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

NCT ID: NCT01881932

Last Updated: 2019-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-04-30

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.

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).

Conditions

Breast Cancer; Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Acupuncture using Seirin® needles

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Sham Acupuncture using Park Sham placebo acupuncture device

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ting Bao, MD, DABMA

Role: PRINCIPAL_INVESTIGATOR

University of Maryland Marlene & Stewart Greenebaum Cancer Center

Locations

University of Maryland Marlene & Stewart Greenebaum Cancer Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

GCC1232

Identifier Type: OTHER

Identifier Source: secondary_id

HP-00053394

Identifier Type: -

Identifier Source: org_study_id