Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients (GCC1232)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
Ting Bao, University of Maryland
ClinicalTrials.gov Identifier:
NCT01881932
First received: March 13, 2013
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

In this study the investigators will assess how useful and safe acupuncture is in easing the pain, tingling and numbness that is caused by chemotherapy. The researchers hope this will prevent the need to reduce the amount of chemotherapy a patient receives.


Condition Intervention
Breast Cancer
Colorectal Cancer
Device: Acupuncture using Seirin® needles
Device: Sham Acupuncture using Park Sham placebo acupuncture device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Proportion of colorectal and breast cancer patients in each arm who require dose reduction or discontinuation due to chemotherapy-induced peripheral neuropathy. [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    The main objective is to assess efficacy and safety of acupuncture using Seirin acupuncture needles in colorectal and breast cancer patients who developed chemotherapy-induced peripheral neuropathy while receiving adjuvant/neoadjuvant chemotherapy. Safety will be assessed by recording side effects from acupuncture treatment. Efficacy will be assessed by measuring the proportion of patients in each arm who are required to undergo dose reduction or discontinuation due to chemotherapy-induced peripheral neuropathy.


Secondary Outcome Measures:
  • Chemotherapy cumulative relative dose intensity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The investigators will measure cumulative relative dose intensity of chemotherapy. The acupuncture and sham acupuncture arms will be compared with the expectation that the acupuncture arm will have a higher cumulative relative dose intensity.

  • Level of neurotoxicity as assessed by the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The investigators will compare effects of chemotherapy by comparing the interim and final levels of neurotoxicity between acupuncture and sham acupuncture arms.

  • Neuropathic pain as assessed by Neuropathy Pain Scale (NPS) questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The investigators will measure the levels of neuropathic pain using the NPS. They will compare the acupuncture and sham acupuncture arms with regard to pain with the expectation that patients in the acupuncture arm will experience less pain than those in the sham acupuncture arm.

  • Level of nerve conduction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    In order to explore possible mechanism of acupuncture, the investigators will explore whether patients in the acupuncture arm have better nerve conduction than those in the acupuncture arm, and whether changes in function and pain correlate with changes in nerve conduction function.

  • Serum concentrations of nerve growth factor and other neurotrophic factors [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    In order to explore possible mechanism of acupuncture, the investigators will explore whether serum concentrations of nerve growth factors and other neurotrophic biomarkers differ between the treatment arms, and whether changes in function and pain correlate with changes in serum nerve growth factors and other neurotrophic factors.


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Care
Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
Experimental: Acupuncture
Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). The patients will be randomly assigned to receive acupuncture until the end of their chemotherapy. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not receive additional therapy for CIPN.
Device: Acupuncture using Seirin® needles

Participants will receive acupuncture weekly until the end of chemotherapy.

Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points , and immediately affix a pair of needles to the surface of the same points with adhesive tape, without needle insertion.

Active Comparator: Sham Acupuncture
Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). The patients will be randomly assigned to receive sham acupuncture until the end of their chemotherapy while following the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels.
Device: Sham Acupuncture using Park Sham placebo acupuncture device

Participants will receive sham acupuncture until the end of chemotherapy.

Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape next to the needles. In addition, she will tap a mock plastic needle guiding tube on the surface of each of the 8 true points in the arm and leg to produce some discernible sensation and then immediately apply a needle with a piece of adhesive tape to the dermal surface, without needle insertion.


Detailed Description:

This is a single-center, pilot (phase IIb), randomized, standard care- and placebo (sham acupuncture)-controlled clinical trial (N=60) assessing the effects of acupuncture to prevent chemotherapy dose reduction due to chemotherapy-induced peripheral neuropathy (CIPN) and to elucidate the mechanism of action. Breast or colorectal cancer patients receiving neoadjuvant or adjuvant chemotherapy containing neurotoxic agents (taxanes or oxaliplatin) at the University of Maryland Marlene & Stewart Greenebaum Cancer Center (UMGCC) will be screened for CIPN. Once these patients develop greater than or equal to National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 CIPN, they will be recruited for this study. Severity of CIPN as defined by NCI-CTC is listed in Appendix A. Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). The patients will then be randomly assigned to one of three arms: (A) real acupuncture, (B) sham acupuncture or (C) standard care. All patients will follow the same chemotherapy dose reduction algorithm (Appendix B). No concomitant anti-neuropathy medication is allowed. Patients in the intervention arms will be randomly assigned to undergo weekly real or sham acupuncture until the end of their chemotherapy. In these two arms, the patient, the patient's medical oncologist, pharmacist, research nurse, and study coordinator will be blinded to the treatment assignment. In standard care arm, patients will not receive additional therapy for CIPN. Their CIPN will be managed according to the standard chemotherapy dose reduction algorithm. In all arms, chemotherapy dose will be documented during the patient's scheduled chemotherapy sessions. The chemotherapy relative dose intensity (RDI) will be calculated at the end of their chemotherapy. Validated patient-reported outcome questionnaires: Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire and Neuropathy Pain Scale (NPS), described later, will be used to assess CIPN severity weekly in all patients until the end of their chemotherapy and at the 4 week follow up. Nerve conduction study will be performed by a neurologist at baseline and after chemotherapy is finished. Side effects from real or sham acupuncture will be recorded weekly. Approximately 4 ml of blood will be drawn from patients before each real or sham acupuncture treatment, or with routine weekly blood work check (in the standard care arm), at the end of chemotherapy, and at the 4 week follow up to measure changes in nerve growth factor and other neurotrophic factors such as brain-derived neurotrophic factor, neurotrophin-3, the insulin-like growth factors, and vascular endothelial growth factor. They will be analyzed in the cytokine lab at the University of Maryland School of Medicine (UMSOM).

  Eligibility

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

Inclusion Criteria:

  • Histologically proven stage I-III carcinoma of the breast OR histologically proven stage I-III colorectal carcinoma.
  • Receiving adjuvant or neoadjuvant chemotherapy that includes a taxane or oxaliplatin.
  • While on chemotherapy, develop greater than or equal to NCI-CTC grade 2 CIPN.
  • Eastern Cooperative Oncology Group performance status 0-2.
  • The patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.

Exclusion Criteria:

  • Prior acupuncture within one year of enrollment.
  • Known metastatic (stage IV) breast or colorectal cancer involvement.
  • Pre-existing peripheral neuropathy before chemotherapy is initiated
  • Currently taking anti-neuropathy medication such as gabapentin, or pregabalin.
  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: NCT01881932

Contacts
Contact: James Primrose, RN 410-328-4827 jprimrose@umm.edu
Contact: Michelle Medeiros 410-328-1160 mmedieros@umm.edu

Locations
United States, Maryland
University of Maryland Marlene & Stewart Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Ting Bao, MD, DABMA         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Ting Bao, MD, DABMA University of Maryland Marlene & Stewart Greenebaum Cancer Center
  More Information

No publications provided

Responsible Party: Ting Bao, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01881932     History of Changes
Other Study ID Numbers: HP-00053394, GCC1232
Study First Received: March 13, 2013
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
acupuncture therapy
sham acupuncture therapy
chemotherapy-induced peripheral neuropathy (CIPN)

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 01, 2014