Lung Cancer Clinical Trial
Official title:
Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery
The investigators propose a randomized controlled study in patients undergoing lung resection for cancer to compare the impact of multimodal intervention composed of exercise, nutritional supplement and psychological well-being on functional exercise capacity. One group (rehabilitation group) will receive the multimodal intervention after surgery for 8 weeks; the other will start 4 weeks before surgery and continue for 8 weeks postop (prehabilitation group). In this case, both groups will be exposed to the program, which will be available to both groups postoperatively. One of the two groups will start this program 4 weeks before surgery and continue for 8 weeks postoperatively, and the other will start once they leave the hospital and continue for 8 weeks postoperatively.
Interventions
The multidisciplinary program is composed of 3 elements: exercise, nutritional supplements
and psychological coping strategies
Exercise program
Patients will be seen by a kinesiologist for a period of 1 hour and he/she will assess
patients' mobility and capacity to undertake exercise, will prepare a personalized program
and will explain and monitor the exercise program. Patients will be instructed on how to
conduct aerobic exercise in the lab and at home, by either walking or cycling initially at
50% of the calculated heart rate reserve for 20 min three times per week, and this will be
increased in stepwise increments by 10% each week, if tolerable.
Muscular resistance training will be also carried out 3 times a week to avoid muscle
soreness. Persons will be instructed to do push-up, sit-ups, and standing strides (lunges)
until volitional fatigue increasing this number to reach 12 repetitions. The resistance
chosen for strengthening of biceps, deltoids and quadriceps will be based on what the person
can lift to reach volitional fatigue with 8 repetitions.
Psychological program
It is expected that patients undergoing surgery for cancer are anxious with some component of
depression. Since both anxiety and depression can influence the motivation to carry out
social and functional activities, psychological strategies can be put in place to help
patients to cope with the stress of surgery and disease. For this reason patients will be
seen by a trained psychologist. Patients will receive a total of 1.5 hours of psychological
intervention in the first session and more sessions if necessary.
In the first preoperative session, the first hour will address the patient's anxieties,
coping strategies, and post-operative expectations, with the goal of optimizing psychological
well-being & ways of coping with surgery. The importance of the patient's active
participation in the healing process will also be discussed. The last thirty minutes will be
devoted to teaching relaxation techniques and breathing exercises. Patients will be given a
relaxation CD to take home for practice.
Nutritional supplementation
The nutritional status of patients affected by lung cancer is directly influenced by the
presence of cancer, which impacts on all aspects of intermediary (protein, carbohydrate,
lipid, trace element, vitamin) metabolism, and by other factors such as age, adjuvant cancer
therapy and stage of the disease. The greater sensitivity of protein catabolism to
nutritional support, in particular to amino acids, could have important implications for the
nutritional management of these patients during the period of catabolic stress, with
particular emphasis on substrate utilization and energy requirement.
The patients' nutritional status and dietary intake will be assessed by the nutritionist.
Percentage of lean body mass and fat percentage will be measured. All patients will receive a
daily dietary supplement known as whey protein (Immunocal, Immunotec ©). Special precautions
will be considered if patients have specific medical conditions (e.g. diabetes).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03918538 -
A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
|
N/A | |
Recruiting |
NCT05078918 -
Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT04548830 -
Safety of Lung Cryobiopsy in People With Cancer
|
Phase 2 | |
Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
Recruiting |
NCT05898594 -
Lung Cancer Screening in High-risk Black Women
|
N/A | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03575793 -
A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
Terminated |
NCT03275688 -
NanoSpectrometer Biomarker Discovery and Confirmation Study
|
||
Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06052449 -
Assessing Social Determinants of Health to Increase Cancer Screening
|
N/A | |
Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
Recruiting |
NCT05787522 -
Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
|