Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Letrozole

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Definitive surgery without preoperative AI treatment

Treatment with letrozole for 4 months before definitive surgery.

letrozole (Femara)

Bent Ejlertsen, MD, PhD

The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.

Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer

Randomized Trial of Endocrine Therapy Against Locoregional Therapy First. A DBCG Trial in Postmenopausal Patients With Operable Hormone Receptor Positive Tumors Larger Than 2 cm.

The Danish Medical Research Council

Danish Cancer Society

Novartis

Danish Breast Cancer Cooperative Group

Professor, MD, PhD

Digestive System Diseases

Blood and Lymph Conditions

Behaviors and Mental Disorders

Colorectal Neoplasms

Adenocarcinoma

Postoperative Complications

Anemia

Hematologic Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Micronutrients

Hematinics

Anti-Infective Agents

Iron

Hepcidins

All recruited patients will be allocated to this treatment. 1 gram of Ferric carboxymaltose (FERINJECT) to be given at recruitment

1 gram intravenous ferric carboxymaltose (FERINJECT) will be administered to all patients within the study

Intravenous ferric carboxymaltose

Austin G Acheson, MD FRCS

20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous ferric carboxymaltose (FERINJECT).

It is hypothesized that intravenous iron supplementation is efficacious at raising haemoglobin levels and reduced blood transfusion requirements.

Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer.

At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.

This is open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.

All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.

Intravenous Iron: Measuring Response in Anemic Surgical Patients

An Open Label Study of Intravenous Iron (FERINJECT) in Colorectal Adenocarcinoma Related Anaemia to Identify Potential Biomarkers of Responsiveness to Intravenous Iron

To assess the safety and feasibility of the principle of administration of intravenous iron in a single dose, preoperative outpatient visit

To determine if the administration of intravenous iron reduces the number of expected allogenic red blood cell transfusions from recruitment to the perioperative phase

To determine if intravenous iron significantly increases hemoglobin levels in the preoperative optimization of patients

To monitor changes in hepcidin in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in Erythropoietin in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in transferrin saturation levels in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in ferritin levels in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in C Reactive Protein levels over the course of the study, and review if this can predict response to intravenous iron therapy, or is associated with changes in hepcidin

Nottingham University Hospitals NHS Trust

Mineral

Iron Supplement

A minimum of 1 dose of 1000mg of intravenous ferric carboxymaltose will be administered at least 14 days prior to the date of operation.

Ferric carboxymaltose

(Control) 200mg twice a day of oral ferrous sulphate will be administered for a minimum of a two week period

Ferrous Sulphate

Austin G Acheson, MBBS MD FRCS

116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia will be randomized to receive either oral ferrous sulphate (control) or intravenous ferric carboxymaltose (intervention).

It is hypothesized that intravenous iron supplementation is more efficacious than oral iron therapy.

Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer.

At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.

This is a multi-center, randomized, open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. Patients will be randomized to receive intravenous ferric carboxymaltose (treatment group) or oral ferrous sulphate (control). The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles, patient quality of life scores, operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.

The primary hypothesis to be tested is that intravenous iron will decrease transfusion rates. To detect a significant clinical difference in blood transfused consistent with previous published data (1 unit), 58 patients will be required in each arm of the study with 90% power (alpha 0.05).

Randomization will be performed independently to the trial team using a computer generated variable block randomization program.

All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.

IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia

An Open Label Study to Determine the Efficacy of Ferric Carboxymaltose in Preoperative Colorectal Cancer Related Anaemia, and to Develop Biomarkers to Predict Response to This Treatment Strategy

To investigate if the number of units transfused per participant, the number of participants whom receive a blood transfusion and the total number of units of blood transfused differs between the two study arms. This period monitored will begin at enrolment into the study, and cease at review in outpatient clinic 6 - 12 weeks post operatively.

Hematinic markers include ferritin, iron, transferrin, transferrin saturation, erythropoietin.

To review the use of hepcidin as a biomarker to predict response to therapy.

Iron transport proteins include DMT TFR1, Ferroportin, Ferritin. As acquired from examination of pathology tissue specimen excised.

Post-operative outcomes include morbidity, mortality, length of stay.

Quality of Life questionnaires will be used (SF-36\[short form 36\] and EQ-5D)

National Institute for Health Research, United Kingdom

Rare Diseases

Stomach Neoplasms

Colonic Neoplasms

Rectal Neoplasms

Liver Neoplasms

Stomach Diseases

Liver 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

Sarcoma

Osteosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Facility and home-based multimodal prehabilitation (aerobic exercise training, resistance exercise training, nutrition support, stress management and mindfulness training)

Multimodal Prehabilitation

* Aerobic exercise

  * Home-based, high-intensity interval training (HIIT), 2 days/week
  * Home-based, moderate-intensity continuous training (MICT), 2-3 days/week
* Resistance exercise

  * Home-based, moderate-intensity resistance training, 2-3 d/wk, all major muscle groups (working around tumour-related deficits), 8-10 exercises, 12-15 repetitions, resistance bands and body weight based
* Nutrition

  * Protein intake 1.2-1.5 g/kg body weight/day in compliance with European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines
* Stress management

  * Daily mindfulness practice, 20 min/session, guided by audio file created at Mount Sinai Hospital

Multimodal prehabilitation

Daniel R Santa Mina, PhD

The purpose of this study was to evaluate the feasibility of a multimodal prehabilitation intervention intended to optimize postoperative recovery in adolescents and young adults (AYAs) diagnosed with soft tissue and bone-based sarcomas of the upper and lower extremities (extremity sarcomas; ES).

Objectives:

This objective of this study was to investigate the feasibility of multimodal prehabilitation for adolescents and young adults (AYAs) diagnosed with soft tissue and bone-based sarcomas of the upper and lower extremities (extremity sarcomas; ES) and explore its effects on measurements of health-related quality of life, physical function, length of hospital stays, and post-operative complications. Specific aims of the study included:

* To determine the feasibility of conducting a larger phase II investigation of HIIT-based multimodal prehabilitation according to three primary criteria, including (i) recruiting \>=50% of otherwise eligible patients (OEP; i.e., patients meeting all eligibility criteria), (ii) no patient experiences a testing-related or an intervention-related serious adverse event (SAE), and (iii) patients achieve an exercise intervention adherence rate of \>=70%.
* To further determine the feasibility of conducting a larger phase II investigation of HIIT-based multimodal prehabilitation according to the secondary feasibility criteria.
* To explore the preliminary effects of prehabilitation on measures of short-term perioperative outcomes including health-related quality of life, physical function, length of hospital stays, and post-operative complications.

Methods:

A single-arm, proof-of-concept trial design was informed by the ORBIT model of behavioural treatment development. Mixed methods were employed to obtain relevant context for investigating the feasibility of multimodal prehabilitation in newly diagnosed AYAs with ES within the circumstances of the COVID-19 pandemic.

Participants underwent virtual multimodal prehabilitation before undergoing major extremity sarcoma surgery. This program encompassed personalized exercise, nutrition, and stress management support delivered by a registered kinesiologist, registered dietitian, and clinical psychologist, respectively. The interventions were designed to enhance physical and psychological resilience to stress, with the objective of improving recovery outcomes and mitigating the risk of adverse events.

Feasibility (e.g., recruitment, safety, tolerability), physical function, and patient-reported outcomes were measured at baseline (T0), immediately preoperatively (T1), and one month postoperatively (T2).

Feasibility data and field notes were collected by the research coordinators (during recruitment and postoperative follow-up) and by the study lead / research assistants during the intervention period. A postoperative interview explored experiences with prehabilitation into explore the feasibility and practical considerations of virtual prehabilitation for adolescents and young adults with extremity sarcomas.

Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas

Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas (PICaSO-ES): A Proof-of-Concept Trial

Primary exploratory outcome: European Organization for the Research and Treatment of Cancer (EORTC) QLC-C30

Postoperative complication severity and frequency defined according to the Common Terminology Criteria for Adverse Events.

Average postoperative hospitalization period

Total distance traveled during six-minute walk test

Godin Leisure-time Exercise Questionnaire

EQ-5D; All 5 items are rated on a 1 to 3 scale with higher numbers reflecting worse outcomes.

Edmonton Symptom Assessment Scale (ESAS); All 10 items are rated on a 0 to 10 scale with higher numbers reflecting worse outcomes.

Hospital Anxiety and Depression Scale (HADS); All 14 items are rated on a 0 to 3 scale with higher numbers reflecting worse outcomes.

Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F); All 13 items are rated on a 0 to 4 scale with higher numbers reflecting worse outcomes.

Medical Outcomes Study Social Support Scale (SF-20); All item scores transformed into 0 to 100 scales with higher scores reflecting better outcomes.

Experiences in Close Relationships scale (ECR); All 36 items rated on a 1 to 7 scale with higher scores reflecting worse outcomes.

Toronto Extremity Salvage Score (upper or lower)

Defined as the percent of consenting patients based on the total number of otherwise eligible patients (OEP; patients meeting all study eligibility criteria) approached

Defined as the number and frequency of testing- and intervention-related serious adverse events (SAEs) according to the Common Terminology Criteria for Adverse Events

Defined as relative dose intensity as the percent of total dose of exercise performed relative to the total planned dose prescribed and quantified according to metabolic equivalents

Defined as the average number of OEP identified each month

Defined as the percent of consenting patients who successfully complete baseline assessments based on the total number of consenting patients

Defined as the average elapsed time (in days) between diagnosis and extremity sarcoma surgery

Defined as the number and frequency of testing- and intervention-related non-serious adverse events (nSAEs) according to the Common Terminology Criteria for Adverse Events

Defined as percent completion physical testing at baseline and follow-up

Defined as the percent of all tests which are adapted for functional or safety reasons

Defined as the percent of all exercise sessions which are adapted for functional or safety reasons

Defined as the percent of patients who discontinue intervention participation prior to the planned end of the intervention period

Defined as the percent of patients who miss ≥3 consecutive sessions within the intervention period

Defined as the percent of exercise sessions requiring a dose reduction during training (i.e., intensity or duration) relative to the total number of sessions completed. Total number of exercise sessions with a reduction in intensity or a reduction in duration will be combined into the numerator when calculating the percentage of affected sessions.

Defined as the percent of exercise sessions requiring unplanned early termination

Defined as the percent of sessions which required pre-exercise modification of the target exercise intensity due to a pre-exercise screening indication (e.g., fatigue, pain)

Defined as the percent of exercise sessions completed based on the total number of sessions prescribed

Defined as the percent of psychological sessions completed based on the total number of sessions prescribed

Defined as the percent loss to follow-up (not completing follow-up assessments), individually and overall

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer	NCT00908531	Operable Breast...	letrozole (Fema...	60 Years -	Danish Breast Cancer Cooperative Group
Intravenous Iron: Measuring Response in Anemic Surgical Patients	NCT02057471	Colorectal Neop... Anemia	Intravenous fer...	18 Years -	Nottingham University Hospitals NHS Trust
IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia	NCT01701310	Anemia Colorectal Neop...	Ferric carboxym... Ferrous Sulphat...	18 Years -	Nottingham University Hospitals NHS Trust
Intravenous Iron: Measuring Response in Anemic Surgical Patients	NCT02057471	Colorectal Neop... Anemia	Intravenous fer...	18 Years -	Nottingham University Hospitals NHS Trust
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
Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas	NCT04248959	Sarcoma,Soft Ti... Osteosarcoma	Multimodal preh...	18 Years - 39 Years	University Health Network, Toronto
Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas	NCT04248959	Sarcoma,Soft Ti... Osteosarcoma	Multimodal preh...	18 Years - 39 Years	University Health Network, Toronto

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