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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Systemic therapy-naïve patients with a histologically confirmed diagnosis of incurable or metastatic stage IIIB/IV non-small cell lung cancer with no EGFR and ALK mutation, who have agreed to receive chemotherapy or both immunotherapy and chemotherapy
Age > or = 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up analysis will occur once 1-year survival data has been collected for all study participants.
Awards & highlights
Study Summary
This trial is looking at whether a nutritional product has an effect on patients with non-small cell lung cancer who are also receiving immunotherapy or a combination of immunotherapy and chemotherapy.
Who is the study for?
Adults over 18 with stage IIIB/IV non-small cell lung cancer without certain mutations, who've finished curative therapy at least a year ago and are starting chemotherapy or immunotherapy. They must be able to swallow capsules, have no severe allergies to the trial's ingredients, controlled diabetes, no recent blood transfusions or other malignancies within two years (except some cured skin cancers), and not be on conflicting treatments.Check my eligibility
What is being tested?
The trial is testing if a nutritional supplement can improve responses to standard lung cancer treatments. Participants will either receive this supplement or a placebo alongside their regular treatment of immunotherapy or chemotherapy. They'll take five capsules daily from the start of their treatment until it ends and keep track of intake in a diary.See study design
What are the potential side effects?
Potential side effects aren't specified for the nutritional supplement but may include typical reactions to supplements such as digestive discomfort. The study will monitor any adverse events throughout.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have advanced lung cancer without EGFR or ALK mutations and agree to chemotherapy or immunotherapy.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ analysis will occur once 1-year survival data has been collected for all study participants.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~analysis will occur once 1-year survival data has been collected for all study participants.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control rate
Secondary outcome measures
1-year survival
Change in Fatty Acid Incorporation and Omega-3 Index
Change in Serum Albumin
+9 moreSide effects data
From 2008 Phase 4 trial • 300 Patients • NCT008760188%
Fever
2%
Vomiting
2%
Skin allergy
2%
Tooth ache
1%
Abrasion
1%
Excessive tiredness after 20m shuttle
1%
Fall/Fracture
1%
Leg wound
1%
Abrasion during 20 m shuttle
1%
Felt dizzy after blood collection
1%
Urinary tract infection
1%
Chicken pox
1%
Respiratory tract infection
1%
Ear/leg pain
1%
Perianal abscess
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group A (Unfortified Nutritional Powder)
Experimental Group (Fortified Nutritional Supplement)
Control Group B (No Intervention)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental interventionExperimental Treatment1 Intervention
Standard intervention of immunotherapy or combination of immunotherapy and chemotherapy, plus the experimental intervention nutritional product.
Group II: Non-experimental interventionPlacebo Group1 Intervention
Standard intervention of immunotherapy or combination of immunotherapy and chemotherapy, plus the non-experimental intervention placebo product.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nutritional supplement
2011
Completed Phase 4
~480
Find a Location
Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,152 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood has low levels of albumin (a type of protein).I haven't had any cancer needing treatment in the last 2 years, except for minor skin, bladder, cervix, or breast cancers that were cured.I have advanced lung cancer without EGFR or ALK mutations and agree to chemotherapy or immunotherapy.I have not taken strong immune system suppressing drugs in the last 14 days, except for low-dose steroids or short-term corticosteroids for treatment side effects.I have an autoimmune disease but it's either type 1 diabetes, a stable hormone issue treated with medication, or a skin condition not needing systemic treatment.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.I finished platinum-based chemo or immunotherapy for cure over a year ago.You have trouble swallowing capsules or are expected to have trouble swallowing them.I have had brain metastases treated and have no neurological symptoms.I stopped taking supplements with the study's nutrient at least 30 days ago.I have lost more than 10% of my weight in the past 6 months.You had a CT scan within the last 60 days before starting treatment.Your diabetes is not well controlled, and your random blood sugar level is higher than 15.0 mmol/L.I have not had a blood transfusion in the last 2 weeks.Your doctor believes you may have less than 6 months to live.I don't have conditions that affect drug metabolism or absorption.I have been taking NSAIDs for at least 7 days in a row.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental intervention
- Group 2: Non-experimental intervention
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still happening for this experiment?
"Affirmative, according to clinicaltrials.gov the study is looking for 60 volunteers and was posted on November 30th 2022 with a final edit made on December 1st 2022. The research will be conducted in one medical facility."
Answered by AI
How many participants are participating in this clinical research?
"Affirmative. According to the information located on clinicaltrials.gov, recruitment for this medical trial is ongoing since its inception on November 30th 2022 and last update December 1st of that year. 60 participants are sought after at a single site."
Answered by AI
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