Health Trials

Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease

ConditionsLung CancerInterstitial Lung Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Palma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 of malignancy.

Fibrotic Interstitial Lung Disease (ILD) of any subtype, as diagnosed by a respirologist and confirmed by central review

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • N-Acetyl cysteine

    Dietary supplement

    NAC capsules

  • Dexamethasone Oral

    Drug

    Dexamethasone tablets

  • N-Acetyl cysteine Placebo

    Dietary supplement

    Matching placebo for NAC capsules

  • Dexamethasone Placebo

    Drug

    Matching placebo for dexamethasone tablets

  • Radiation Therapy

    Radiation

    All participants will receive radical pulmonary radiation therapy. Conventional techniques or stereotactic ablative radiotherapy will be used.

Treatment groups

98 Participants
are divided into 4 treatment groups
Group A: NAC + CorticosteroidsActive comparator 3 interventions
Group B: Corticosteroids + NAC PlaceboActive comparator 3 interventions
Group C: NAC + Dexamethasone PlaceboActive comparator 3 interventions
Group D: NAC Placebo + Dexamethasone PlaceboPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Rate of Grade 2-5 Dyspnea within 6 Months Post Radiation Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5

Time frame
Up to 6 months post radiation therapy

Secondary outcomes

1

Patient Scored Dyspnea Measured by Visual Analogue Scale (VAS)

Dyspnea (shortness of breath) severity will be reported by participants via a scale, where a score of 100 is no shortness of breath and a score of 0 is the worst shortness of breath ever.

Time frame
6 weeks, 3, 6, 9, 12,18, 24, 36, 48, and 60 months post radiation therapy
2

Patient Scored Cough Measured by Visual Analogue Scale (VAS)

Cough severity will be reported by participants via a scale, where a score of 100 is no cough and a score of 0 is the worst cough ever.

Time frame
6 weeks, 3, 6, 9, 12,18, 24, 36, 48, and 60 months post radiation therapy
3

Quality of Life Measured by FACIT.org Functional Assessment of Cancer Therapy - Lung (FACT-L) Questionnaire

The Functional Assessment of Cancer Therapy - Lung (FACT-L ) is a standardized questionnaire used to measure quality of life. The questionnaire consists of 5 scales measuring 37 items in total. Categories of the 5 scales are: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns related to symptoms, cognitive function, and regret of smoking. The score for each item in the scale ranges from 0 to 4, where 0 is not at all and 4 is very much. The scores from each scale are added up, and can be combined to provide a total score.

Time frame
6 weeks, 3, 6, 9, 12,18, 24, 36, 48, and 60 months post radiation therapy
4

Quality of Life Measured by EuroQOL Group EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized questionnaire used to measure quality of life and health. The first section includes 5 categories: mobility, self-care, usual activities (e.g. work, family), pain/discomfort, and anxiety/depression. Each category contains 5 statements ranging from no problems to extreme problems, where no problems is assigned a code of 1 and extreme problems is assigned a code of 5. Participants are asked to select the statement that best describes their health that day. No score is generated, rather a 5 digit code is generated based on the response provided, which can then be combined into a data set and interpreted in a variety of ways. The second section includes a 20 cm analogue scale from 0 to 100, where 100 is the best health ever imagined and 0 is the worst health imagined. The participant will mark a score on the scale representing the state of their health on that day.

Time frame
6 weeks, 3, 6, 9, 12,18, 24, 36, 48, and 60 months post radiation therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Palma

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor institution

London Health Sciences Centre

Collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Source ClinicalTrials.gov
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