Skip to main content
OpenTrials
Completed

NCT Number: NCT05404022

Feasibility Trial of a Personalised Nutrition and Activity Programme for People With Lung Cancer Over 65 Years

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Neoplasm Malignant Adenoma Behavior Lung Diseases Lung Neoplasms Mesothelioma Mesothelioma; Lung Motor Activity Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hull University Teaching Hospitals NHS Trust, Hull, Yorkshire, United Kingdom

Loading trial locations.

About this study

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

  • QoL* and QoL adjusted days alive out of hospital*
  • treatment dose intensity*
  • episodes of infection
  • fatigue
  • functional status

To assess participant/clinician acceptability and experience

*candidate primary outcomes for subsequent trial

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Tailored nutrition and physical activity programme

Other

Physical activity prescriptions will follow recent guidance for people with cancer and the FITT principles: Frequency (weekly sessions), Intensity (how hard), Time (session duration), and Type. Programme content, duration, and intensity will be tailored for comorbidities and other limitations.

Nutrition prescription may include any or all of the following:

  • Information on side-effects that may affect eating and their mitigation
  • Feedback on physical measures (weight loss) in relation to nutrition and treatment outcomes
  • Feedback on assessment of food intake and how to improve
  • a Macmillan booklet: advice on eating and maintaining weight throughout cancer treatments.
  • a recipe book "Making the most of every bite"
  • tailored oral nutritional support, including use of high calorie/protein nutrition supplementation, or other macro and micronutrient supplementation as required

Primary outcomes

  1. Recruitment Rate

    Time frame: 24 weeks

    The Recruitment Rate will be assessed by the number of eligible patients approached vs the number of eligible patients consent for the study, providing a number of non-participations. This will be gathered as an aspect of feasibility.

  2. Retention Rate

    Time frame: 24 weeks

    Retention rate will be examined via the number of those who consent to the study compared to the number of those who complete the study.

  3. Secondary outcome data completion rate

    Time frame: 24 weeks

    Assessed by the total number of missing data from the total list of secondary outcomes

  4. Rate of Intervention Completion

    Time frame: 12 weeks

    The percentage of exercises prescribed to the participants compared to the number of those completed.

  5. Incidence of adverse effects and injuries related to the intervention

    Time frame: Week 1 to week 12

    Assessed by the number and rate of participant recorded adverse effects and injuries related to the intervention

  6. Incidence of adverse events not related to the intervention

    Time frame: Week 1 to week 52

    The number of adverse events exhibited by the participants will be recorded with an associated grade (where relevant). A example list of adverse events are given below:

    • Constipation
    • Nausea
    • Vomiting
    • Diarrhoea
    • Skin Rash

Secondary outcomes

  1. Free-living daily activity

    Time frame: Baseline, 24 weeks

    Accelerometer; the activpal4 micro units (activpal4; https://www.palt.com/pals/)

  2. Australian Karnofsky Performance Scale (AKPS)

    Time frame: baseline, 12 and 24 weeks

    Single score from 10 to 100 (a higher score indicates better performance status).

  3. Rockwood Frailty Index, a 7-point Clinical Frailty Scale

    Time frame: baseline, 12 and 24 weeks

    1 = very fit, and 7= severely frail.

  4. Short Physical Performance Battery (SPBB)

    Time frame: baseline, 12 and 24 weeks

    Combines standing balance, 4 metre gait speed, and timed sit-to-stands to assess lower extremity function in older people

  5. Grip strength

    Time frame: baseline, 12 and 24 weeks

    Maximum force/tension (kg) in the forearm muscles using a handheld dynamometer.

  6. Bioelectrical impedance

    Time frame: baseline, 12 and 24 weeks

    Tanita body composition monitor and weight scale, a simple, non-invasive technique for measuring body composition in people with cancer

  7. Weight (kg)

    Time frame: baseline, 12 and 24 weeks

    Tanita body composition monitor and weight scale

  8. Patient-Generated Subjective Global Assessment (PG-SGA)

    Time frame: baseline and after 6, 12, and 24 weeks

    Assessment of nutritional status for people with cancer (scores from 0 - ≥9; 2-3 indicating need for basic nutrition intervention, 4-8 requiring dietetic intervention, and scores ≥9 indicating critical need for symptom management and nutritional intervention).

  9. Community Healthy Activities Model Program for Seniors (CHAMPS)

    Time frame: baseline and after 6, 12, and 24 weeks

    Self-report total physical activity questionnaire designed to estimate weekly frequency of participation and energy expenditure in physical activities.

  10. Integrated Patient Outcome Scale (IPOS)

    Time frame: baseline and after 6, 12, and 24 weeks

    measure of symptom burden with 20 items: one free-text question about main problems and concerns, 17 items on physical, psychological, spiritual problems, communication needs including with family, and practical support, scored on a 5-point Likert-type scale from 0 (best) to 4 (worst)

  11. Client Service Receipt Inventory

    Time frame: baseline and after 6, 12, and 24 weeks

    Validated questionnaire designed to collect information on service utilisation, income, accommodation and other cost-related variables

  12. EuroQol-5 Dimensions-5 Levels

    Time frame: baseline and after 6, 12, and 24 weeks

    The EQ-5D-5L is a generic health-related quality-of-life instrument with a descriptive system that comprises five dimensions (1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, and 5) anxiety/depression), each of which has five levels of severity (given in statement form). Participants select a statement under each of the five dimensions which best suits their current state. In addition, the respiratory bolt on dimension for the EQ-5D-5L. For each dimension, lower scores indicate fewer problems in that domain (e.g. a score of 1 in mobility means no issues with mobility).

  13. EuroQol-Visual Analogue Scale

    Time frame: baseline and after 6, 12, and 24 weeks

    The EQ-VAS is a self-report measure of overall health using a vertical visual analogue scale, ranging from 0 labelled as "worst possible" to 100 labelled as "best possible" health. Participants are then asked to write this number in a dedicated box.

  14. Days alive and out of hospital

    Time frame: baseline, and after 6, 12, and 24 weeks

    Hospital admission (number of days) since starting the programme

  15. Treatment completion rate

    Time frame: baseline, and after 6, 12, and 24 weeks

    Dose of cancer therapy received (percentage of dose received/dose prescribed) Treatment delay (days delayed)

  16. Infection rate

    Time frame: baseline, and after 6, 12, and 24 weeks

    Assessed by the number of episodes requiring antibiotics (oral/IV) Number of episodes requiring hospital admission (number of days)

  17. Treatment toxicity

    Time frame: baseline, and after 6, 12, and 24 weeks

    Cancer treatment-related toxicity (CTCAE v 5)

  18. Height

    Time frame: baseline, 12 and 24 weeks

    measured in cm with a Seneca Stadiometer

Sponsors and collaborators

Lead sponsor

University of Hull

Other

Registry information

Official study title

Cancer Behavioural Nutrition and Exercise Feasibility Trial - Phase II Randomised Controlled Trial Among Older Adults With Lung Cancer

Acronym: CanBenefitII

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2022
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.