Nutritional support for patients with non-small cell lung cancer

Exploring the Effects of a Nutritional Supplement During Immunotherapy or Combination of Immunotherapy and Chemotherapy in Non-small Cell Lung Cancer Patients

This study tests if a nutritional supplement can help people with non-small cell lung cancer feel better and respond better to their cancer treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AHS Cancer Control Alberta (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT04175769 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a nutritional supplement on patients with non-small cell lung cancer who are undergoing immunotherapy or a combination of immunotherapy and chemotherapy. Participants will be randomly assigned to receive either the nutritional product or a placebo, allowing researchers to compare the outcomes between the two groups. The goal is to determine if the nutritional intervention can enhance the patients' response to their cancer treatment.

Who should consider this trial

Good fit: Ideal candidates are systemic therapy-naïve adults aged 18 and older with incurable or metastatic stage IIIB/IV non-small cell lung cancer who are willing to undergo chemotherapy or immunotherapy.

Not a fit: Patients with active malignancies requiring treatment within the last two years or those with specific genetic mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with non-small cell lung cancer by addressing nutritional deficiencies.

How similar studies have performed: While similar studies exploring nutritional interventions in cancer treatment exist, this specific approach is relatively novel.

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

Where this trial is running

Edmonton, Alberta

• Cross Cancer Institute — Edmonton, Alberta, Canada (Recruiting)

Study contacts

• Study coordinator: Quicy Chu, MD, FRCP (C)

Conditions Non-small Cell Lung Cancer