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

NCT01881932 | Terminated Results DMC

• 2 other identifiers: HP-00053394GCC1232
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Colorectal Cancer

Keywords

acupuncture therapy; sham acupuncture therapy; chemotherapy-induced peripheral neuropathy (CIPN)

Outcome Measures

Primary Outcomes (1)

• Proportion of Colorectal and Breast Cancer Patients in Each Arm Who Require Dose Reduction or Discontinuation Due to Chemotherapy-induced Peripheral Neuropathy.

  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

Study Arms (3)

Standard Care

NO INTERVENTION

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.

Acupuncture

EXPERIMENTAL

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

Sham Acupuncture

ACTIVE COMPARATOR

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

Interventions

Acupuncture using Seirin® needles DEVICE

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.

Acupuncture

Sham Acupuncture using Park Sham placebo acupuncture device 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.

Sham Acupuncture

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Marlene & Stewart Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

The PI left the institution before the end of the study; therefore the study was withdrawn in clinicaltrials.gov and IRB closed.

Results Point of Contact

• Title: Michelle Medeiros
• Organization: University of Maryland Baltimore Greenebaum Cancer Center

mmedeiros@umm.edu

410-328-1160

Study Officials

• Ting Bao, MD, DABMA

  University of Maryland Marlene & Stewart Greenebaum Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: June 20, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: April 1, 2015
• Last Updated: November 7, 2019
• Results First Posted: October 7, 2015

Record last verified: 2019-11

Locations

US (1)