None listed
Conditions
Brief summary
This study aims to find out if dietary counselling before, during and after your upcoming (chemo)radiotherapy treatment helps to reduce weight loss and improve functioning and fatigue levels. It will also explore if this improves quality of life, severity of treatment symptoms, the number of unexpected admissions to hospital, interruptions to your treatment, response to cancer treatment and survival after treatment. Who is it for? You may be eligible for this study if you are over 18 years of age and due to undergo radiotherapy with or without chemotherapy for non-small cell or small cell lung cancer. Patients with lung cancer are at risk of developing side effects from (chemo)radiotherapy treatment that affect their ability to eat adequately and place them at risk of developing malnutrition. Up to 33% of patient with lung cancer may be malnourished before starting (chemo)radiotherapy and this can increase to 50% after radiotherapy is completed. Patients who are malnourished or underweight have more complications, more symptoms, poorer quality of life, more treatment interruptions, poorer response to cancer treatment and don't survive as long after treatment. Previous research has demonstrated that patients with head and neck and gastrointestinal cancer who received dietary counselling from a dietitian during and after (chemo)radiation lose less weight, have a better quality of life and functioning, and colorectal cancer patients who received dietary counselling survived longer after treatment. Providing dietary counselling from a dietitian during (chemo)radiotherapy treatment for lung cancer has never been tested. Trial Details: You will be randomised to one of two treatment arms, either a medical nutrition therapy arm or usual care. The medical nutrition therapy arm consists of individualised one-on-one dietary counselling in person or over the phone once before treatment starts, weekly during treatment and fortnightly for 6 weeks after treatment. The usual care arm will receive dietary counselling but less frequently and starting during treatment instead of before treatment. The results of this study will be incorporated into existing evidence based guidelines for the nutritional management of patients receiving radiation therapy. These guidelines are used by dietitians and other health professional to provide the best nutritional care to cancer patients.
Interventions
Medical nutrition therapy. This will involve indivualised one-on-one dietary counselling in person or over the phone by a dietitian once prior to starting (chemo)radiotherapy, weekly during treatment and fortnightly for 6 weeks after treatment. Each session will be between 15 to 30 minutes duration depending on the degree of nutritional issues identified. The average length of the intervention period is 14 weeks.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undergoing radical radiotherapy with or without chemotherapy for a primary diagnosis of non-small cell or small cell lung cancer. Patients who are over 18 years of age.
Exclusion criteria
Patients being treated with palliative intent. Patients receving induction chemotherapy prior to (chemo)radiation treatment. Patients with small peripheral tumours and no mediastinal disease. Patients having twice daily radiotherapy. Patients who are non-English speaking. Patients with a cognitive impairment or psychiatric illness.
Outcome results
None listed