A Nutritional Supplement to Support People With Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Other: PlaceboDietary Supplement: Nutritional supplement
- Registration Number
- NCT04175769
- Lead Sponsor
- AHS Cancer Control Alberta
- Brief Summary
People with non-small cell lung cancer are at risk for nutritional deficiencies.
The purpose of this study is to find out what effects a nutritional product has on patient's response to immunotherapy or combination of immunotherapy and chemotherapy. To do this, some of the participants will get the nutritional product and some will receive a placebo (a substance that looks like the study drug but does not have any active or medicinal ingredients). A placebo is used to make the results of the study more reliable.
Participants will be randomized to any of the following treatment groups:
- Group 1 (Experimental intervention): standard intervention of immunotherapy or combination of immunotherapy and chemotherapy plus the experimental intervention nutritional product.
Group 2 (Non-experimental intervention): standard intervention of immunotherapy or combination of immunotherapy and chemotherapy plus the non-experimental intervention placebo product.
Participants will take 5 capsules each day by mouth, starting on the first day of immunotherapy with or without chemotherapy and stopping upon completion of their immunotherapy with or without chemotherapy treatment.
Participants will complete a diary of their nutritional/ placebo product intake and will undergo the following assessments:
* Physical examination.
* Height and weight.
* ECOG status (the physician will record the impact on the cancer on daily living abilities).
* Concomitant medications recording.
* Adverse Event Assessment
* Computed tomography (CT) scan. A series of x-rays of the body from many angles that are turned into 3-dimensional pictures on a screen.
* Quality of life questionnaires.
* Blood collection
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-experimental intervention Placebo Standard intervention of immunotherapy or combination of immunotherapy and chemotherapy, plus the non-experimental intervention placebo product. Experimental intervention Nutritional supplement Standard intervention of immunotherapy or combination of immunotherapy and chemotherapy, plus the experimental intervention nutritional product.
- Primary Outcome Measures
Name Time Method Disease control rate Upon completion of 4 cycles of treatment (each cycle is 21-days) Disease control rate is defined as the sum of patients with a complete response, partial response or stable disease via RECIST v.1.1 or iRECIST after 4-cycles of immunotherapy or a combination of chemotherapy and immunotherapy.
- Secondary Outcome Measures
Name Time Method Change in skeletal muscle mass and adipose tissue Upon completion of 4 cycles of chemotherapy (each cycle is 21 days) Changes in cross-sectional areas of skeletal muscle will determined using two consecutive CT images from the third lumbar vertebrae region and normalized for stature (cm²/m²).
Change in Serum CRP Upon completion of 4 cycles of chemotherapy (each cycle is 21 days) Serum CRP will be determined using enzyme-linked immunosorbent assays.
Changes in Quality of Life via Taste and Smell Survey Questionnaire will be administered at cycle 1 day 1, cycle 3 day 1 (each cycle is 21 days) and at the end of treatment (within 30 days of last dose). The Taste and Smell Survey v29Oct2015 will be administered at cycle 1, 3 and at the end of treatment visit. The questionnaire will be scored according to the scoring manual, and changes analyzed to asses the effect of the investigational product on quality of life during treatment.
Systemic therapy-induced toxicities On day 1 of each treatment cycle (each cycle is 21 days) and at the end of treatment visit (within 30 days of last dose) Toxicity will be assessed and graded using the National Cancer Institute CTCAE, version 5.0.
1-year survival Analysis will occur once 1-year survival data has been collected for all study participants. 1-year survival (or death before 1-year)
Change in Fatty Acid Incorporation and Omega-3 Index On day 1 of each treatment cycle (each cycle is 21 days) and at the end of treatment visit (within 30 days of last dose) A phospholipid analysis will be performed on blood samples collected prior to treatment on day 1 of cycles 1-4 and the end of treatment visit. Omega 3-Index will be calculated from the results of the phospholipid analysis.
Disease Control Rate after 2 cycles Upon completion of 2 cycles of treatment (each cycle is 21-days) Disease control rate is defined as the sum of patients with a complete response, partial response or stable disease after 2 cycles of systemic therapy divided by the number of patients in the group. The Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or iRECIST will be used as the standardized tumor response assessment on CT images.
Progression-free survival Analysis will occur once 1-year survival data has been collected for all study participants. Defined as the time from treatment to time of documented disease progression or death. The RECIST v 1.1 or iRECIST will be used as the standardized tumor response assessment on CT images to determine disease progression.
Change in Serum Albumin Upon completion of 4 cycles of chemotherapy (each cycle is 21 days) Serum albumin will be determined using enzyme-linked immunosorbent assays.
Changes in Quality of Life via PROMIS Global Health Scale Questionnaire will be administered at cycle 1 day 1, cycle 3 day 1 (each cycle is 21 days) and at the end of treatment (within 30 days of last dose). The PROMIS Global Health Scale v1.2 will be administered at cycle 1, 3 and at the end of treatment visit. The questionnaire will be scored according to the scoring manual, and changes analyzed to asses the effect of the investigational product on quality of life during treatment.
Changes in Quality of Life via FAACT Questionnaire will be administered at cycle 1 day 1, cycle 3 day 1 (each cycle is 21 days) and at the end of treatment (within 30 days of last dose). The Functional Assessment of Anorexia Cachexia (FAACT) form version 4 will be administered at cycle 1, 3 and at the end of treatment visit. The questionnaire will be scored according to the scoring manual, and changes analyzed to asses the effect of the investigational product on quality of life during treatment.
Changes in Quality of Life via PROMIS Physical Function Short Form Questionnaire will be administered at cycle 1 day 1, cycle 3 day 1 (each cycle is 21 days) and at the end of treatment (within 30 days of last dose). The PROMIS Physical Function form v2.0 will be administered at cycle 1, 3 and at the end of treatment visit. The questionnaire will be scored according to the scoring manual, and changes analyzed to asses the effect of the investigational product on quality of life during treatment.
Trial Locations
- Locations (1)
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada