Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients (GCC1232)
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Colorectal Cancer, Cancer, Cancer, Neurology |
| Therapuetic Areas: | Neurology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2013 |
| End Date: | April 2015 |
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.
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.
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).
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).
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.
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