Clinical trial NCT06510088: Effects of Multimodal Prehabilitation on Frail Elderly Patients Undergoing Elective Gastric Cancer Surgery
Official title: Prognostic Impact of a 3-week Multimodal Prehabilitation Program on Frail Elderly Patients Undergoing Elective Gastric Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Frail
Gastric Cancer
Prehabilitation
Lead sponsor: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 112
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Research indicates that prehabilitation is effective in optimizing physical status before surgery, although this method may be considered "aggressive" for frail elderly patients. This study aimed to evaluate whether multimodal prehabilitation consisting of preoperative physical therapy, nutritional support, and cognitive exercises decreases postoperative complications and improves functional recovery in frail elderly patients undergoing gastric cancer surgery, in comparison to usual clinical care.

Detailed description: Gastric cancer remains a significant health concern globally, especially among elderly individuals, where it poses a considerable burden due to its aggressive nature and limited therapeutic options. Population aging, a result of demographic transition, presents a critical societal challenge. According to a 2022 report by the World Health Organization (WHO), the median age for gastric cancer diagnosis is 69 years, with patients over 75 years facing heightened risks of morbidity and mortality. Although surgical resection remains the primary treatment for gastric cancer, the proportion of elderly patients undergoing surgery declines with age due to preoperative frailty. Frailty, marked by age-related declines in energy, muscle strength, weight, and activity levels, is common among elderly gastric cancer patients and correlates with poorer surgical outcomes, including higher morbidity and mortality. Therefore, interventions aimed at enhancing the functional status and resilience of frail elderly patients undergoing surgery for gastric cancer are critically important.

Numerous studies have demonstrated that prehabilitation can diminish complications, hospital readmissions, length of hospital stay (LOS), and care dependence by enhancing functional reserve. However, these studies did not differentiate between age groups and frailty status, making it difficult to interpret the relationship between the outcomes and advanced age or frailty. It is hypothesized that patients at higher risk for postoperative complications, such as frail elderly individuals, are more likely to benefit from prehabilitation. Nonetheless, conclusive evidence on multimodal rehabilitation specifically designed for this vulnerable population remains insufficient.

Prehabilitation seeks to optimize patients' preoperative risk factors during the waiting period before surgery. This preoperative phase is a critical time to modify health behaviors to reduce the stress of surgery and enhance the recovery process. Multimodal prehabilitation encompasses various interventions, including physical exercise, nutritional optimization, and psychological support, aiming to bolster physiological reserve in anticipation of the expected adverse effects of surgery and to support the postoperative recovery of functional capacity, particularly in patients with lower preoperative fitness levels. Several studies have demonstrated that prehabilitation can diminish complications, hospital readmissions, LOS, and care dependence by enhancing functional reserve. However, during their research, the patients' age group and frailty status were not differentiated, and the relationship between the results and advanced age/frailty cannot be well interpreted. It is hypothesized that patients at higher risk for postoperative complications, such as frail elderly individuals, are more likely to benefit from prehabilitation. Nonetheless, definitive evidence on multimodal rehabilitation specifically tailored to this vulnerable population is lacking.

Therefore, we implemented a randomized clinical trial to provide evidence regarding the potential advantages of multimodal prehabilitation on the outcomes of frail elderly patients undergoing elective gastric cancer surgery.

Eligibility criteria: Inclusion Criteria:

1. Patients over the age of 65;
2. Patients with a Fried Frailty Index score of 2 or higher;
3. Patients who were scheduled for surgical resection of gastric adenocarcinoma;
4. Patients whose life expectancy was estimated by the surgeon to be greater than six months -

Exclusion Criteria:

Patients were excluded from the study if they:

1. were scheduled for neoadjuvant therapy;
2. had metastatic cancer;
3. were unable to swallow or participate in exercise and fitness assessments due to pre-existing conditions (e.g., orthopedic, neuromuscular, or cardiorespiratory diseases);
4. had low compliance, defined as executing less than 70% of the weekly plan;
5. had incomplete data or were lost to follow-up. -

Primary outcomes:
measure: postoperative complications
timeFrame: 30-day after surgery
measure: 6-minute walking distance (6MWD)
timeFrame: 30-day after surgery3-month after surgery
Secondary outcomes:
measure: recovery of gastrointestinal function
timeFrame: 30 days after surgery
measure: QoL
timeFrame: 3-month after surgery
measure: physical activity
timeFrame: 3-month after surgery
measure: psychological status
timeFrame: 3-month after surgery
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: Senbin Lin
role: PRINCIPAL_INVESTIGATOR
References: