Physical activity advices adaptated to physical status of patients

Daily physical activities based on a standard guide

Physical activity advices according to a program adapted to physical status of the patient.

Adapted physical activity

Classic physical activities

Isabelle BOURDEL MARCHASSON, Pr

Adélaïde DOUSSAU, Dr

The investigators will propose to older cancer patients with good prognosis (curative care) a randomized trial of adapted physical activity during one year. To increase generalisation of the intervention the investigators intend to compare the PNNS advices (the French National Nutrition and Health Program) to a program targeted on the own capacities of each patient.

Long-term evolution of successful-treated older patients is not well-known except for survival. They seem more affected by physical than psychological problems. The combined effects of aging, cancer, and treatments on muscle function could have hindered their usual physical activity. Cancer is associated with frailty. Fried and coll have defined a frailty phenotype as a combination of 3 or more of 5 conditions: exhaustion, loss of weight, decreased muscle strength, slow gait speed and low physical activity. Frail subjects have a higher risk of physical or cognitive disability and death. An intervention able to prevent frailty is of great interest for the older cancer patient and their quality of life. An intervention consisting of phone-program in physical activity has been associated with a decrease in self-reported disability in five-year obese survivors from cancer.

Patients will be randomized in two arms (1:1 ratio). Arm 1: Physical activity advices according to a program adapted to physical status of the patient assessed using SPPB (short physical performance battery) and the IPAQ questionnaire. A monthly phone support during one year will be performed by an adapted physical activity instructor and delivery of PNNS guide for subjects older than 55 y old. Arm 2: Delivery of PNNS guide for subjects older than 55 year old: recommendation of 1/2 hour physical activity of any kind.

Each patient will be followed during 2 years: First visit (V1) will take place before treatment. The subsequent visits will take place at 3 months (V2), 6 months (V3), 1 year (V4), 18 months (V5) and 2 years (V6), in which patients will complete questionnaires (IPAQ, QLQ-C30, one day dietary intakes), have clinical examinations (weight, performance status/ ECOG) and will be tested for physical facilities (SPPB, micro-fet2). These evaluations will be completed by the MMS / Fluency tests and the covered distance during 6 minutes at V1, V3, and V4.

Physical Activity Advices to Prevent Loss of Autonomy in Cancer Treated Elderly Patients. An Intervention Randomized Study

The main outcome will be the proportion of subjects with a one-year decreased SPPB score of one point or more in 12.

IPAQ, QLQ-C30, ADL, performance status (ECOG)

University Hospital, Bordeaux

Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Frailty

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Herbal and Botanical

Anesthetics

Imidacloprid

Cola

The Combined Endoscopic Laparoscopic Surgery (CELS) is a hybrid procedure that enables large local excisions of the colon without segmental resection while under general anaesthesia. In our study, CELS refers only to endoscopic assisted laparoscopic resection.

Standard surgical resection of colonic cancer following standard oncologic principles while under general anaesthesia.

The main surgical advantage in this procedure is the ability to view the colon intra- and extraluminal simultaneously. The laparoscopic approach enables manipulation and mobilization of the colon, while the endoscopic view secures that the resection is complete and not overlapping the ileac valve or creating stenosis.

Compared to the traditional oncological colon resection, the CELS resection is a minimally invasive procedure - organ sparing procedure leading to a reduced surgical stress response.

Combined Endoscopic Laparoscopic Surgery (CELS)

In this study standard resection of the colon will be performed according to complete mesocolic excision (CME) principles.

Standard resection

Ilze Ose, MD

Ismail Gögenur, Prof.

Mads Falk Klein

Henrik Loft Jacobsen

Ilze Ose, Prof.

Ismail Gögenur

Mortality following elective colorectal cancer surgery range between 2.5-6% and increase for the elderly and frail patient regardless of T-stage. Around 80% of the patients who present with a colon cancer and is in a condition where surgery is possible will be offered resection of the tumor. A part of the colon is always removed together with the lymph nodes in order to ensure that cancer cells are not left behind. The risk of lymph node metastasis is dependent on several histopathological characteristics of the tumor. The overall risk of lymph node metastases is less than 20 % in patients with early colon cancer. This indicates that the majority of patients with early colon cancer have no benefit of additional resection besides local tumor excision. The alternative to resecting a larger part of the bowel is to make more focused surgery only resecting a small part of the bowel part through a combination of laparoscopic and endoscopic techniques. This new organ sparing approach is called Combined Endoscopic Laparoscopic Surgery (CELS). The investigators aimed to examinate the hypothesis that organ preserving approach (CELS) provides superior quality of recovery in elderly frail patients with small colon cancers when compared with standard surgery in RCT.

The "SPARCOL" Study

Organ SPARring Surgery vs. Standard Resection for Early Stage COLon Cancer in Elderly Frail Patients

Validated to measure recovery after surgery and general anesthesia, and additionally validated for use in Danish language and culture. The scale is arbitrary and ranges from 0 to 150. Higher scores means better recovery. The established minimum clinically important difference in QoR-15 is 8.0, and the SD of QoR- 15 scores after major surgery is in the order of 16.

The 30 Second Sit to Stand Test. A measurement that assesses functional lower extremity strength in older adults. Test result is the number of times the participant comes to a full standing position in 30 seconds. Higher number of stands within 30 seconds means better result.

Six minutes' walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.

EORTC C30, questionnaire, developed to assess the quality of life of cancer patients. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).

EORTC CRC questionnaire, developed to assess the quality of life of cancer patients. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).

The G-8 Score is a screening tool containing 8 questions. The total G-8 score lies between 0 and 17. A higher score indicates a better health status.

Descriptive registration of intraoperative complications;

Conversion rate (%) from laparoscopic surgery to open surgery

R0 (tumor-free margin \>1 mm) corresponds to resection for cure or complete remission. R1 to microscopic residual tumor, R2 to macroscopic residual tumor.

Assessment of histopathological risk factor defined as presence of at least one of the risk factors: Kikuchi level ≥sm2, vascular invasion, lymphatic invasion, poorly differentiated adenocarcinoma, and tumour budding BD2-3.

Time from surgery until the recurrence of disease or death

Overall survival was defined as the time elapsed from the date of surgery to the last day of follow-up or the date of death

Locoregional and/or distant recurrence after surgery defined as any histological, morphological, and clinical evidence of tumour growth during follow-up periode

Grading system used in surgery for grading adverse events (i.e. complications) which occur as a result of surgical procedures. Grade I to V, where V is death of the patient

e Comprehensive Complication Index (CCI®) reflects the gravity of this overall complication burden on the patient on a scale from 0 (no complication) to 100 (death)

Clinical metric that measures the length of time in days elapsed between a patient's hospital admittance and discharge.

Death within 90 days after surgery, as either an inpatient or outpatient

Unplanned readmissions that happen within 3 days of discharge from the index (i.e., initial) admission

Rate in percent of performed secondary surgery after primary CELS resection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Physical Activity Advices to Prevent Loss of Autonomy in Cancer Treated Elderly Patients. An Intervention Randomized Study	NCT01432067	Cancer Elderly Populat...	Adapted physica... Classic physica...	70 Years -	University Hospital, Bordeaux
The "SPARCOL" Study	NCT05734300	Colon Cancer Frailty	Combined Endosc... Standard resect...	65 Years -	Zealand University Hospital

Spots Global Cancer Trial Database for elderly population