Feasibility of a Virtually Delivered LASO-3 Diet Intervention for Chemotherapy-Induced Peripheral Neuropathy in Post-Treatment Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recruitment of all participants (Feasibility)
研究概览
简要总结
This clinical trial studies whether a virtually delivered diet intervention focused on lower added sugar, higher fiber, and higher omega 3 fatty acid (LASO-3) can be used to improve chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors after treatment. Cancer survivors often experience CIPN during and after cancer treatment with neurotoxic chemotherapy. CIPN is characterized by nerve damage from chemotherapy that leads to numbness, tingling, or pain in the hands or feet. However, there are few treatments to manage CIPN. Inflammation contributes to the development of CIPN and dietary patterns that have been demonstrated to improve diet quality and reduce inflammation in cancer survivors may be promising for use as a CIPN management strategy. The LASO-3 diet intervention consists of virtually delivered nutrition education sessions provided by a Registered Dietitian. The sessions focus on three dietary goals, informed by the United States Dietary Guidelines for Americans: 1) lowering added sugar intake to < 10% of daily calories, 2) increasing daily fiber intake to ≥ 20 grams, and 3) increasing intake of moderate-high omega-3 seafood to three or more servings weekly or 3300-3400 mg/day of alpha-linolenic acid (e.g., plant-based sources include canola or flaxseed oil, walnuts, or flaxseed or chia seeds). The Registered Dietitian tailors the sessions to the patient based on information and feedback obtained throughout the sessions. The LASO-3 diet intervention may be an effective way to improve CIPN in cancer survivors after treatment.
详细描述
02MAY2026- Amendment was approved to update inflammatory disease exclusion criteria.
28MAY2026- Amendment was approved to clarifying the eligibility to exclude individuals who have preexisting peripheral neuropathy (instead of neuropathy overall as this is not specific and could include centralized pain).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •At least three months since last receiving neurotoxic chemotherapy
- •Self-report moderate (≥ 2/4) numbness and tingling on the Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE™) Numbness and Tingling Severity Item in the last week
- •Speak/read English
- •Have access to the internet
排除标准
- •Pre-existing peripheral neuropathy from any cause
- •Plan to begin a new prescription of duloxetine (i.e., first-line treatment for CIPN pain) during the study period
- •Are enrolled in symptom management trials that may alter CIPN severity
- •High grade inflammatory disease such as lupus, Crohn's disease, or rheumatoid arthritis
- •Routine nonsteroidal anti-inflammatory drug (NSAID) or steroid supplementation
- •Consuming an average three or more servings of fish per week and/or consuming fish oil capsules containing eicosapentaenoic acid (EPA)+ docosahexaenoic acid (DHA) daily or consuming flax oil capsules daily
- •Consuming an average of less than 5 servings of sweets, candy bars, chocolate, doughnuts, cookies, cakes, pie, brownies, ice cream, pastries, or sugar sweetened beverages (e.g., soda or coffee/tea) per week
研究组 & 干预措施
Arm I (LASO-3 sessions)
Patients attend virtual LASO-3 nutrition counseling sessions over 30 minutes QW for 4 weeks followed by LASO-3 nutrition counseling sessions over 15 minutes Q2W for 8 weeks. Patients also undergo blood sample collection throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Arm I (LASO-3 sessions)
Patients attend virtual LASO-3 nutrition counseling sessions over 30 minutes QW for 4 weeks followed by LASO-3 nutrition counseling sessions over 15 minutes Q2W for 8 weeks. Patients also undergo blood sample collection throughout the trial.
干预措施: Interview (Other)
Arm I (LASO-3 sessions)
Patients attend virtual LASO-3 nutrition counseling sessions over 30 minutes QW for 4 weeks followed by LASO-3 nutrition counseling sessions over 15 minutes Q2W for 8 weeks. Patients also undergo blood sample collection throughout the trial.
干预措施: Electronic Health Record Review (Other)
Arm I (LASO-3 sessions)
Patients attend virtual LASO-3 nutrition counseling sessions over 30 minutes QW for 4 weeks followed by LASO-3 nutrition counseling sessions over 15 minutes Q2W for 8 weeks. Patients also undergo blood sample collection throughout the trial.
干预措施: Survey Administration (Other)
Arm II (general health education sessions)
Patients attend eight virtual general health education sessions over 15-30 minutes each over 12 weeks. Patients also undergo blood sample collection throughout the trial. Patients may also receive the intervention materials and up to 4 dietary counseling sessions post-study.
干预措施: Biospecimen Collection (Procedure)
Arm II (general health education sessions)
Patients attend eight virtual general health education sessions over 15-30 minutes each over 12 weeks. Patients also undergo blood sample collection throughout the trial. Patients may also receive the intervention materials and up to 4 dietary counseling sessions post-study.
干预措施: Educational Intervention (Other)
Arm II (general health education sessions)
Patients attend eight virtual general health education sessions over 15-30 minutes each over 12 weeks. Patients also undergo blood sample collection throughout the trial. Patients may also receive the intervention materials and up to 4 dietary counseling sessions post-study.
干预措施: Electronic Health Record Review (Other)
Arm II (general health education sessions)
Patients attend eight virtual general health education sessions over 15-30 minutes each over 12 weeks. Patients also undergo blood sample collection throughout the trial. Patients may also receive the intervention materials and up to 4 dietary counseling sessions post-study.
干预措施: Survey Administration (Other)
结局指标
主要结局
Recruitment of all participants (Feasibility)
时间窗: Up to 2 years
Feasibility will be established if the following benchmark is met, recruitment of all participants within a two-year period (Demand). The observed recruitment rate will be estimated along with exact 80% confidence intervals (CIs).
Completion of baseline and 12-week patient-reported outcome measures (Feasibility)
时间窗: At baseline and 12 weeks
Feasibility will be established if the following benchmark is met, ≥ 60% completion of baseline and 12-week patient-reported outcome measures. The observed retention rate will be estimated along with exact 80% CIs.
Percent of LASO-3 participants who attend at least 5 out of 8 intervention sessions (Feasibility)
时间窗: Up to 12 weeks
Feasibility will be established if the following benchmark is met, ≥ 60% of LASO-3 participants attend at least 5 out of 8 intervention sessions (Implementation). The observed retention rate will be estimated along with exact 80% CIs.
Percent of LASO-3 participants who self-report adherence to dietary goals (Feasibility)
时间窗: Up to 24 weeks
Feasibility will be established if the following benchmark is met, ≥ 60% of LASO-3 participants self-report adherence to dietary goals via VioScreen food frequency questionnaire and/or monthly adherence checklists (Practicality). The observed adherence rate will be estimated along with exact 80% CIs.
次要结局
- Acceptability and satisfaction with the twelve-week LASO-3 diet intervention(At 12 weeks)