Clinical trial NCT04175769: A Nutritional Supplement to Support People With Non-small Cell Lung Cancer
Official title: Exploring the Effects of a Nutritional Supplement During Immunotherapy or Combination of Immunotherapy and Chemotherapy in Non-small Cell Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-small Cell Lung Cancer
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Subject inclusion criteria

1. 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. Patients who have received prior platinum-based chemotherapy +/- immunotherapy in the curative setting will be allowed to enroll as long as the curative therapy ended at least 12 months prior to enrolment.
2. Age \> or = 18 years.
3. A diagnostic CT image taken with a maximum of 60 days before initiation of systemic therapy.
4. An Eastern Cooperative Oncology Group Performance Status of ≤ 2.
5. Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.

Subject exclusion criteria.

1. Prior other malignancy, active (i.e., requiring treatment or intervention) within the previous 2 years, except for locally curable malignancies that have been apparently cured, which are allowed, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
2. Life expectancy \<6 months at the discretion of the treating physician
3. Patients currently taking a supplement containing the nutritional supplement under study. Patients should have stopped taking supplements containing the nutritional supplement under study at least 30 days prior to enrolment.
4. A known hypersensitivity / allergy to the investigational product, placebo or to any ingredient in their formulations (e.g. gelatin or glycerin).
5. Enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.
6. Weight loss \>10% over past 6 months (weight 6 months ago minus weight today, divided by weight 6 months ago) x 100 = weight loss%.
7. Blood transfusions within 2 weeks of blood collection for the trial.
8. Untreated brain metastases (patients with previously resected and/or radiated brain metastases without neurologic symptoms are permitted).
9. Subject requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to study drug administration. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone, 2 mg per day of dexamethasone or up to 10 mg per day of prednisone) are allowed. Patients may take corticosteroids for ≤4 days as part of routine cancer-directed therapy prophylaxis (e.g., chemotherapy-induced nausea and vomiting).
10. Active autoimmune disease. Subjects with type 1 diabetes mellitus, stable endocrinopathies maintained on appropriate replacement therapy and skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring systemic treatment are allowed.
11. Uncontrolled diabetes, i.e. with random blood glucose \>15.0 mmol/L.
12. Current or expected difficulty or inability to swallow capsules.
13. Use of non-steroidal anti-inflammatory drugs (NSAIDs) for ≥7 consecutive days. Patients are allowed to receive single doses of NSAIDs and may take daily 81 mg ASA.
14. In the investigators' opinion, patients who have medical conditions that could interfere with drug metabolism or absorption (e.g., short bowel syndrome, history of small bowel obstruction, Crohn's disease, etc.)
15. Serum albumin \<35 g/L

Primary outcomes:
measure: Disease control rate
timeFrame: Upon completion of 4 cycles of treatment (each cycle is 21-days)
Secondary outcomes:
measure: Progression-free survival
timeFrame: Analysis will occur once 1-year survival data has been collected for all study participants.
measure: 1-year survival
timeFrame: Analysis will occur once 1-year survival data has been collected for all study participants.
measure: Systemic therapy-induced toxicities
timeFrame: 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)
measure: Change in skeletal muscle mass and adipose tissue
timeFrame: Upon completion of 4 cycles of chemotherapy (each cycle is 21 days)
measure: Change in Serum CRP
timeFrame: Upon completion of 4 cycles of chemotherapy (each cycle is 21 days)
measure: Change in Serum Albumin
timeFrame: Upon completion of 4 cycles of chemotherapy (each cycle is 21 days)
measure: Change in Fatty Acid Incorporation and Omega-3 Index
timeFrame: 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)
measure: Changes in Quality of Life via PROMIS Global Health Scale
timeFrame: 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).
measure: Changes in Quality of Life via PROMIS Physical Function Short Form
timeFrame: 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).
measure: Changes in Quality of Life via FAACT
timeFrame: 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).
measure: Changes in Quality of Life via Taste and Smell Survey
timeFrame: 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).
measure: Disease Control Rate after 2 cycles
timeFrame: Upon completion of 2 cycles of treatment (each cycle is 21-days)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
References: