A pilot randomised controlled trial of omega-3 fatty acid supplements to prevent skin cancer in lung transplant recipients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000873628

Acronym

O3 Pilot

Enrollment

Registered

2014-08-14

Start date

2014-12-15

Completion date

2015-02-26

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to evaluate the effectiveness of fish oil for the prevention of skin cancer in lung transplant recipients. Who is it for? You may be eligible to join the study if you are over 18 years of age, and are a lung transplant recipient for at least 1 year. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will take 4 x 1000mg oral capsule of omega-3 fish oil supplement daily for 12 months. Participants in the other group will take 4 x 1000mg of placebo (olive oil) daily for 12 months. Participants will not know which treatment they are taking until the end of the study. All participants will be asked to complete questionnaires, blood tests and skin exams at baseline and at the end of the study at 12 months.

Interventions

A pilot trial of a double-blind, placebo-controlled, randomized study with 2 arms. Arm1: Participants will receive 4 x 1000mg oral capsule of omega-3-acid ethyl esters 90, a fish oil supplement (Active) taken daily for 12 month Arm 2: Participants will receive 4 x 1000mg capsules of olive oil (Placebo) taken daily for 12 months. Any unused capsules will be returned to study Doctors on follow up visits.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male and female lung transplant recipients Greater than or equal to 18 years of age. 2. Greater than or equal to 1 year post lung transplant. 3. Use of systemic retinoid therapy permitted if on stable dosing for previous 3 months. 4. Will be able to attend the clinic for at least Visit 1 and Visit 4 within the recruitment timeframe.

Exclusion criteria

1. Unable to give informed consent. 2. Have innately black or dark brown skin. 3. Have a fish allergy. 4. Have a soya allergy. 5. Unable to take gelatin. 6. Have a bleeding disorder or bleeding episode in last 3 months 7. Are receiving warfarin, heparin or low molecular weight heparin in therapeutic doses. (Patients receiving heparin or low molecular weight heparin in prophylactic doses will not be excluded) 8. Are already taking fish oil supplements and unwilling to discontinue for 2 months before randomisation and for trial period. 9. Pregnant

Outcome results