Clinical trial NCT05404022: Feasibility Trial of a Personalised Nutrition and Activity Programme for People With Lung Cancer Over 65 Years
Official title: Cancer Behavioural Nutrition and Exercise Feasibility Trial - Phase II Randomised Controlled Trial Among Older Adults With Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasm Malignant
Mesothelioma; Lung
Keywords: Physical Activity
Nutrition
Feasibility RCT
Lung cancer
Older adults
Lead sponsor: University of Hull
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 11
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: People with cancer affecting the lungs tend to be older and frailer compared to people with other cancers. As a result, they may have poorer quality of life and are less able to tolerate treatments for their cancer, such as chemotherapy. Research to date show that nutrition and physical activity support helps people with cancer, but not many older people are included in these studies.

The investigators want to develop and test a nutrition and activity programme for older people with lung cancer that can be tailored to each patient to help them have the best possible quality of life from the moment they start a new line of cancer treatment.

The research team has conducted the development work to find which nutrition and activity programmes are best for this patient group and how best to deliver the programme by looking at prior studies and talking to patients and carers as well as health care providers.

The next step is to test the developed programme in a small pilot study, to i) see if it is possible and acceptable (to patients, families, and staff) to deliver and ii) see if it helps patients have and cope with anti-cancer treatments and improve patient quality of life.

Detailed description: BACKGROUND

Lung cancer is the third most commonly diagnosed cancer in the UK and most common in Yorkshire. It is also the most common cause of cancer death in UK. People with lung cancer are often older with co-morbidities and frailty resulting in a poor prognosis - especially if they are unfit for treatment. Approximately half of new cancer cases in UK are people aged 65 and over. Frailty, with sarcopenia (age-related decline in skeletal muscle), cachexia (disease-related body wasting) and nutritional deficiencies, may limit chemotherapy options, reduce treatment effectiveness, result in dose reductions and poor treatment completion rates.

Physical activity (PA) interventions benefit people living with or beyond cancer by improving physical function and quality of life (QoL) during and after cancer treatment. Reduced physical function is associated with higher mortality in older adults with cancer.PA improves treatment completion, treatment recovery, survival rates and reduces healthcare use. Emerging work indicates that activity improves immune function in older adults with cancer; important as better immune function has been linked to improved treatment outcomes. A recent meta-analysis shows reduced risk of cancer-specific and all-cause mortality for those more active among people with lung cancer.

Weight loss and poor nutrition may prevent patients from completing cancer treatments and increase the risk and severity of treatment toxicity. In those receiving chemotherapy, better nutritional status is associated with improved survival and, in lung cancer patients undergoing chemotherapy, better QoL. Cancer treatments can cause many side-effects that impact eating, including; fatigue, nausea, vomiting, dry mouth/oral candidiasis, disordered taste, ill-fitting dentures, diarrhoea, constipation, oesophagitis, early satiety and poor appetite; all difficult for patients to self-manage. Nutritional interventions, including dietary counselling and nutrition advice, improve patient wellbeing and rate of treatment completion. Despite the urgent need for improvements in survival outcomes for older people with lung cancer, a significant evidence gap remains regarding nutrition.

This team's systematic review highlighted the lack of PA and nutrition programme research for older adults living with and beyond cancer. Studies including older adults often focus on prostate cancer, generally a group with a better prognosis. Therefore, many older adults with other cancers, such as lung cancer (only one study in our review), are not represented. Qualitative interviews with patients, carers, and clinicians in Hull (with experience of lung cancer) confirmed poor access to, but support for and interest in, wellbeing interventions but only if tailored to their needs - including management of activity-related breathlessness.

A tailored wellbeing intervention, designed to improve or maintain physical function via lifestyle behaviours, may decrease older adults with lung cancer needing dose reductions. Dose intensity is significantly associated with mortality among people receiving treatment for lung cancer. By maintaining physical function/nutrition, people can tolerate more treatment with subsequent better overall survival. This could be very significant among people diagnosed with lung cancer, a cancer with generally poor prognosis.

Therefore, the aim of this study is to investigate the feasibility and acceptability of conducting a future definitive trial of a tailored wellbeing (nutrition and activity) programme for older adults with lung cancers who are starting a new line of systemic anticancer therapy.

AIMS AND OBJECTIVES

Primary aim/objective

To determine the feasibility and acceptability of a tailored wellbeing (nutrition and activity) programme for older adults with lung cancer beginning a new line of systemic anti-cancer therapy in terms of recruitment, intervention delivery, appropriateness of candidate primary outcomes, estimated sample size for a future phase III trial.

Secondary aims/objectives

To assess data quality

1. QoL\* and QoL adjusted days alive out of hospital\*
2. treatment dose intensity\*
3. episodes of infection
4. fatigue
5. functional status

To assess participant/clinician acceptability and experience

\*candidate primary outcomes for subsequent trial

Eligibility criteria: Inclusion Criteria:

1. age ≥65 years,
2. diagnosed with stage III or IV lung cancer or mesothelioma,
3. starting a new line of systemic anti-cancer treatment,
4. willing and able to complete study measures and be randomised
5. able to provide informed written or verbal witnessed consent

Exclusion Criteria:

1. Patients receiving radical chemoradiation therapy (potentially curative and require parental feeding)
2. Have had more than one dose of new treatment.
3. Unstable acute condition (e.g., acute infection, severe uncontrolled symptoms) or
4. Underlying chronic condition (e.g., severe arthritis or dementia) that would impact study compliance.
5. Unable to provide written or verbal consent.
6. Insufficient English for consent and study procedures and appropriate interpretation unavailable

Primary outcomes:
measure: Recruitment Rate
timeFrame: 24 weeks
measure: Retention Rate
timeFrame: 24 weeks
measure: Secondary outcome data completion rate
timeFrame: 24 weeks
measure: Rate of Intervention Completion
timeFrame: 12 weeks
measure: Incidence of adverse effects and injuries related to the intervention
timeFrame: Week 1 to week 12
measure: Incidence of adverse events not related to the intervention
timeFrame: Week 1 to week 52
Secondary outcomes:
measure: Free-living daily activity
timeFrame: Baseline, 24 weeks
measure: Australian Karnofsky Performance Scale (AKPS)
timeFrame: baseline, 12 and 24 weeks
measure: Rockwood Frailty Index, a 7-point Clinical Frailty Scale
timeFrame: baseline, 12 and 24 weeks
measure: Short Physical Performance Battery (SPBB)
timeFrame: baseline, 12 and 24 weeks
measure: Grip strength
timeFrame: baseline, 12 and 24 weeks
measure: Bioelectrical impedance
timeFrame: baseline, 12 and 24 weeks
measure: Weight (kg)
timeFrame: baseline, 12 and 24 weeks
measure: Patient-Generated Subjective Global Assessment (PG-SGA)
timeFrame: baseline and after 6, 12, and 24 weeks
measure: Community Healthy Activities Model Program for Seniors (CHAMPS)
timeFrame: baseline and after 6, 12, and 24 weeks
measure: Integrated Patient Outcome Scale (IPOS)
timeFrame: baseline and after 6, 12, and 24 weeks
measure: Client Service Receipt Inventory
timeFrame: baseline and after 6, 12, and 24 weeks
measure: EuroQol-5 Dimensions-5 Levels
timeFrame: baseline and after 6, 12, and 24 weeks
measure: EuroQol-Visual Analogue Scale
timeFrame: baseline and after 6, 12, and 24 weeks
measure: Days alive and out of hospital
timeFrame: baseline, and after 6, 12, and 24 weeks
measure: Treatment completion rate
timeFrame: baseline, and after 6, 12, and 24 weeks
measure: Infection rate
timeFrame: baseline, and after 6, 12, and 24 weeks
measure: Treatment toxicity
timeFrame: baseline, and after 6, 12, and 24 weeks
measure: Height
timeFrame: baseline, 12 and 24 weeks
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
state: Yorkshire
city: York
country: United Kingdom
facility: York and Scarborough Teaching Hospitals NHS Trust
state: Yorkshire
Study officials:
affiliation: Hull York Medical School, University of Hull
name: Cynthia Forbes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swan F, Chen H, Forbes CC, Johnson MJ, Lind M. CANcer BEhavioural nutrition and exercise feasibility trial (CanBenefit); phase I qualitative interview findings. J Geriatr Oncol. 2021 May;12(4):641-648. doi: 10.1016/j.jgo.2020.09.026. Epub 2020 Oct 12.
citation: Forbes CC, Swan F, Greenley SL, Lind M, Johnson MJ. Physical activity and nutrition interventions for older adults with cancer: a systematic review. J Cancer Surviv. 2020 Oct;14(5):689-711. doi: 10.1007/s11764-020-00883-x. Epub 2020 Apr 24.