Exercise Intervention During Chemotherapy in Advanced Lung Cancer Patients

NCT03334071 | Unknown DMC

• 2 other identifiers: RHM CAN 096013/YH/0354
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Trial Phase: Pilot Indication: Stage IIIB/IV NSCLC Primary Objective: To assess the feasibility and tolerability of exercise training during palliative chemotherapy. Secondary Objective: 1) To assess fitness levels in patients undergoing palliative chemotherapy, and to explore whether exercise training can prevent a reduction in fitness. 2\) To determine the baseline fitness, as assessed by cardiopulmonary exercise testing (CPET), of a cohort of patients with stage IIIb/IV non small cell lung cancer who are about to initiate treatment with chemotherapy 3) To compare patients enrolled in the EMBRACE randomized controlled trial (RCT) with those who decline. 4)To investigate any relationship between baseline fitness and outcomes including therapy related complications, response, and survival in those patients who decline exercise training or are randomized to observation. 5\) To assess the feasibility of the translation of in-hospital exercise training to home-based training during chemotherapy. 6\) To document the effects of chemotherapy on cellular energetics and mitochondrial function. Rationale: Chemotherapy has a detrimental effect on physical fitness, and this effect can be later reversed by training. The investigators wish to understand the mechanism of this detrimental effect, and investigate whether it can be prevented or attenuated by giving chemotherapy concurrently with exercise training. Trial Design: Randomised controlled study (1:1) comparing chemotherapy alone, with chemotherapy plus exercise training. A subgroup of patients will have muscle biopsies. Patients who decline randomisation will be offered enrolment into an observational arm. Sample size : 100 patients (to include 48 who will be randomised, and 52 in the observational arm).

Conditions

Non Small Cell Lung Cancer; Non Small Cell Lung Cancer Stage IIIB; Non Small Cell Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

• Number of participants completing exercise sessions as a function of the whole programme.

  Adherence to the exercise training program

  12 weeks

• Adverse events

  Common Terminology on Complications (CTC AE v4)

  12 weeks

Secondary Outcomes (12)

• Fitness levels as measured by Cardiopulmonary exercise testing (CPET)

  12 weeks

• Timed up and go test (TUG)

  12 weeks

• Grip strength

  12 weeks

• Montreal score - Prognostic survival score

  12 weeks

• Health related quality of life questionnaire

  12 weeks

Study Arms (3)

Exercise Intervention

ACTIVE COMPARATOR

Patients in the intervention arm will participate in a supervised in-hospital, exercise training program on a cycle ergometer before and during chemotherapy. At week 5-6 there will be a transition period of in-hospital to home-based exercise training (at this point we will perform the exercises that they will perform at home in the in-hospital environment to ensure that the patient understands the home-based exercise training programme) and then week 7-12 will be home-based exercise training only with telephone support.

Behavioral: Exercise

Negative Control

NO INTERVENTION

Patients in the control arm will not undergo an exercise training program.

Observational

NO INTERVENTION

Patients who do not enrol in RCT will be enrolled in the observational arm

Interventions

Exercise BEHAVIORAL

High intensity interspersed with short periods of exercise at a moderate intensity (aerobic interval training). We will also include resistance training in each session. The supervised in-hospital exercise training sessions will last \<1 hour, exercise training intensities will be individually tailored to each CPET. Exercise training will involve repeated exercise bouts of 3 minutes at a moderate exercise intensity (80%AT) followed by 2 minutes of exercise at a high intensity (50%Δ) for a predetermined amount of time. The home-based training programme will involve stair climbing (where possible) and brisk walking to achieve heart rates commensurate with those achieved during the in-hospital exercise training sessions.

Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, aged over 18 years old
• Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
• Stage IIIb/IV disease
• Patients being treated with first line gemcitabine and platinum based chemotherapy (other equivalent regimens may be considered on discussion with Judith Cave)
• Performance status 0-2 (PS 2 have to be deemed fit enough to complete all cycles of chemotherapy).

You may not qualify if:

• Unable to consent
• Under 18 years
• Unable to perform CPET
• Significant cardiac ischaemia of \> 1.5mm symptomatic and \> 2mm asymptomatic observed on the baseline ECG
• Weight of \>145kg (weight limit for cycle ergometer)
• Any other contraindication to CPET based on ACCP/ATS Guidelines and summarised in the table below.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

University Hospitals Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Exercise

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sandy Jack, PhD

  University Hospitals Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Cardiopulmonary exercise testing assessor, outcome/toxicity assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exercise intervention

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 7, 2017
• Study Start: April 4, 2014
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

GB (1)