Pulmonary Resection And Intensive Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-06-30

Brief Summary

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Lung cancer is the leading cause of cancer death in males, and is increasing in females. Up to 73% of affected patients present with Chronic Obstructive Pulmonary Disease (COPD). Most lung cancer patients have an average survival of about 8 months from diagnosis. Lobectomy for initial stages has demonstrated higher survival rates, but only 15% to 25% are surgical candidates; unfortunately, cardiopulmonary impairment mainly due to coexisting COPD reduces this number and patients undergo medical treatment or marginal lung resection, with minor functional impact but possible ineffective control of disease.

Furthermore, COPD is associated with increased postoperative morbidity and mortality, longer in-hospital stay, need for additional treatments, and a rise in sanitary costs.

The investigators planned a randomised trial on surgical candidates to assess the effect of comprehensive pulmonary rehabilitation on functional and surgical outcomes, functioning, and Quality of Life (QoL).

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Detailed Description

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Preoperative pulmonary rehabilitation ameliorates functional parameters responsible for inoperability in COPD patients; candidates for surgery could benefit from this functional improvement in terms of wider possible lung resection and lower incidence of postoperative complication.

Likewise, postoperative respiratory rehabilitation significantly improves respiratory function and exercise capacity in treated patients but the effect on long-term functioning and QoL is not known.

Current studies present small-sized samples and short follow up. The impact of comprehensive rehabilitation on overall functioning, depression, pain, and QoL has only been reported for COPD patients. Moreover, the rate of anatomical resection and postoperative morbidity in compromised COPD patients treated with intensive rehabilitation has never before been reported in randomised trials.

The investigators hypothesise that: comprehensive rehabilitation intervention in lung cancer patients eligible for surgical treatment may reduce pain, comorbidity (pneumonia and other pulmonary complications requiring further treatments), depression, and deconditioning and improve QoL 1 to 6 month after surgery; active lifestyle and regular follow up may reduce long-term quality of life decline; early pulmonary rehabilitation can improve lung function tests making proper surgical treatment with curative intent possible in patients affected by COPD otherwise treated medically or by marginal operations.

Investigators have planned a randomised trial with 2 parallel arms: all patients with resectable (T1-2 N0-1) diagnosed or suspected lung cancer will be enrolled in the study at pre-operative interview with thoracic surgery consultant and then randomised by the physician data manager (T0). The Intervention Group (IG) will receive an overall rehabilitation treatment based on 10 sessions of pre-operative outpatient PR, early inpatient post-operative PR, and long-term exercise beginning 1 month after surgery and lasting for 15 sessions. Control Group (CG) will receive Standard Care (SC) based upon physiatrist counselling the day before surgery and early inpatient post-operative PR. Both groups will receive re-evaluation and, if necessary, optimization of COPD therapy before entering the study; final follow up will be at 6 months after surgery in both groups (T3), intermediate evaluations are planned immediately before surgery (T1) and 1 month after surgical treatment (T2).

The 6 minutes walk test (6MWT) proved to correlate with functional status of patients with respiratory impairments; measurement of the impact of Pulmonary Rehabilitation (PR) on 6MWT is the primary outcome of our study. Investigators expect that this kind of treatment will improve exercise tolerance expressed by the 6MWT, assessed at T0, T1, T2 and T3 in IG. Values of 6MWT in CG will be assessed at T0 and T3 (T1 only if changes in therapy have occurred).

It has been demonstrated that PR and educational therapy optimize respiratory function in COPD patients. Investigators will asses the changes in pulmonary function with Lung Function Tests (LFT): complete spirometry (static and dynamic volumes and Diffusing Capacity of Carbon Oxide) will be performed at T0, T1 e T3 in IC. The CG will be evaluated at T0 and T3 (T1 only if changes in therapy have occurred).

COPD patients eligible for lung cancer surgery often undergo sub-lobar resection to preserve respiratory function; PR could reduce lung impairment and increase the rate of lobectomies in this subset of patients. By optimizing lung function, investigators expect a reduction in post-operative complications and length of hospital stay. This will be evaluated 1 month after surgery (T2).

The therapeutic strategy of lung cancer is very complex; this causes both physical and psychological symptoms and significantly impairs patients' QoL. This important outcome will be assessed with Short-Form 12 questionnaire (SF12) at T0 and T3. Pain and depression will also be monitored with specific scales: the Numeric Rating Scale (NRS) for pain and the Hospital Anxiety and Depression Scale (HADS) to measure depression. Pain evaluations will be planned at T0, T2 and T3, depression at T0, T1 and T3.

Since there are no published data for mean and standard deviations of 6MWT after lung surgery with or without treatment, Cohen's medium effect size (d=0.5) has been used to compute sample size (n=140).

Normality for continuous variables will be assessed by Shapiro-Wilk test to decide the statistical technique to use. Thus, Student t will be used for normal variables, while Wilcoxon-Mann-Whitney test will be used for the others.

Categorical variables (presence/absence of any complication) will be analyzed through 2x2 tables and significance assessed with Chi-squared test. Risks will be described by Odds Ratio and related Confidence Interval.

With regard to primary endpoint, IC is expected to improve 6MWT at 6 months by at least 25 metres compared to CG. We also expect an improvement in postoperative outcome (less morbidity and shorter in-hospital stay) and long-term QoL, and in pain and depression levels.

An overall 10% drop-out rate is estimated, due to factors like perioperative death or major complications and need for adjuvant treatments (which would overlap postoperative rehabilitation and deeply impact on results).

Moreover, overall randomization could produce an imbalance between the two groups in some features; in presence of significant non-homogeneity of treated versus control arm, propensity score matching analysis will be applied to reduce bias due to confounding factors.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Interventional Group

Pulmonary rehabilitation

Group Type EXPERIMENTAL

Pulmonary Rehabilitation

Intervention Type PROCEDURE

The Intervention Group (IG) will receive an overall rehabilitation treatment based on 10 sessions of pre-operative outpatient PR, early inpatient post-operative PR, and long-term exercise beginning 1 month after surgery and lasting for 15 sessions

Control Group

Standard Care

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type PROCEDURE

Control Group (CG) will receive Standard Care (SC) based upon physiatrist counselling the day before surgery and early inpatient post-operative PR.

Interventions

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Pulmonary Rehabilitation

The Intervention Group (IG) will receive an overall rehabilitation treatment based on 10 sessions of pre-operative outpatient PR, early inpatient post-operative PR, and long-term exercise beginning 1 month after surgery and lasting for 15 sessions

Intervention Type PROCEDURE

Standard care

Control Group (CG) will receive Standard Care (SC) based upon physiatrist counselling the day before surgery and early inpatient post-operative PR.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* stage 1 to 2B diagnosed or suspected NSCLC in operable patients

Exclusion Criteria

* unresectable disease, N2 disease requiring induction or postoperative chemotherapy
* patients unfit for physical exercise requested by rehabilitation and assessments

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR