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Clinical Trials/ISRCTN73427832
ISRCTN73427832Active, not recruitingUnknown

KETO-Lung: Assessing the impact of the adoption of a continuous ketogenic diet therapy on the efficacy of combination chemo-immunotherapy using paclitaxel/carboplatin/pembrolizumab in advanced squamous cell cancer of the lung

niversity of Birmingham0 sites48 target enrollmentStarted: July 15, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Unknown
Status
Active, not recruiting
Enrollment
48
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Histologically proven locally advanced or metastatic squamous cell lung cancer not amenable to definitive local therapy and suitable for first-line systemic therapy of chemo-immunotherapy (paclitaxel, carboplatin, pembrolizumab)
  • •2. Aged 16 years or older
  • •3. Willing to undertake dietary modification for up to 12 weeks (+ 1 week introductory period)
  • •4. Willing to self-monitor blood glucose and ketones daily and feedback/discuss weekly
  • •5. Life expectancy greater than trial treatment period >12 weeks
  • •6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 with no deterioration over the previous 2 weeks
  • •7. Disease measurable according to RECIST v1.1
  • •8. Disease amenable to biopsy for metabolic studies
  • •9. Adequate haematological function within 7 days of treatment
  • •9.1. Haemoglobin > = 100 g/L
  • •9.2. Absolute neutrophil count (ANC) > = 1.5 x 10^9/L
  • •9.3. Platelet count > = 100 x 10^9/L
  • •10. Adequate hepatic function within 7 days of treatment:
  • •10.1. Total serum bilirubin < = 1.5 x upper limit of normal (ULN)
  • •10.2. Alanine transferase (ALT) < = 2.5 x ULN.
  • •10.3. Aspartate transferase (AST) < = 2.5 x ULN
  • •11. Adequate renal function within 7 days of treatment:
  • •11.1. Creatinine clearance <1.5 times ULN concurrent with creatine clearance >50 ml/min (calculated by Cockcroft and Gault equation). If this is <=50 ml/min then an isotopic Glomerular Filtration Rate (GFR) may be carried out and must be >50 ml/min
  • •12. Willing to accept paired biopsies at week 5 and blood samples at pre- and post- 12 weeks KDT treatment for translational metabolic analyses
  • •13. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal participants
  • •14. Male and female participants of childbearing potential willing to use highly effective contraception
  • •15. Willing and able to comply with scheduled visits, treatment plan and other trial procedures
  • •16. Willing and able to give written informed consent for the trial

Exclusion Criteria

  • •1. Patients who do not meet the criteria of performance status <=1 on the ECOG Performance scale i.e. patients that are not be ambulatory and able to carry out work of a light or sedentary nature e.g. light housework, office work
  • •2. Untreated symptomatic brain or leptomeningeal metastatic disease
  • •3. Medical or psychiatric conditions compromising informed consent
  • •4. Any pre-existing autoimmune disease besides well-controlled thyroid disease
  • •5. Patients with active concurrent cancer or cancer within the past 3 years excepting non-melanomatous skin cancer and in situ cancers
  • •6. Anyone diagnosed with fatty acid oxidation defects, organic acidurias (organic acid disorders), pyruvate carboxylase deficiency, porphyria or other disorders requiring a high carbohydrate treatment
  • •7. Anyone who knows they respond to fasting by becoming significantly unwell or unconscious
  • •8. Any disorder affecting the ability to eat or digest food; swallowing problems, digestive or reflux issues or difficulties with the bowel such as chronic constipation or diarrhoea
  • •9. Patients requiring regular steroid therapy with steroids at a dose higher than prednisolone 10 mg/day or equivalent
  • •10. History of anorexia
  • •11. Diabetes on medication (Type 2 on oral medication - adjustment needed. Type 1 – not appropriate for trial)
  • •12. Familial hyperlipidaemia
  • •13. Acute pancreatitis or history of pancreatitis
  • •14. Patients with a current or recent history of clinically significant renal, cardiac, hepatic, haematological, pulmonary, gastroenterological, cerebrovascular or neurological disease as determined by the investigator
  • •15. Patients with a history of organ transplant including Allogeneic Stem Cell Transplantation (allo-SCT)
  • •16. Patients with superior vena cava syndrome
  • •17. No contraindications to anti-PD1 therapy or KDT, such as metabolic disorders
  • •18. Carnitine deficiency (primary) and carnitine palmitoyltransferase I or II deficiency (myopathic form may present in adolescence) or carnitine translocase deficiency
  • •19. Previous cholecystectomy
  • •20. Osteopenia or osteoporosis
  • •21. Corrected calcium > ULN within 7 days of treatment
  • •21.1. Corr. Calcium = Total Calcium (mmol/L) + ([40 – Albumin (G/L)] x 0.02)
  • •22. Phosphate > ULN within 7 days of treatment
  • •23. Hepatic function (in patients with liver metastasis)
  • •23.1. Alanine transferase (ALT) and Aspartate transferase (AST) >5 x ULN
  • •24. Patient is positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA (qualitative) is detected); patients with negative Hepatitis C antibody testing may not need RNA testing
  • •25. Known history of tuberculosis
  • •26. Female patients of childbearing potential should be using adequate contraceptive measures, should not be breastfeeding and must have a negative pregnancy test prior to the start of treatment. Pregnant patients will be ineligible
  • •27. Patient has an active infection requiring therapy
  • •28. Patient is, at the time of signing informed consent, a regular user (including recreational use”) of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol)
  • •29. Participation in another therapeutic clinical trial whilst taking part in this trial
  • •30. Any psychological, familial, sociological or geographical condition hampering protocol compliance
  • •31. Any medical condition which in the opinion of the Investigator would compromise the ability of the patient to participate in the trial or which wo

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