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New treatment option for Lung Cancer
Official title Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease
ClinicalTrials.gov ID: NCT05986318
What this study is testing
What is Dexamethasone Oral?
Dexamethasone Oral is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for lung cancer.
Also referred to as Corticosteroid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this double-blind phase II randomized controlled trial, patients with lung cancer or ≤2 oligometastatic pulmonary lesions and a concomitant diagnosis of ILD who are planned for radical Radiation Therapy (RT) will be randomized using a 2 x 2 factorial design to oral N-acetylcysteine (NAC) versus placebo, and also to short course corticosteroids versus placebo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Lung cancer or 1-2 oligometastatic pulmonary lesions planned for radical intent radiotherapy [minimal Biologically Effective Does (BED) of 48 Gy10...
- Pathologically (histologically or cytologically) proven diagnosis of cancer is not required, but strongly recommended.
- If the risk of biopsy is unacceptable, pathologic confirmation is not required providing there is growth over time on Computed Tomography (CT)...
- Fibrotic Interstitial Lung Disease (ILD) of any subtype, as diagnosed by a respirologist and confirmed by central review
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
You likely can't join if
- Prior lung radiotherapy
- Current use of oral or intravenous corticosteroids
- Plans for the patient to receive other local therapy to the target lesion(s) while on this study, except at disease progression
- Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy
- Pregnancy
- If not pregnant, use of effective contraception methods for women of childbearing age is required which can include:
See the full eligibility criteria
- Lung cancer or 1-2 oligometastatic pulmonary lesions planned for radical intent radiotherapy [minimal Biologically Effective Does (BED) of 48 Gy10 (Gray) or biological equivalent].
- Pathologically (histologically or cytologically) proven diagnosis of cancer is not required, but strongly recommended.
- If the risk of biopsy is unacceptable, pathologic confirmation is not required providing there is growth over time on Computed Tomography (CT) imaging and/or Fluorodeoxyglucose (FDG) avidity that is strongly suggestive...
- Fibrotic Interstitial Lung Disease (ILD) of any subtype, as diagnosed by a respirologist and confirmed by central review
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- Age ≥ 18
- Life expectancy \> 6 months
- Patients are allowed to receive anti-fibrotic agents used in the treatment of Idiopathic Pulmonary Fibrosis (IPF) or non-IPF fibrotic ILD (e.g. nintedanib, pirfenidone) and/or corticosteroids, if those are part of their...
- Concurrent standard chemotherapy is allowed where indicated. All other systemic therapies, including biologic targeted agents or immunotherapy, or any drugs with known radiosensitive effects, must be stopped for 2 weeks...
- Prior lung radiotherapy
- Current use of oral or intravenous corticosteroids
- Plans for the patient to receive other local therapy to the target lesion(s) while on this study, except at disease progression
- Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy
- Pregnancy
- If not pregnant, use of effective contraception methods for women of childbearing age is required which can include:
- hormonal methods (e.g. oral, injected, implanted),
- placement of an intrauterine device,
- barrier methods (i.e. condoms),
- sterilization of the partner (e.g. previous vasectomy)
- abstinence
- Women who become pregnant should stop taking NAC and/or dexamethasone and inform their study doctor.
- Male participants should use adequate forms of birth control with their partners.
- Currently breastfeeding
- Current or recent use of NAC
- Contraindications to dexamethasone or N-Acetyl Cysteine (NAC). These include:
- Previous intolerance or allergy to dexamethasone or NAC
- Scleroderma
- Active infection
- Glaucoma
- Psychiatric disorder that could be exacerbated by dexamethasone
- Cystinuria
- Any other condition that the treating physician believes to be a contraindication to dexamethasone or NAC
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
- London, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada; London, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.