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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-07988 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HUM00274541 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| Hope Foundation | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (LASO-3 sessions) | Experimental | 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. |
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| Arm II (general health education sessions) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment of all participants (Feasibility) | 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). | Up to 2 years |
| Completion of baseline and 12-week patient-reported outcome measures (Feasibility) | 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. | At baseline and 12 weeks |
| Percent of LASO-3 participants who attend at least 5 out of 8 intervention sessions (Feasibility) | 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. | Up to 12 weeks |
| Percent of LASO-3 participants who self-report adherence to dietary goals (Feasibility) | 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. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability and satisfaction with the twelve-week LASO-3 diet intervention | Will determine the LASO-3 diet group participants' perspectives of acceptability and satisfaction with the twelve-week intervention using semi-structured interviews. Semi-structured interviews will be professionally transcribed and analyzed using inductive content analysis. Transcripts will be uploaded to NVivo (QSR International), where Dr. Knoerl and the research team will independently derive codes, collaboratively group them into categories, and identify key themes with representative quotations. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Knoerl | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Recruiting | Ann Arbor | Michigan | 48109 | United States |
we will only share de-identified data with others upon reasonable request
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| Educational Intervention | Other | Attend virtual general health education sessions |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Interview | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| At 12 weeks |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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