Phase 2, Single Center, Single Arm Study to Evaluate the Decrease in CIPN With the Addition of Hydroxychloroquine to Chemotherapy in Patients With Early Stage (1-3) Breast Cancer and Gynecological Cancers Treated With Curative Intent
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Symptomatic CIPN
研究概览
简要总结
The study is being done to research if hydroxychloroquine can prevent chemotherapy induced peripheral neuropathy. Certain chemotherapy drugs, like paclitaxel, are known to cause neuropathy which can impact quality of life. Currently, there are no options for preventing peripheral neuropathy. In addition, there are no useful methods to assess peripheral nerve damage. This study will also explore using a study MRI of patients' feet prior to starting chemotherapy and after they have completed chemotherapy to see if there is any difference in their nerve structure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with stage 1-3 breast cancer or gynecological cancer treated with curative intent
- •Age ≥ 21 years old
- •No prior neurotoxic chemotherapies
- •No other neurotoxic chemotherapies planned during paclitaxel treatment (i.e, platinum)
- •Need to be treated with paclitaxel weekly x 12 doses as determined by their treating physician
- •Be able to undergo MR Imaging
- •Be willing to comply with scheduled visits, treatment plan, and MR imaging
- •Adequate organ function as defined as:
- •Hematologic:
- •Absolute neutrophil count (ANC) ≥ 1500/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 9 g/dL
- •Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
- •Estimated creatinine clearance (CrCl)≥ 50 mL/min by Cockcroft-Gault formula
排除标准
- •Stage IV cancer
- •CTCAE neurological function > grade 1 at baseline
- •Mental limitation that precludes understanding of or completion of questionnaires
- •History of diabetes or other neurological disorders
- •Preexisting peripheral neuropathy
- •Prior exposure to neurotoxic chemotherapy
- •Currently taking medication to treat or prevent neuropathy
- •Have non-MRI compatible metallic objects on/in body
- •Have metallic hardware in the lower extremity which is MR compatible however would create too much artifact for MR examination
- •Pregnant or lactating patients. Women of childbearing potential and sexually active men must use an effective contraception method during rreatment and for three months after completing treatment. Patients of childbearing potential must have a negative serum or urine B-hCG pregnancy test at screening.
- •History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity) or macular degeneration.
- •QTc prolongation defined as a QTcF > 500 ms
- •Known glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
研究组 & 干预措施
Addition of Hydroxychloroquine to paclitaxel
Hydroxychloroquine will be added to chemotherapy in patients with early stage (1-3) breast cancer and gynecological cancers.
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Symptomatic CIPN
时间窗: Throughout study completion, an average of 6 months
The primary endpoint is symptomatic CIPN defined as increase in in FACT-GOG/Ntx-12 questionnaire score of greater than or equal to 3 points post-chemotherapy with hydroxychloroquine in combination with paclitaxel chemotherapy in patients with early-stage breast cancer or gynecologic malignancies.
次要结局
- Predicting Symptomatic CIPN: FA and ADC values derived from DTI(Baseline)
- Predicting Symptomatic CIPN: change in FA and ADC(Baseline and 12 weeks)
- Predicting Symptomatic CIPN: baseline NF-L levels(Baseline)
- Predicting Symptomatic CIPN: Changes in NF-L levels(Baseline and 12 weeks)