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

November 5, 2019 updated by: University of Maryland, Baltimore

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Marlene & Stewart Greenebaum Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (ESTIMATE)

June 20, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00053394
  • GCC1232 (OTHER: University of Maryland Greenebaum Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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