PREHAB - Improving Condition Before Surgery

Cancer, Rectum Clinical Trial

Official title:

PREHABILITATION During Neoadjuvant Therapy in Patients With Cancer of the Upper Digestive Tract and Rectum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646043
• Other study ID #: 08/RVO-FNOs/2022
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: University Hospital Ostrava
• Contact: Jirí Hyncica
• Phone: 0042059737
• Email: jiri.hyncica[@]fno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The pilot research project is focused on the feasibility of a prehabilitation program for two groups of diagnoses (esophageal and stomach cancer, rectal cancer).

Description:

With the aim of achieving downstaging, downsizing, and reducing the risk of recurrence, neoadjuvant chemotherapy, possibly chemoradiotherapy - i.e. neoadjuvant therapy is indicated in the preoperative period for patients with cancer of the upper digestive tract and rectal cancer.

Chemotherapy has a negative impact not only on the overall physical and mental condition of the patient but also on the quality of life and on the daily activities of the individual, especially in the period when the organism is facing an abnormal stress load in the sense of extensive surgical procedures.

Recently, attention and efforts to improve postoperative morbidity and mortality have increasingly focused on the preoperative period. The concept of prehabilitation, which is defined as an intervention improving functional capacity before an upcoming physiological stressor, appears as a way to contribute to this. This fact is evidenced by a number of published references.

The main aim of the study is to confirm or refute the feasibility of the prehabilitation program during neoadjuvant therapy in two diagnostic groups of patients:

• - Patients with cancer of the upper digestive tract

• - Patients with rectal cancer

The prehabilitation program will be implemented in the patient's home environment.

The study aims to answer the basic research question of whether selected patients will be able to complete a home exercise regimen during the preoperative period when they will undergo neoadjuvant therapy.

As part of the study, the program's security and feasibility will be tested.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• radically operable locally advanced cancer of the esophagus, esophagogastric junction, stomach

• radically operable locally advanced carcinoma of the rectum

• the patient is able to handle the planned surgical resection procedure

• planned preoperative neoadjuvant therapy

• age > 18 years

• the ability to complete a spiroergometric examination

• the ability to carry out a prehabilitation program consent to participate in the study confirmed by signing the informed consent

Exclusion Criteria:

• contraindications for spiroergometric examination

• limitation on the part of the locomotor system to spiroergometric examination or daily exercise (e.g. amputation, severe gonarthrosis, coxarthrosis)

• inoperability determined by the interdisciplinary team

• inability to manage the planned operational performance

• acute surgical performance

• synchronous malignant disease

• multivisceral resection

• planned non-surgical therapeutic procedure

• incomplete data

Related Conditions & MeSH terms

• Cancer, Rectum
• Digestive System Neoplasms
• Rectal Neoplasms

Intervention

Behavioral:
• Physical training
Physical training consists of endurance walking and strength training. The basis for determining the number of steps per day is the baseline value of each patient. This will increase by 10-15% every week until the surgery date. The assumption of a total load increase is 120-180% compared to the baseline.
• Muscle strength training
Muscle strength training will take place using exercises to strengthen the upper and lower limbs and to strengthen the trunk. There will be a set of 5 exercises in two difficulty variants. The study subjects will perform this set 7 days a week, and will repeat the assembly a total of two times. The total time of strength training is 10 min.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of enrolled patients	The number of patients who express an interest in being included in the study from all patients diagnosed and indicated for neoadjuvant therapy in the monitored period. the reasons for refusal to enroll in the study will be monitored.	3 months
Primary	Number of patients completing the program	The number of patients who complete the prehabilitation program by the time of surgery.	3 months
Primary	Individual patient compliance	Number of days when the patient wore the smart bracelet and performed or attempted to perform the exercise program out of the total number of days in the monitored period	3 months
Secondary	Changes in spirometry examination results	Changes in spirometry examination will be assessed, comparing the baseline values with the values after training (maximum tidal volume (ml/1kg of weight/1 min), anaerobic threshold (beats/min).	3 months
Secondary	Changes in the quality of life	Changes in the quality of life will be monitored using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). This questionnaire is designed to measure cancer patients' physical, psychological and social functions.	3 months
Secondary	Parameters monitored by the oncologist	Number of patients with chemotherapy dose reduction or premature termination of chemotherapy, number of patients with complete chemotherapy, number of patients hospitalized due to chemotherapy toxicity	3 months
Secondary	Exercise program - number of steps/day	The number of steps taken by the study subjects in a day will be counted.	3 months
Secondary	Exercise program - pressing force on the dynamometer	The pressing force on the dynamometer (in kg) will be assessed at the beginning and at the end of the program.	3 months
Secondary	Exercise program - InBody examination	The InBody examination (analysis of body composition in %) will be performed at the beginning and at the end of the program.	3 months
Secondary	Exercise program - Body Mass Index	The value of Body Mass Index will be recorded at the beginning and at the end of the program will be assessed (in kg/m2), changes will be assessed.	3 months
Secondary	Exercise program - perceived exertion	The perceived exertion will be assessed using the Borg Rating of Perceived Exertion Scale (RPE). RPE is based on the physical sensations a person experiences during physical activity, including increased heart rate, increased respiration or breathing rate, increased sweating, and muscle fatigue. The rating is from 6 to 20.	3 months
Secondary	Parameters monitored by the anesthesiologist - ASA value	ASA value - the ASA physical status classification system is a system for assessing the fitness of patients before surgery. It is a five-category physical status classification defined by the American Society of Anesthesiologists.	3 months
Secondary	Parameters monitored by the anesthesiologist - morbidity assessment	Morbidity assessment among the study population will be performed, using assessment of incidence and prevalence.	3 months
Secondary	Parameters monitored by the anesthesiologist - preoperative analgesia	The use of preoperative analgesia will be recorded and assessed.	3 months
Secondary	Parameters monitored by the anesthesiologist - postoperative opioid analgesia	The use of postoperative opioid analgesia will be recorded and assessed.	3 months
Secondary	Parameters monitored by the anesthesiologist - pain assessment	The Numeric Pain Rating Scale will be used to assess pain. The Numeric Pain Rating Scale is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.	3 months
Secondary	Laboratory examinations - complete blood count	Complete blood count will be analyzed (g/L).	3 months
Secondary	Laboratory examinations - CRP values	C-Reactive Protein (CRP) will be assessed (in mg/L). C-reactive protein (CRP) is an acute phase protein that is produced in the liver. The levels increase rapidly in response to acute inflammation.	3 months
Secondary	Laboratory examinations - procalcitonin level	Procalcitonin levels will be analyzed (ng/L). This marker indicates the presence of infection.	3 months
Secondary	Laboratory examinations - nutritional parameters	Nutritional parameters - the levels of total protein, albumin and prealbumin will be analyzed (mg/dL).	3 months
Secondary	Laboratory examinations - coagulation factors (aPTTp	Coagulation factors - Activated Partial Thromboplastin Time (APTT) will be measured (in seconds).	3 months
Secondary	Laboratory examinations - coagulation factors (fibrinogen)	Coagulation factors - fibrinogen levels will be assessed (mg/dL). Higher and lower levels point to blood clotting disorders.	3 months