Impact of Respiratory Rehabilitation on Quality of Life in Patients With Metastatic Non-small Cell Lung Cancer Treated With Immunotherapy and Chemotherapy in the Maintenance Phase

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

About this trial

Lung cancer is highly prevalent, with approximately 46,363 new cases in 2018, accounting for 20.6% of cancer deaths in France. At diagnosis, 70% of patients have advanced or metastatic cancer, treatable only by palliative care. Respiratory rehabilitation aims to reduce symptoms, enhance performance, increase autonomy, and improve patients\' quality of life. While effective for COPD patients and other conditions causing dyspnea, its benefits in advanced, non-operable lung cancer are less studied. Some studies have shown the feasibility and safety of respiratory rehabilitation, but few have compared its impact on non-operable lung cancer patients or assessed its effect on quality of life. The main objective of the proposed study is to evaluate the impact of a respiratory rehabilitation program on the quality of life of patients with non-small cell lung cancer (NSCLC) undergoing maintenance chemotherapy and immunotherapy, compared to a control group receiving standard care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven stage IV non-small cell lung cancer patient

First-line treatment with chemotherapy combined with immunotherapy in the maintenance phase

Adenocarcinoma patient: maintenance with Alimta combined with pembrolizumab

Squamous cell carcinoma patient: maintenance with pembrolizumab alone

Disqualifiers

Small cell lung cancer, mesothelioma, neuroendocrine lung cancer

Patients with orthopedic disorders preventing respiratory rehabilitation that, in the investigator's opinion, could interfere with respiratory rehabilitation

Unresolved toxicity from previous treatment of grade > 1 (except alopecia) that, in the investigator's opinion, could interfere with respiratory rehabilitation

Symptomatic brain metastases (corticosteroid treatment is allowed if the doses administered are stable for at least one month before inclusion)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Respiratory Rehabilitation

    Procedure/Surgery

    An initial assessment is conducted upon admission to personalize the program. This includes: Clinical examination Spirometry Maximum Inspiratory Pressure (PImax) measurement Multidimensional Dyspnea Profile questionnaire at end of TM6 Exercise Functional Testing Measurement of quadriceps strength and endurance Blood gases Educational interview and shared educational assessment London Chest Activity of Daily Living (LCADL) Tobacco and/or dietary consultation The respiratory rehabilitation program, performed twice a week, includes: Exercise training on an ergocycle and treadmill (30 minutes at ventilatory threshold for the ergocycle; 30 minutes at 60-80% walking speed for the treadmill; or dyspnea rated 4-6 on the Borg scale after endurance exercise) Quadriceps muscle strengthening Therapeutic education program Group gymnastics Smoking cessation assistance Socio-psychological and nutritional support

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Respiratory rehabilitionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Life Measurement Using EORTC QLQ-C30

The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-C30. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks

Time frame
Week 0
2

Quality of Life Measurement Using EORTC QLQ-LC13

The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-LC13. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks

Time frame
Week 0
3

Quality of Life Measurement Using EORTC QLQ-C30

The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-C30. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks

Time frame
Week 8
4

Quality of Life Measurement Using EORTC QLQ-LC13

The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-LC13. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks

Time frame
Week 8

Secondary outcomes

1

Evaluation of quality of life using multiple modalities of the QLQ-C30.

Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire.

Time frame
Week 0
2

Evaluation of quality of life using multiple modalities of the QLQ-C30.

Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire.

Time frame
Week 8
3

Evaluation of quality of life using multiple modalities of the QLQ-C30.

Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire.

Time frame
Month 6
4

Evaluation of quality of life using multiple modalities of the QLQ-C30.

Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire.

Time frame
Month 12

Other outcomes

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