Non Small Cell Lung CancerPhase 2NCT03628144
Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer
A Phase 2 study testing Impact® Advanced Recovery, Boost® High Protein and Radiation Therapy in people with Non Small Cell Lung Cancer and NSCLC, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to assess whether either or both nutrition supplements (Impact® Advanced Recovery or Boost® High Protein) ingested prior to and during concurrent chemoradiotherapy decreases toxic side effects of treatment in Stage IIIA-B non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, NSCLC, Non-small Cell Lung Cancer
- What is being tested?
- Impact® Advanced Recovery, Boost® High Protein and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2020to Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patients will be recruited from the Moffitt Cancer Center Thoracic Oncology Outpatient Clinic when identified by a thoracic oncologist that the patient will undergo all of their chemoradiotherapy at Moffitt.
- Men and women ≥18 years of age.
- Diagnosed with unresectable stage IIIA or IIIB non-small cell lung cancer.
- Patients plan to undergo all cancer treatment at Moffitt Cancer Center with definitive concurrent chemotherapy and radiotherapy.
- No prior treatment of NSCLC.
- Able to provide informed consent.
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- Performance status 0, 1 or 2.
- Life expectancy >3 months.
- No esophagitis within 90 days.
Who cannot join
- Mental incompetence or chronic psychiatric disease.
- Incarcerated individuals.
- Use of antibiotics or probiotic supplements within one month of chemoradiotherapy.
- Allergy to any of the components of Impact® Advanced Recovery or Boost® High Protein.
- Pregnant female or breast-feeding. Any female patient <45 years old not using appropriate contraceptive measures during the treatment.
- Sepsis or active infection.
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- Chronic renal failure stage IV (requiring protein restriction) or stage V requiring dialysis.
- Malnutrition defined as BMI <16.
- Inflammatory bowel disease (ulcerative colitis or Crohn's disease).
- Severe hepatic dysfunction (baseline prothrombin time off any anticoagulation of international normalized ratio (INR) >1.8).
- Significant digestive disease with nausea, vomiting or diarrhea, NCI Grade >1.
- Use of IL-6 inhibitors (tocilizumab or siltuximab) within last 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: The Use of Immunonutrition to Reduce Toxicities From Concurrent Chemotherapy and Radiotherapy for Treatment of Unresectable Stage IIIA-B Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to assess whether either or both nutrition supplements (Impact® Advanced Recovery or Boost® High Protein) ingested prior to and during concurrent chemoradiotherapy decreases toxic side effects of treatment in Stage IIIA-B non-small cell lung cancer.
- Conditions
- Non Small Cell Lung Cancer, NSCLC, Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage ⅢA, NSCLC Stage IIIB
- Being tested
- Impact® Advanced Recovery, Boost® High Protein, Radiation Therapy, Chemotherapy, Quality of life (EORTC-QLQ-30)
- Keywords
- Immunonutrition, Radiotherapy, Unresectable, Stage IIIA-B, Lung cancer, Radiation oncology, Thoracic oncology, Epidemiology, Nutrition
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact® Advanced RecoveryDietary supplement
Also called Nutritional supplement
The intervention drink Impact® will be ingested every two weeks since usually chemotherapy is delivered concurrently with radiation therapy in 2 week cycles. For patients who are placed on weekly or every 4 weeks chemotherapy dosing schedules, the treatment and control supplements will still be given every two weeks.
Boost® High ProteinDietary supplement
Also called Nutritional supplement
The control supplement drink Boost® will be ingested every two weeks since usually chemotherapy is delivered concurrently with radiation therapy in 2 week cycles. For patients who are placed on weekly or every 4 weeks chemotherapy dosing schedules, the treatment and control supplements will still be given every two weeks.
Radiation TherapyRadiation
Also called Radiotherapy
Standard of Care: Weekly radiation therapy as already planned for each participant, at Moffitt clinic visits.
ChemotherapyDrug
Also called Standard of Care
Standard of Care: Chemotherapy as already planned for each participant.
Quality of life (EORTC-QLQ-30)Other
Also called Questionnaire
Participants will undergo pre- and post-treatment assessments.
Evaluation of Cognitive Function (FACT-Cog, v. 3.0)Other
Also called Questionnaire
Participants will undergo pre- and post-treatment assessments.
Mindfulness Questionnaire (FFMQ)Other
Also called Questionnaire
Participants will undergo pre- and post-treatment assessments.
| Study group | Role | What they receive |
|---|---|---|
| A: Intervention Group - Impact® | Experimental | A: Intervention Group - Standard of Care Concurrent Chemoradiotherapy (Chemotherapy + Radiation) with nutritional supplement. Impact® Advanced Recovery: Three times daily for the 5 days just prior to the start of each cycle of chemotherapy. Participants will undergo pre- and post-treatment assessments. Receives: Dietary Supplement: Impact® Advanced Recovery; Radiation: Radiation Therapy; Drug: Chemotherapy; Other: Quality of life (EORTC-QLQ-30); Other: Evaluation of Cognitive Function (FACT-Cog, v. 3.0); Other: Mindfulness Questionnaire (FFMQ) |
| B: Control Group - Boost® | Active comparator | B: Control Group - Standard of Care Concurrent Chemoradiotherapy (Chemotherapy + Radiation) with nutritional supplement. Boost® High Protein: Identical schedule of a supplement with similar calorie and protein content, Boost® High Protein. Participants will undergo pre- and post-treatment assessments. Receives: Dietary Supplement: Boost® High Protein; Radiation: Radiation Therapy; Drug: Chemotherapy; Other: Quality of life (EORTC-QLQ-30); Other: Evaluation of Cognitive Function (FACT-Cog, v. 3.0); Other: Mindfulness Questionnaire (FFMQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Related Adverse Events Per Study Arm
Overall toxicity from therapy as assessed by NCI Common Toxicity Criteria for Adverse Events (CTCAE) v. 5.0 that directly correlates with toxicity from concurrent chemoradiotherapy. Based on another randomized trial using pretreatment immunonutrition, investigators want to see if this nutritional intervention will likely decrease overall chemoradiotherapy related toxicity. All toxicity and adverse events (CTCAE v.5.0) will be assessed weekly and attributed by the treating radiation oncologist and entered into the clinical trials management database OnCore for later statistical analysis. Differences in toxicity events at the end of the study in participants receiving Impact® and those receiving Boost® will be compared using two-sample t-test.
Measured: Up to 48 months
Change in Plasma Levels of IL-6 Per Study Arm
Measurement of the marked change of IL-6 that directly correlates with toxicity from concurrent chemoradiotherapy. Multiplex immunoassay will be used to determine the plasma levels of IL-6 in pg/ml as a continuous variable. Two-sample t-test for change in IL-6 at the last visit from the baseline will be compared between the two arms. Kolmogorove-Smirnov and Jarque-Bera tests will be performed to test for normality assumption on the primary endpoints prior to t-test analysis. If either test indicates a violation of the normality assumption, investigators will use an appropriate rank-based Wilcoxon rank-sum test instead of t-test.
Measured: Up to 48 months
Secondary outcomes (4)
Overall Survival (OS) 9OS)
Overall survival (OS) defined as the length of time interval between the date of cancer treatment completion and the date of death due to any cause. Kaplan-Meier curves will be estimated for each arm. Log-rank test will be performed to examine the effect of Impact® vs. Boost® on measures of OS.
Measured: Up to 2 years
Progression-free Survival (PFS)
Progression-free survival (PFS) will be assessed using the length of time interval from the cancer treatment completion to the earlier of the first documentation of disease progression or death from any cause. Kaplan-Meier curves will be estimated for each arm. Log-rank test will be performed to examine the effect of Impact® vs. Boost® on measures of PFS.
Measured: Up to 2 years
Rate of Treatment Changes or Interruptions Per Study Arm
Treatment interruptions, chemotherapy dose reduction or hospitalizations secondary to toxicity.
Measured: Up to 2 years
Rate of Participant Regimen Compliance Per Study Arm
Rate of participant compliance, with immunonutrition regimen, according to participant diaries. Each participant will complete a compliance diary noting when each carton/bottle of the study agent is drunk and the card will be collected by the Study Coordinator at on treatment clinic visits (OTV) prior to receiving the new batch of study or control supplements.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study startJul 2020 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nestle Health Science
- Responsible party
- Sponsor
- Investigators
- Lary A. Robinson, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628144
- Sponsor's protocol ID
- MCC-19505
- Status last verified
- Sep 2020
- First submitted
- 9 Aug 2018
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Immunonutrition to Reduce Toxicities From Concurrent Chemotherapy and Radiotherapy for Treatment of Unresectable Stage IIIA-B Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT03628144
- Acronym / sponsor ID
- MCC-19505
- Conditions
- Non Small Cell Lung Cancer, NSCLC, Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage ⅢA, NSCLC Stage IIIB
- Keywords
- Immunonutrition, Radiotherapy, Unresectable, Stage IIIA-B, Lung cancer, Radiation oncology, Thoracic oncology, Epidemiology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Nestle Health Science
- Study start
- Jul 2020 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 14 Aug 2018 (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.
The purpose of this study is to assess whether either or both nutrition supplements (Impact® Advanced Recovery or Boost® High Protein) ingested prior to and during concurrent chemoradiotherapy decreases toxic side effects of treatment in Stage IIIA-B non-small cell lung cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Intervention Group - Impact® | Experimental | Dietary Supplement: Impact® Advanced Recovery, Radiation: Radiation Therapy, Drug: Chemotherapy, Other: Quality of life (EORTC-QLQ-30), Other: Evaluation of Cognitive Function (FACT-Cog, v. 3.0), Other: Mindfulness Questionnaire (FFMQ)A: Intervention Group - Standard of Care Concurrent Chemoradiotherapy (Chemotherapy + Radiation) with nutritional supplement. Impact® Advanced Recovery: Three times daily for the 5 days just prior to the start of each cycle of chemotherapy. Participants will undergo pre- and post-treatment assessments. |
| B: Control Group - Boost® | Active comparator | Dietary Supplement: Boost® High Protein, Radiation: Radiation Therapy, Drug: Chemotherapy, Other: Quality of life (EORTC-QLQ-30), Other: Evaluation of Cognitive Function (FACT-Cog, v. 3.0), Other: Mindfulness Questionnaire (FFMQ)B: Control Group - Standard of Care Concurrent Chemoradiotherapy (Chemotherapy + Radiation) with nutritional supplement. Boost® High Protein: Identical schedule of a supplement with similar calorie and protein content, Boost® High Protein. Participants will undergo pre- and post-treatment assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients will be recruited from the Moffitt Cancer Center Thoracic Oncology Outpatient Clinic when identified by a thoracic oncologist that the patient will undergo all of their chemoradiotherapy at Moffitt.
Key exclusion criteria (12 listed)
- Mental incompetence or chronic psychiatric disease.
- Incarcerated individuals.
- Use of antibiotics or probiotic supplements within one month of chemoradiotherapy.
- Allergy to any of the components of Impact® Advanced Recovery or Boost® High Protein.
- Pregnant female or breast-feeding. Any female patient <45 years old not using appropriate contraceptive measures during the treatment.
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 |
|---|---|---|
| Impact® Advanced RecoveryAlso: Nutritional supplementThe intervention drink Impact® will be ingested every two weeks since usually chemotherapy is delivered concurrently with radiation therapy in 2 week cycles. For patients who are placed on weekly or every 4 weeks chemotherapy dosing schedules, the treatment and control supplements will still be given every two weeks. | Dietary supplement | A: Intervention Group - Impact® |
| Boost® High ProteinAlso: Nutritional supplementThe control supplement drink Boost® will be ingested every two weeks since usually chemotherapy is delivered concurrently with radiation therapy in 2 week cycles. For patients who are placed on weekly or every 4 weeks chemotherapy dosing schedules, the treatment and control supplements will still be given every two weeks. | Dietary supplement | B: Control Group - Boost® |
| Radiation TherapyAlso: RadiotherapyStandard of Care: Weekly radiation therapy as already planned for each participant, at Moffitt clinic visits. | Radiation | A: Intervention Group - Impact®, B: Control Group - Boost® |
| ChemotherapyAlso: Standard of CareStandard of Care: Chemotherapy as already planned for each participant. | Drug | A: Intervention Group - Impact®, B: Control Group - Boost® |
| Quality of life (EORTC-QLQ-30)Also: QuestionnaireParticipants will undergo pre- and post-treatment assessments. | Other | A: Intervention Group - Impact®, B: Control Group - Boost® |
| Evaluation of Cognitive Function (FACT-Cog, v. 3.0)Also: QuestionnaireParticipants will undergo pre- and post-treatment assessments. | Other | A: Intervention Group - Impact®, B: Control Group - Boost® |
| Mindfulness Questionnaire (FFMQ)Also: QuestionnaireParticipants will undergo pre- and post-treatment assessments. | Other | A: Intervention Group - Impact®, B: Control Group - Boost® |
Primary outcome
Incidence of Treatment Related Adverse Events Per Study Arm
Time frame: Up to 48 months
Overall toxicity from therapy as assessed by NCI Common Toxicity Criteria for Adverse Events (CTCAE) v. 5.0 that directly correlates with toxicity from concurrent chemoradiotherapy. Based on another randomized trial using pretreatment immunonutrition, investigators want to see if this nutritional intervention will likely decrease overall chemoradiotherapy related toxicity. All toxicity and adverse events (CTCAE v.5.0) will be assessed weekly and attributed by the treating radiation oncologist and entered into the clinical trials management database OnCore for later statistical analysis. Differences in toxicity events at the end of the study in participants receiving Impact® and those receiving Boost® will be compared using two-sample t-test.
Change in Plasma Levels of IL-6 Per Study Arm
Time frame: Up to 48 months
Measurement of the marked change of IL-6 that directly correlates with toxicity from concurrent chemoradiotherapy. Multiplex immunoassay will be used to determine the plasma levels of IL-6 in pg/ml as a continuous variable. Two-sample t-test for change in IL-6 at the last visit from the baseline will be compared between the two arms. Kolmogorove-Smirnov and Jarque-Bera tests will be performed to test for normality assumption on the primary endpoints prior to t-test analysis. If either test indicates a violation of the normality assumption, investigators will use an appropriate rank-based Wilcoxon rank-sum test instead of t-test.
4 secondary outcomes
Overall Survival (OS) 9OS)
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 2 years
Rate of Treatment Changes or Interruptions Per Study Arm
Time frame: Up to 2 years
Rate of Participant Regimen Compliance Per Study Arm
Time frame: Up to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
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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. This study is not recruiting at the moment.
Lary A. Robinson, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Impact® Advanced Recovery, Boost® High Protein and Radiation Therapy in people with Non Small Cell Lung Cancer and NSCLC, run by H. Lee Moffitt Cancer Center and Research Institute 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 9 inclusion and 12 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: withdrawn, as of the sponsor's last update on 10 Sep 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Related Adverse Events Per Study Arm (time frame: Up to 48 months). The study lists 2 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 10 Sep 2020.