs, and abdomen. The acupuncture needles will be left in place for about 20 minutes.

Procedure: Acupuncture; Behavioral: Questionnaires; Other: Hand Function and Balance Tests

Acupuncture Group - Three Times a Week

EXPERIMENTAL

Acupuncture 3 times a week for 4 weeks. Participants receive acupuncture to the arms, legs, and abdomen. The acupuncture needles will be left in place for about 20 minutes.

Procedure: Acupuncture; Behavioral: Questionnaires; Other: Hand Function and Balance Tests

Interventions

Acupuncture PROCEDURE

One group receives acupuncture 2 times a week for 6 weeks. One group receives acupuncture 3 times a week for 4 weeks. Participants receive acupuncture to the arms, legs, and abdomen. The acupuncture needles will be left in place for about 20 minutes.

Acupuncture Group - Three Times a Week; Acupuncture Group - Twice a Week

Questionnaires BEHAVIORAL

Three questionnaires completed at baseline, midpoint, and four weeks after completion of acupuncture treatment.

Also known as: Surveys

Acupuncture Group - Three Times a Week; Acupuncture Group - Twice a Week

Hand Function and Balance Tests OTHER

Tests completed at baseline, midpoint, and four weeks after completion of acupuncture treatment. These tests should take about 20 minutes to complete.

Acupuncture Group - Three Times a Week; Acupuncture Group - Twice a Week

Eligibility Criteria

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

You may qualify if:

• Patients must have the ability to understand English, sign a written informed consent document, and be willing to follow protocol requirements.
• Age \>/= 18 years.
• History of a diagnosis of breast cancer.
• Patients must have neuropathy greater or equal to 2 according to CTCAE v 4.0 scale, clinically evaluated within 30 days of consent, despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica for at least 30 days. Patients receiving any of these drugs must remain on the same medications throughout the study period; however, adjustments in dosage are allowed. Patients are allowed to stop medications but not replace them with other medications.
• The patient's previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) and considered the primary cause of the neuropathy by the medical team.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
• Ability to complete the 4 or 6 weeks of acupuncture and follow-up assessments.

You may not qualify if:

• Current active treatment with chemotherapy , radiation or surgery in the past 3 months or planned treatment during this study protocol period. Hormonal therapy is allowed.
• Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezumab chemotherapy in the past 6 months.
• Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of infection.)
• Physical deformities that could interfere with accurate acupuncture point location.
• Concurrent use of other alternative medicines such as herbal agents and high dose vitamins.
• Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose. Patients on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will be allowed to participate.
• Platelets \< 50 H K/UL in the past 30 days.
• White blood cells (WBCs) \< 3.0 K/UL or absolute neutrophil count (ANC) \<1,500 K/UL) in the past 30 days.
• Active central nervous system (CNS) disease. (The action for acupuncture may be associated with central nervous system activity, and patients with CNS pathology may respond differently to treatment than the general population.)
• Cardiac pacemaker.
• Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These patients may not be able to cooperate with this slightly invasive procedure or with the data collection process.)
• Currently pregnant. (Certain acupuncture applications have been reported to stimulate uterine contractions.)
• History of diabetic neuropathy or neuropathy related to HIV.
• Previous acupuncture treatment for any indication within 30 days of enrollment.
• Planned or actual changes in type of medications that could affect symptoms related to CIPN. New medications for the treatment of CIPN are not allowed during the study. Note: Subjects need to be on stable doses for 4 weeks.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Bronchiolitis Obliterans Syndrome

Interventions

Acupuncture Therapy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kay Garcia, DRPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 21, 2013
• Study Start: July 6, 2014
• Primary Completion: May 10, 2016
• Study Completion: May 10, 2016
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

US (1)