Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment

NCT05306652 | Recruiting

• 1 other identifier: EXcellenT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional, non-pharmacologic, randomized controlled study evaluating the impact on quality of life of a personalized exercise program in oncogene addicted lung cancer patients undergoing active treatment. Patients will be randomized 1:1 in two arms: arm A (interventional) and arm B (control). The program of physical activity will be established after a test done at the local clinical center and based on easy exercises already studied in other diseases (e.g. coronary syndrome or organ transplant). A smartphone application will allow patients to register their daily physical activity and to easily recover data on strength and endurance. Patients in Arm A will have a home-based physical activity prescription and will be supervised at weeks: 4, 6, 8, 10, 12 by the oncologist and an exercise expert of the local sport center through three exercises (body composition test, endurance test and strength test) and questionnaires. Home-based activity will be monitored daily though a specific application (provided by Technogym). Patients in Arm B will receive an exercise counselling without a subsequent supervision. The three tests and questionnaires will be repeated once a month for three months at the local sport center and oncology center. Counselling will include general information on exercise. Patients will undergo blood sampling at baseline, week 4 and week 12 in order to evaluate changes in their immunological state (lymphocyte populations and cytokines).

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC; Oncogene addiction; physical activity; personalized

Outcome Measures

Primary Outcomes (3)

• Impact of personalized prescription of physical exercises on quality of life assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)

  To evaluate the impact of a personalized prescription of physical exercises monitored through a special smartphone application on quality of life assessed with the Italian version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)

  12 weeks

• Impact of personalized prescription of physical exercises on quality of life assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for lung cancer (QLQ-LC29)

  To evaluate the impact of a personalized prescription of physical exercises monitored through a special smartphone application on quality of life assessed with the Italian version of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire for lung cancer (QLQ-LC29)

  12 weeks

• Impact of personalized prescription of physical exercises on quality of life assessed by the Beck Depression Inventory II (BDI-II)

  To evaluate the impact of a personalized prescription of physical exercises monitored through a special smartphone application on quality of life assessed with the Italian version of Beck Depression Inventory II (BDI-II)

  12 weeks

Secondary Outcomes (7)

• Adherence to prescription

  12 weeks

• change of functional capacity

  12 weeks

• change of muscle strength

  12 weeks

• tolerance to treatment

  12 weeks

• Overall survival (OS)

  24 months

Study Arms (2)

A - Home based supervised physical exercise

EXPERIMENTAL

patients will have a home-based physical activity prescription

Other: Supervised physical activity

B- Unsupervised physical exercise

ACTIVE COMPARATOR

patients will receive a physical activity counselling, without a real prescription and supervision

Other: Unsupervised physical activity

Interventions

Supervised physical activity OTHER

patients will have a home-based physical activity prescription, defined on the functional endurance and strength tests and they will be supervised for 3 months. Once monthly they will be examined by the oncologist (visit and questionnaires) and at weeks 4, 6, 8, 10 and 12 at the sport medicine center where the three tests will be repeated. Home-based activity will be monitored daily through a specific application. Endurance improvement is defined as an increase in walking speed; strength improvement is defined as an increase of the number of repetitions

A - Home based supervised physical exercise

Unsupervised physical activity OTHER

patients will receive a physical activity counselling, without a real prescription and supervision, and the three test will be repeated once a month for three months at the local sport medicine center and at the oncology center (visit and questionnaires). Counselling will include general informations on physical exercise

B- Unsupervised physical exercise

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Willingness to provide written informed consent.
• Life expectancy \>12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Body massa index \> 18.
• Oncogene-addicted (EGFR, ALK, ROS1, RET, BRAF) stage IV or III b not suitable for local treatment receiving first- or second-line systemic treatment (palliative radiotherapy and prior chemotherapy allowed). Patients undergoing treatment in clinical trials are excluded.

You may not qualify if:

• Inability to walk.
• Immobility for more than 3 days before study enrollment.
• Previously untreated (non-irradiated or non-resected) symptomatic brain metastases.
• Severe cardiac impairment (e.g. cardiac insufficiency New York Heart Association (NYHA) \> III, myocardial infarction within the last three months, severe cardiac arrhythmias, high grade aortic stenosis).
• Severe respiratory failure.
• Uncontrolled pain.
• Bone metastasis inducing increased risk of pathological fractures.

Sponsors & Collaborators

• AUSL Romagna Rimini: lead
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator

Study Sites (1)

S.Maria delle Croci Hospital, Oncology Unit

Ravenna, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Oncogene Addiction; Motor Activity

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Chiara Bennati

  AUSL Romagna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Bennati, MD

CONTACT

+39 0544 285778; chiara.bennati@auslromagna.it

Michela Spreafico

CONTACT

michela.spreafico@irst.emr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: April 1, 2022
• Study Start: April 4, 2022
• Primary Completion: June 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)