Pregabalin for chronic cough in patients with lung cancer

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Age 18 years or older.

2.Locally advanced or metastatic suspected or

diagnosed NSCLC.

3.Eastern Cooperative Group performance status

between 0 and 2.

4.Moderate (grade 2) or severe (grade 3) cough

that has lasted for 2 or more weeks. Cough

severity will be according to the Common

Terminology Criteria for Adverse Events

(CTCAE), v.5, in which grade 2 signifies

moderate symptoms, medical intervention

required, limiting instrumental activities of

daily living; and grade 3 cough signifies

severe symptoms limiting self-care activities

of daily living.

5.Willing and able to limit to one alcoholic

beverage per day (e.g. 360 ml of beer or 120

ml of wine or 330 ml of cooler or 43 ml of

hard liquor like whisky/ vodka/ rum/ gin).

6.Creatinine clearance measured by the

Cockcroft-Gault formula > 60 ml/min.

7.Women of childbearing potential must be

willing to consent to using effective

contraception (e.g.,hormonal contraceptives,

bilateral tubal ligation, barrier with

spermicide, intrauterine device) while on

treatment and for at least 3 months

thereafter. A man who is the partner of a

woman of childbearing potential must be

willing to consent to using effective

contraception (e.g., vasectomy or barrier

with spermicide) while on treatment and for 3

months thereafter.

8.Capable of providing informed consent and

follow trial procedures.

Exclusion Criteria

1.Patients already receiving pregabalin or

gabapentin, irrespective of indication, at the

time of screening.

2.Known hypersensitivity to pregabalin or

gabapentin or their components.

3.Pregnancy or breast feeding.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of Pregabalin[max dose 300mg] on cough severity as measured by the Visual Analog Scale(VAS)Timepoint: Between Baseline & 9 Weeks of treatment

Secondary Outcome Measures

Name	Time	Method
1.To assess the effect of Pregabalin[max dose 300mg] on cough severity as measured by the Manchester Cough in Lung Cancer Scale (MCLCS) score <br/ ><br>2.Change in VAS and MCLCS scores between baseline and day 7 of therapy with pregabalin(maximal tolerable dose of 300 mg per day) as compared to matching placebo. <br/ ><br>3.Quality of Life <br/ ><br>4.Adverse effects of pregabalinTimepoint: 1.Between Baseline & 9 Weeks of treatment <br/ ><br>2.Basline & day7 in both arms <br/ ><br>3.Baseline & Day 7 & At 9 weeks (End of Treatment) <br/ ><br>4.Each visit