Clinical trial · Interventional
Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients (GCC1232)
Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients
NCT01881932CI-TRIAL-00041506terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The PI has moved to another institution, which resulted in significant changes in the study design and study title.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture using Seirin® needles | Device | — | UNRESOLVED |
| Sham Acupuncture using Park Sham placebo acupuncture device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Standard Care
- description
- 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.
- type
- EXPERIMENTAL
- label
- Acupuncture
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.