Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Colonic Neoplasms

Rectal Neoplasms

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Liver Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Stomach Cancer

The individualized aerobic training program will be developed according to Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks.

Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed as follows:

Week 1: heart rate target: 50% of maximum heart rate Week 2: heart rate target: 60% of maximum heart rate Week 3: heart rate target: 70% of maximum heart rate Week 4: heart rate target: 60% of maximum heart rate The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist.

Individualized aerobic training program developed by physical therapist using Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks. Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed between 50 to 70% of the maximum heart rate and will be carried on a treadmill or in a stationary bicycle.

Preoperative exercise program

Oscar Guevara, MD, MSc

Kelly Chacon, FT

Maria T. Vallejo, Md

Oscar A Guevara, MD MSc

Patients with gastrointestinal cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal surgical procedures.

It has been suggested that physical training in the preoperative period could improve their condition, reducing the risk of complications. Although this topic has been investigated, it has not been established yet the best short preoperative aerobic exercise program to enhance the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical primary management, and consequently, to help patients dealing with the physiological stress involved in a surgical intervention.

Main objective:

To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients with gastrointestinal cancer scheduled for primary surgery.

Materials and methods:

This is a Phase II single arm clinical trial that will include patients between 45 and 70 years, with confirmed gastrointestinal cancer (gastric, hepatic, colon or rectal cancer), without electrocardiographic abnormalities, and scheduled for primary surgery in 4 weeks or more since recruitment

All the enrolled patients will receive a basal aerobic capacity assessment with the 6-minute walk test. Then, two physical therapist will prescribe them a supervised and individualized aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50 minutes and will increase the heart rate target weekly (from 50% to 70% of the maximum heart rate). The aerobic exercise will be carried on a treadmill or in a stationary bicycle.

The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test. The main efficacy outcome will be peak oxygen consumption (VO2 peak) and the safety outcomes will be exercise-related adverse events and the program adherence.

This protocol was approved by the Instituto Nacional de Cancerología's Ethical Board

Gastrointestinal - origin cancer is one of the most frequent causes of cancer worldwide ; the primary surgical management is the standard treatment, however, the postoperative complications rate could be up to 35% . Patients with gastrointestinal - origin cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal procedures.

It has been suggested that physical training in the preoperative period could improve their condition, reducing the risk of complications. Although this topic has been investigated, it has not been established yet the best short preoperative aerobic exercise program to enhance the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical primary management, and consequently, to help patients dealing with the physiological stress involved in a surgical intervention.

Main objective:

To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients with gastrointestinal cancer scheduled for primary surgery.

Materials and methods:

This is a Phase II single arm clinical trial that will include patients between 45 and 70 years, with confirmed gastrointestinal cancer (gastric, liver, colon or rectal cancer), scheduled for surgery in 4 weeks or more since recruitment and without electrocardiographic abnormalities.

The patients will be selected from the gastrointestinal unit surgical schedule. The eligible patients will be invited to participate and after their agreement to participate and to do the informed consent process, they will be scheduled to the basal assessment. This aerobic capacity assessment will be done with the 6-minute walk test.

After the basal measurement, two physical therapists will prescribe an individualized aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50 minutes and will be programmed as follows:

* Week 1: heart rate target: 50% of maximum heart rate
* Week 2: heart rate target: 60% of maximum heart rate
* Week 3: heart rate target: 70% of maximum heart rate
* Week 4: heart rate target: 60% of maximum heart rate

The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist.

The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test. The main efficacy outcome will be peak oxygen consumption (VO2 peak) and the safety outcomes will be exercise-related adverse events and the program adherence.

This protocol was approved by the Instituto Nacional de Cancerología's Ethical Board.

The individualized aerobic training program will be developed according to Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks

Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed as follows:

* Week 1: heart rate target: 50% of maximum heart rate
* Week 2: heart rate target: 60% of maximum heart rate
* Week 3: heart rate target: 70% of maximum heart rate
* Week 4: heart rate target: 60% of maximum heart rate

The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist.

The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test.

Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer.

Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer. A Phase II Clinical Trial

IPD will not be shared with other researchers

peak oxygen consumption measured in ml/kg/min using the American College of Sports Medicine's equation

any unexpected reaction secondary to the exercise program. This could be mild (nausea, fall, joint pain, tendinitis) or severe (syncope, fracture, myocardial infarction).

frequency of patients who will complete at least the 3 week program.

peak oxygen consumption measured in ml/kg/min using the American College of Sports

Universidad Nacional de Colombia

Instituto Nacional de Cancerologia, Columbia

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

A group receiving a multimodal prehabilitation programme consisting of three modalities:

1. MIET during neoadjuvant intravenous chemotherapy infusion
2. HITT and strength training during the last six weeks prior to surgery
3. Optimising nutritional intake throughout the total preoperative period

1. During the weekly chemotherapy infusion (week 10-20), a supervised moderate-intensity endurance training (MIET) on a cycle ergometer is performed (11x):

   * 5 min. warm-up
   * 35 min. cycling at 40-60% of (HR reserve + resting HR)
   * 5-10 min. cool-down
2. + strength training

During week 17-22 a supervised high-intensity interval training + strength training programme is performed (8x):

HITT:

* 3 min warm-up (20W)
* 14 intervals (30sec. work intervals at 60% of WRpeak alternates with 60-sec. rest intervals at 20W) --1 min. cool-down

Muscle strength:

4 exercises (leg press, chest press, abdominal crunch, lateral pulldown), 3 sets, 8-12 repetitions at 60% of 1-RM.

3) During 4 consultations with a dietician (week 9, 15, 20, 22) nutritional intake is evaluated and advice is given on energy and protein requirements. Patients are advised to use a digital food diary to record their intake for ≥3 days a week.

A multimodal prehabilitation programme

Hanneke van Dijk - Huisman, PhD

Anouk Weemaes, MSc

Hanneke Dijk - Huisman, PhD

The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy.

Rationale: Breast cancer is the most common type of cancer among women. The disease and treatment are associated with an increased risk of deterioration in physical fitness, muscle strength, nutritional status (sarcopenic obesity), mental well-being, health-related quality of life (HRQoL) and fatigue. To improve health outcomes, modifiable factors should be intervened as early as possible. The preoperative period during which patients receive neoadjuvant chemotherapy seems ideal to offer a multimodal lifestyle intervention, but is currently hardly used for this purpose. Nutritional status can be optimised through guidance from a dietician and self-monitoring of nutritional intake via a digital food diary. Additionally, offering a moderate-intensity endurance training (MIET) exercise programme during neoadjuvant intravenous chemotherapy infusion enables supervised exercise at a time when patients would otherwise be inactive. It may also improve tumour perfusion, thereby increasing the effectiveness of cytostatic uptake into the tumour and counteracting resistance to cytostatic drugs. The last six weeks prior to surgery can be used to further optimise cardiorespiratory fitness and muscle strength through a high-intensity interval training (HIIT) and strength training programme. Before the effect of a preoperative, multimodal lifestyle intervention in breast cancer patients receiving neoadjuvant chemotherapy can be investigated, its feasibility needs to be investigated first.

Objective: The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy.

Study design: A prospective, single-centre, longitudinal mixed-methods feasibility study.

Study population: Patients with breast cancer scheduled for neoadjuvant chemotherapy and surgery at the MUMC+ Comprehensive Cancer Center.

Intervention: The multimodal lifestyle intervention consists of three modalities. Patients are asked to complete 11 sessions of MIET during intravenous chemotherapy infusion, 8 sessions of HIIT and strength training in the last six weeks prior to surgery, and 4 consultations with a dietician throughout the preoperative period. The MIET training sessions consist of 45-50 minutes training programme on a cycle ergometer during the chemotherapy infusion. The physiotherapist will additionally advise patients to adhere (or build up to) the Nederlandse Norm Gezond Bewegen (NNGB) on remaining weekdays. The HIIT and strength training sessions consist of a 25 minutes training programme performed on a cycle ergometer, followed by four muscle-strengthening exercises. During the consultations with the dietician, patients' energy and protein intake are evaluated and advice is given on how to achieve the calculated energy and protein requirements. To improve patient self-management and empowerment, patients are also advised to use a free digital food diary.

Main study parameters/endpoints: The primary endpoint of the study is the feasibility of the multimodal lifestyle intervention with respect to recruitment, adherence, drop-out, safety and acceptance.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks of participating in the multimodal lifestyle intervention are considered minimal. The performance tests (Steep Ramp Test, 1-Repetition Maximum) are safe and feasible for this population. However, patients could experience some discomfort (exhaustion, muscle fatigue) due to the performance tests or exercise programs. Study related adverse events, related to exercise or nutritional changes, will be closely monitored and managed by the physiotherapist and dietician. Participation in study will take approximately 17.5 to 20 hours per patient. This time includes two consults with a physiotherapist, 8 sessions of HIIT and strength training, 4 consultations with a dietician, filling in the digital food diary and one semi-structured interview with the researcher to investigate acceptance of the multimodal lifestyle intervention and study procedures as perceived by patients. Patients are asked to complete questionnaires on fatigue and nutritional status on five different occasions.

A prospective, single-centre, longitudinal mixed-methods feasibility study will be performed to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer.

Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer

FeAsibility of a PReoperative, Multimodal Lifestyle InterventiOn in Patients With Breast Cancer ReceivIng Neoadjuvant Chemotherapy

We do not intent to make IPD available to other researchers.

RDI quantifies the total amount of chemotherapy drugs a patient receives relative to the planned or standard dose for a specific treatment regimen. It is calculated by dividing the total actual dose intensity (the total amount of drug received) by the total planned or standard dose intensity (the total intended or recommended amount of drug) \* 100. This approach considers the cumulative impact of all chemotherapy sessions and provides a more accurate reflection of the patient's overall exposure to the chemotherapy drugs over the course of treatment.

Treatment-related side-effects are monitored weekly by the physiotherapist throughout the study period though patient-report.

* Nausea
* Vomiting
* Oral mucositis (painful mouth)
* Diarrhea
* Constipation
* Fever
* Neutropenic fever
* Febrile neutropenia
* Periferal Sensoric neuropathy
* Handfoot syndrome
* Fatique
* Hair loss

Number of included patients / number of eligible patients within the study period

Sex, age, cancer stage, comorbidities (cardiovascular, musculoskeletal, pulmonary, neurological, other).

Number of attended sessions / total number of planned sessions

ExRDI = completed exercise dose intensity / prescribed exercise dose intensity.

Completed exercise dose intensity is defined as total duration (min.) performed in targeted HR zones \* total training duration (min.) performed.

Prescribed exercise dose intensity is defined as total duration (min) prescribed in targeted HR zones \* prescribed training duration.

ExRDI MIET = calculated for each participant individually, cumulative for all training sessions; and cumulative for all participants.

Reasons for not having executed a training session as intended (e.g., low saturation, high blood pressure, the intended training intensity could not be sustained, tiredness, etc.)

ExRDI = completed exercise dose intensity / prescribed exercise dose intensity.

Completed exercise dose intensity is defined as total duration (min) work intervals \* completed work rate (W) work interval.

Prescribed exercise dose intensity is defined as prescribed total duration (min) work intervals \* prescribed work rate (W) work interval.

ExRDI HIIT is calculated for each participant individually, cumulative for all training sessions; and cumulative for all participants.

ExRDI = completed exercise dose intensity / prescribed exercise dose intensity.

Completed exercise dose intensity is defined as completed training volume (weight \* sets \* repetitions)

Prescribed exercise dose intensity is defined as prescribed training volume (weight \* sets \* repetitions)

ExRDI strength training is calculated per participant per training session for each exercise and for all four exercises cumulative. And cumulative for all training sessions; and cumulative for all participants.

Number of days the food diary is filled out / total number of days agreed to complete

Number of days on which individual nutritional recommendations (energy and protein intake) were achieved / number of days on which 'Mijn Eetmeter' is filled out

Reasons for not achieving the nutritional requirement as intended

Number of participants who dropped out divided by the total number of participants

Time point in the study (week number after inclusion) during which patients drop-out

Any untoward medical occurrence or effect that:

* results in death;
* is life threatening (at the time of the event);
* requires hospitalisation or prolongation of existing inpatients' hospitalisation;
* results in persistent or significant disability or incapacity;
* is a congenital anomaly or birth defect; or
* any other important medical event that did not result in any of the outcomes listed above due to medical or surgical intervention but could have been based upon appropriate judgement by the investigator. An elective hospital admission will not be considered as a serious adverse event.

Any occurrence of the following study related adverse events during or immediately after a MIET or HITT and strength training session:

* Early termination of the training, because of the occurrence of one of the subjective or objective termination criteria (as described in section 5.1)
* extravasation (unintentional leakage of the chemotherapy agent from the vein into the surrounding tissue
* collapse
* severe muscle pain lasting \>2 days
* dizziness
* severe nausea
* excessive sweating
* palpitations or chest pain during exertion

Experiences with the multimodal lifestyle intervention as perceived by patients. Experiences are explored by the researcher through conducting a semi-structured interviews with every patient. Semi-structured, individual, in-depth interviews are conducted in Dutch . Interviews are aimed to last 30 minutes sand will be conducted in a private room at the Department of Physiotherapy of the MUMC+.

Topic guide:

* What was your experience with the multimodal lifestyle intervention in general?
* What was your experience with the Moderate-intensity endurance training (MIET) during intravenous chemotherapy infusion?
* What was your experience with the High-intensity interval training (HIIT) and strength training
* What was your experience with the nutritional counselling and use of the digital food diary 'Mijn Eetmeter'?

Suitability of the intervention and study procedures as perceived by patients Suitability is explored by the researcher through conducting a semi-structured interviews with every patient. Semi-structured, individual, in-depth interviews are conducted in Dutch . Interviews are aimed to last 30 minutes sand will be conducted in a private room at the Department of Physiotherapy of the MUMC+.

Topic guide:

* Did you consider the intervention to be suitable for patients with breast cancer receiving neoadjuvant chemotherapy?
* Did you consider the study procedures to be suitable for patients with breast cancer receiving neoadjuvant chemotherapy?

Barriers and enablers regarding participation in the study as perceived by patients.

Barriers and enablers are explored by the researcher through conducting a semi-structured interviews with every patient. Semi-structured, individual, in-depth interviews are conducted in Dutch . Interviews are aimed to last 30 minutes sand will be conducted in a private room at the Department of Physiotherapy of the MUMC+.

Topic guide:

* Which factors have positively influenced participation in the intervention?
* Which factors have negatively influenced participation in the intervention?

Fatique as determined on the Multidimensional Fatigue Index (MFI-20)

Peak Work Rate (WRpeak) (W/kg) as determined on the Modified Steep Ramp Test (SRT)

1-repetition maximum (1-RM) (kg) as determined by the Indirect RM tests on the leg press, chest press, abdominal crunch and lateral pulldown strength equipment

Nutritional status as determined by the Patient Generated Subjective Global Assessment (PG-SGA) short form. The PG-SGA short form results in a PG-SGA score between 0 and 36 with a higher score indicating a higher risk of malnutrition and a higher need to intervene regarding the nutritional status.

Scoring:

0-1 = no intervention needed at this time. Regular reassessment during treatment.

2-3 = education to patient and family by dietitian, nurse, or other healthcare provider with medication intervention as indicated by present symptoms (section 3) and laboratory tests if applicable.

4-8 = (multidisciplinary) nutritional intervention by dietitian necessary, in combination with nurse or physician as indicated by present symptoms.

≥9 = severe indication for improved symptom control and/or nutritional intervention.

Weight measured in kg on a weighing scale

Height measured in centimeters on a stadometer

Determined by self-reported nutritional intake using the 'Mijn Eetmeter' digital food diary on at least three days per week (two weekdays and 1 weekend day)

Calculated using the WHO-formula in patients with a BMI ≤ 30 kg/m2, and using the Harris \& Benedict formula in patients with a BMI \> 30 kg/m2

1.2 - 1.5 g protein/ kg body weight per day BMI \< 20 kg/m2: calculation based on weight matching a BMI of 20 kg/m2 BMI 20 - 25 kg/m2: calculation based on actual weight BMI \> 25 kg/m2: calculation based on fat free mass determined by the formula of Gallagher

Circumference of upper arm and waist (cm) measured in stance using a tape measure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer.	NCT03423056	Stomach Neoplas... Colonic Neoplas... Rectal Neoplasm... Liver Neoplasm	Preoperative ex...	45 Years - 70 Years	Instituto Nacional de Cancerologia, Columbia
Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer	NCT06266312	Breast Cancer Breast Neoplasm...	A multimodal pr...	18 Years -	Maastricht University Medical Center

Spots Global Cancer Trial Database for preoperative period