Chemotherapy-Induced Peripheral NeuropathyNCT07365007
A Virtually Delivered Diet Intervention (LASO-3) for the Improvement of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors Post-treatment
A study testing Biospecimen Collection, Educational Intervention and Electronic Health Record Review in people with Chemotherapy-Induced Peripheral Neuropathy and Hematopoietic and Lymphatic System Neoplasm, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Biospecimen Collection, Educational Intervention and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Robert Knoerl, 734-764-8617, rjknoerl@med.umich.edu
Robert Knoerl
About this study
Official title: Feasibility of a Virtually Delivered LASO-3 Diet Intervention for Chemotherapy-Induced Peripheral Neuropathy in Post-Treatment Cancer Survivors
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.
Read the detailed description
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).
- Conditions
- Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- Being tested
- Biospecimen Collection, Educational Intervention, Electronic Health Record Review, Interview, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Attend virtual general health education sessions
Electronic Health Record ReviewOther
Ancillary studies
InterviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Interview; Other: Survey Administration |
| 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. Receives: Procedure: Biospecimen Collection; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 weeks
Secondary outcomes (1)
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.
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start23 Feb 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hope Foundation
- Responsible party
- Sponsor
- Investigators
- Robert Knoerl, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365007
- Sponsor's protocol ID
- UMCC 2025.077
- Other IDs
- NCI-2025-07988, HUM00274541
- Status last verified
- Jun 2026
- First submitted
- 15 Jan 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we will only share de-identified data with others upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Virtually Delivered LASO-3 Diet Intervention for Chemotherapy-Induced Peripheral Neuropathy in Post-Treatment Cancer Survivors
- ClinicalTrials.gov ID
- NCT07365007
- Acronym / sponsor ID
- UMCC 2025.077
- Conditions
- Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Hope Foundation
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (LASO-3 sessions) | Experimental | Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Interview, Other: Survey AdministrationPatients 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. |
| Arm II (general health education sessions) | Active comparator | Procedure: Biospecimen Collection, Other: Educational Intervention, Other: Electronic Health Record Review, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm I (LASO-3 sessions), Arm II (general health education sessions) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalAttend virtual general health education sessions | Other | Arm II (general health education sessions) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I (LASO-3 sessions), Arm II (general health education sessions) |
| InterviewAncillary studies | Other | Arm I (LASO-3 sessions) |
| Survey AdministrationAncillary studies | Other | Arm I (LASO-3 sessions), Arm II (general health education sessions) |
Primary outcome
Recruitment of all participants (Feasibility)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Acceptability and satisfaction with the twelve-week LASO-3 diet intervention
Time frame: At 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No. we will only share de-identified data with others upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Michigan Rogel Cancer Center
Ann Arbor, United States
Robert Knoerl principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Educational Intervention and Electronic Health Record Review in people with Chemotherapy-Induced Peripheral Neuropathy and Hematopoietic and Lymphatic System Neoplasm, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment of all participants (Feasibility) (time frame: Up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.