Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Herbal and Botanical

Loperamide

Antidiarrheals

Guar

Patient who met inclusion criteria and consented during intervention period will be assigned as PHGG group. Surgical medical officer will obtain consent from eligible subject. After consented, subjects will be assessed weight and PG-SGA during admission. They will be given 4 scoops (40g) PHGG, which provide 160kcal, 0.24g protein, 30.4g soluble fibre, 40g carbohydrate and 0g sugar once allowed orally. Staff nurse in charged will monitor compliance of subject on the PHGG. Daily stoma output \& consistency will be recorded and daily energy protein intake will be assessed by dietitian in charged. Renal profile will be taken daily as routine procedure for patients with ileostomy.

Historical records of patients with ileostomy under conventional care from January 2016 to June 2019 (before started on PHGG) will be assessed and traced retrospectively from the medical system. Data will be recorded in data collection sheet.

Subjects will be given 4 scoops (40g) PHGG, which provide 160kcal, 0.24g protein, 30.4g soluble fibre, 40g carbohydrate and 0g sugar, once allowed orally.

PHGG

follow low fibre diet and anti-diarrhea drugs

conventional care

ChiouYi Ho

this is a cross sectional intervention study to investigate the role of partial hydrolyzed guar gum in high stoma output management among cancer patients with ileostomy. This study hypotheses there is improvement in stoma output in PHGG if compare with control. There are two groups of subjects in this study. Conventional group (CG) will include retrospective historical data (those subjects with post-operative ileostomy) from Jan 2016 to June 2019. Intervention group (PHGG) will be subjects with ileostomy which involves prospective intervention by giving partial hydrolyzed guar gum upon start orally. Data on stoma output (volume \& consistency), length of hospital stay, readmission within 30-days discharged and dietary intake will be recorded in data collection form.

The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy

consistency (bristrol stool chart; range 1-7; 1 hard while 7 watery)

readmit to ward due to complications after discharge

National Cancer Institute, Malaysia

Universiti Putra Malaysia

Principal Investigator

Wounds and Injuries

Skin and Connective Tissue Diseases

Skin Neoplasms

Skin Diseases

Anti-Infective Agents

Anti-Bacterial Agents

A negative pressure wound dressing is placed over the skin graft. Patients are started on compression therapy after surgery, unless there are contraindications, and standard oral and written postoperative immobilization and other treatment instructions are given.

A conventional antimicrobial wound dressing is placed on top of the graft. Patients are started on compression therapy after surgery, unless there are contraindications, and standard oral and written postoperative immobilization and other treatment instructions are given.

Negative-pressure therapy postoperatively on the full-thickness skin graft

Negative pressure device

Conventional dressing postoperatively on the full-thickness skin graft

Conventional care

This randomized controlled non-sponsored trial on 60 patients evaluates if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications for skin-cancer surgeries below the knee.

Annually, 12 000 skin cancers are diagnosed in Finland. This randomized controlled non-sponsored trial evaluate if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications. 60 patients over 18 years of age are included and randomly assigned to either the negative pressure-treatment group or the conventional treatment group. At the control appointment one-week postsurgery, graft take is documented as a primary outcome and any complications (necrosis, infection, hematoma/seroma) and adverse events (pain, skin reactions) as secondary outcomes. Adverse events are evaluated by a phone call 3 weeks postsurgery and based on medical records 3 months postsurgery.

Negative-pressure Wound Therapy on Full-thickness Skin Grafts of the Lower Leg

A Randomized Study on the Effect of Negative-pressure Wound Therapy on Below-the-knee Skin Cancer Graft Reconstruction Complications

Helsinki University Central Hospital

Principal investigator

Symptoms and General Pathology

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Patients who are assigned to enhanced haematology palliative care ("fast-track" group) will be seen, within 2 days of enrollment, at the out-patient clinic or in-patient setting by the haematology palliative care team that comprises a palliative medicine specialist or a haematologist with palliative care experience, a full-time palliative care nurse, and a medical social worker concentrating on haematology palliative patients.

Patients who are assigned to the conventional supportive care group will be under care of haematologists and nurse specialists in haematology After 12 weeks of conventional supportive care, patients randomized to this group will receive services from the palliative care team and assessed every two weeks same the "fast-track" group

Early and proactive multidisciplinary care

Enhanced Haematology Palliative Care ("Fast-track") Group

Conventional care and referral as indicated

Conventional Care

Harinder Singh Harry Gill, MD

Objectives:

The purpose of this study is to evaluate the impact of enhanced haematology palliative care services to the most symptomatic group of blood cancer patients, namely myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML).

Hypothesis to be tested:

To test whether early integration of dedicated palliative care will improve the quality of life, mood and caregiver burden in patients with MDS and AML.

Design and subjects:

This is a 24-month open-label randomized controlled trial. Subjects include patients with MDS and AML.

Study instruments:

Interventions will be carried out by a dedicated team comprising palliative care physicians, haematologists, palliative care nurse specialists, and social workers. Outcome measures will be determined using validated questionnaires and data collection tools.

Interventions:

In this trial, enhanced haematology palliative care integrated to conventional supportive care versus conventional supportive care alone will be compared.

Main outcome measures:

The primary outcome measures include quality of life, mood and caregiver burden. The secondary outcome measures include number of admissions to acute hospital and intensive care and overall survival.

Acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) are heterogeneous haematological malignancies associated with guarded long-term outcomes. In AML, 5-year overall survivals is approximately 40% even in young patients. Relapsed or refractory state is seen in up to 40% of patients with AML is associated with a poor outlook especially in patients in-eligible for intensive treatment. MDS is rarely curable except in young patients eligible for allogeneic haematopoietic stem transplantation (HSCT). MDS failing initial treatment have median survivals of less than 6 months. Most patients with AML and MDS are diagnosed after the age of 65, making them physically-ineligible for intensive curative treatment such as HSCT. In addition to inferior survivals, most patients with relapsed or refractory AML and MDS have profound cytopenia resulting in increased risk of infections and need for frequent blood product support. Quality of life (QOL) is affected due to significant symptom burden, treatment side-effects and repeated admission. Furthermore, an increased caregiver burden could be anticipated. Patients with blood cancers, especially those with AML and MDS experience significant physical and psychological symptoms that are comparable to or exceeding that seen in patients with solid organ cancers.

Well-designed randomized controlled trials have clearly demonstrated the benefits of integrating early palliative care concurrently with standard care in cancer patients. Most of these trials demonstrated improved QOL and mood as well as reduction in the utilization of healthcare services. It is now recommended that in-patients and out-patients with advances malignancies should receive dedicated palliative care services early during the course of the disease. Caregivers may also be referred for palliative services to reduce caregiver burden.

Despite the need for specific palliative care services, growing literature suggests that patients with blood cancer are less likely to receive palliative care services early. We have also shown that most patients with AML receive palliative care late and spend most the end-of-life periods in acute hospitals. In addition, there is a lack of studies examining the impact of early dedicated multidisciplinary palliative care services on blood cancer patients' QOL, mood and caregiver burden.

In this study, investigators designed an open-label randomized controlled-study comparing early enhanced palliative care serviced versus usual care in patients with myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML).

Enhanced Palliative Care in MDS and AML

Impact of Enhanced Haematology Palliative Care Services in Patients With Myelodysplastic Syndrome and Acute Myeloid Leukaemia

Individual participant data will not be shared.

It is a 17-item patient-rated measure of QOL for patients receiving palliative care.This questionnaire was translated and validated in Hong Kong. The questionnaire consists of five domains: physical well-being (five items), psychological well-being (six items), existential well-being (four items), support (two items), and sexual function (one item). In addition, there is a single item to rate their perceived quality of life. The response categories are based on a numerical scale from 0-10 with verbal anchors at the end of the scale. For the final statistical analysis, all scores are transposed on a 0-10 scale, with 0 representing the least and 10 indicating the most desirable situation. The mean total QOL score is the average of all the 5 domain scores, with 0 representing the worst situation. The overall validation results of the MQOL-HK were acceptable. Cronbach's α for the MQOL-HK subscale ranged from 0.68 to 0.85.

Levels of anxiety and depression were self-rated by HADS, which has been found to perform well as a test for such symptoms in the general population, in cancer patients and in primary care patients. Subjects decide on how each item applies to them on a scale ranging from no feelings of anxiety or depression (0) to severe feelings of anxiety or depression (3), with scores ranging from 0 to 21 on each subscale. A subscale score of 8 to 10 indicates a possible case of anxiety or depression, whereas a subscale score of 11 or higher indicates a definite case of anxiety or depression. Severe depression or anxiety disorders are suspected for subjects scoring 15 or higher.24 The Cantonese-Chinese version of the HADS25 has been found to have good internal consistency (Cronbach's α=0.77), reasonable sensitivity (0.79) and specificity (0.80), as well as positive (0.77) and negative predictive values (0.82).

The ZBI is a widely used 22-item assessment tool for measuring the caregiver's perceived burden in providing family care. The questionnaire was translated, and modified according to Hong Kong cultural standards.

The ZBI scale was developed to measure burden among family caregivers of persons with dementia; however, it has been used in other populations and was selected for this study because of the high reliability and validity of the Chinese version, indicated by a Cronbach's alpha of 0.99 and a correlation coefficient of 0.81. The correlation between ZBI and general Health Questionnaire was 0.59 (p\<0.001), and the correlation between Caregiver Activity Survey was 0.057 (p\<0.001), suggesting high conceptual validity.

The items were scored on a five-point scale ranging from 0 (never) to 4 (always). Scores were calculated by summing up the total chosen statement which ranges from 0 to 88, that higher scores implying greater perceived caregiver burden.

Time (in weeks) from the data of recruitment to death or latest follow-up

The University of Hong Kong

Clinical Assistant Professor

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Fast track Care (Enhanced recovery after)pancreatico-duodenectomy

Conventional Care pancreatico-duodenectomy.

Enhanced recovery after pancreatico-duodenectomy, with early oral intake, mobilization \& discharge

Fast track Care pancreatico-duodenectomy.

Yasser A Debakey, Lecturer

Ahmed M Mahmoud, Professor

Few decades back pancreatico-duodenectomy (PD) was associated with a very high morbidity and mortality. With recent advancements in surgical and anesthetic techniques and improvement in peri-operative care, PD has evolved into a procedure with acceptable morbidity and mortality. Today PD is associated with a mortality of less than 5%, in high volume tertiary care centers. The multimodal concept of fast-track surgery was first introduced in colonic surgery. Several studies have demonstrated the effectiveness of this program in colonic resection. Recently, fast-track surgery has been attempted in pancreatic surgery with encouraging results, but such data are sparse. The core aims of ERAS protocols are to safely hasten postoperative recovery and ease the stress response.

Specifically, in the context of pancreatico-duodenectomy, such interventions have been shown to be safe with no increase in mortality or unplanned readmissions, delayed gastric emptying (DGE), or pancreatic fistula . Purported benefits include reduced admission related costs, incidence of DGE, overall morbidity and length of stay.

The aim of this study was to evaluate the feasibility of implementing fast track rehabilitation protocol following pancreaticoduodenectomy and to see if it is associated with improved recovery, reduced morbidity and reduced length of hospital stay.

Study population: This is a prospective study that will be conducted on all patients of both sexes and definite age groups attending the National Cancer Institute, Cairo University and candidate for pancreatico-duodenectomy Sampling: all cases fulfilling the inclusion criteria will be included in the study.

Patients will be classified into two groups:

* Group A: Fast track Care pancreatico-duodenectomy.
* Group B: Conventional Care pancreatico-duodenectomy. Baseline demographics, body mass index (BMI), perioperative parameters, postoperative course, postoperative complications and 30-days operative mortality will be analyzed.

Inclusion criteria:

* Age ≤ 75 years
* ASA 1 or 2
* BMI \< 35 The underlying pathology or use of neoadjuvant chemotherapy did not preclude inclusion into the study

Exclusion criteria:

* pancreatico-duodenectomy with vascular reconstruction.
* Unenthusiastic patients.

Type of study: randomized controlled trial The assignment of patients to either group will be done by a random computer-assissted allocation. The allocation will be done by the use of opaque envelopes with assignments.

It's an open-labeled study i.e. patients, investigators (surgeons, researchers) and data collectors will know which procedure will be done to which patients.

Discharge criteria for goup A include; uncomplicated procedure, afebrile patient without tachycardia, tolerance of oral feeding, adequate control of pain with oral analgesia, patient ambulating independently, adequate support at home.

Follow up: will be completed within one month (immediate post-operative outcome).

Less Than 100 Hours Hospital Stay After Pancreatico-duodenectomy, RCT

Feasibility will be measured by recording post operative complications according to Clavien- Dindo classification

National Cancer Institute, Egypt

Acute Disease

Neoplasms by Histologic Type

Disease Attributes

Antineoplastic Agents

Analgesics

Antirheumatic Agents

Micronutrients

Etoposide

Cytarabine

Venetoclax

Mitoxantrone

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Carboplatin

Doxorubicin

Liposomal doxorubicin

Azacitidine

Decitabine

Topotecan

Daunorubicin

Etoposide phosphate

Thioguanine

Asparaginase

Idarubicin

Midostaurin

Sorafenib

Ivosidenib

Clofarabine

Cladribine

Iodine

Cadexomer iodine

Gemtuzumab

Iomab-B in conjunction with a Reduced Intensity Conditioning (RIC) regimen containing Fludarabine and low-dose Total Body Irradiation (TBI) prior to allogeneic HCT

Defined as Investigator's choice of salvage chemotherapy with any combination of the following agents: Azacitidine (not allowed as a single agent), Carboplatin, Cladribine, Clofarabine, Cyclophosphamide, Cytarabine, Daunorubicin, Decitabine (not allowed as a single agent with the exception of patients with documented TP53 mutations who have not previously received 10-day regimens of single agent decitabine), Doxorubicin, Enasidenib, Etoposide, Fludarabine, Gemtuzumab ozogamicin, Idarubicin, Ivosidenib (for subjects with IDH1 mutation), L-Asparaginase, Midostaurin (for FLT3 mutant or FLT3-ITD subjects only, not allowed as single agent), Mitoxantrone, Sorafenib (for FLT3 mutant or FLT3-ITD subjects only, not allowed as single agent), Thioguanine, Topotecan, Venetoclax (in combination with a hypomethylating agent). Chemotherapy agents not listed above may be administered after providing clinical justification and receiving medical monitor approval prior to initiation of treatment.

Iomab-B

Avinash Desai, MD

The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care in patients with Active, Relapsed or Refractory Acute Myeloid Leukemia (AML).

SIERRA is a pivotal Phase 3 randomized controlled study of Iomab-B in Relapsed or Refractory AML patients. The SIERRA trial has a primary endpoint of durable Complete Remission (dCR) at six months and a secondary endpoint of overall survival following randomization to Iomab-B, as well as Event-Free Survival. Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially safer and more efficacious manner than intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning.

Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia

A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplant Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia (AML)

Defined as CR or CRp lasting 180 days or more from time of initial CR or CRp is documented with evidence of subsequent relapse

Duration of time from randomization to the date of induction treatment failure (ITF), relapse or death

Actinium Pharmaceuticals

Postoperative Complications

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Neostigmine

1. Preoperative preparation: shorten the fasting time, take a small amount of sugar water two hours before the surgery, and reduce excessive bowel preparation.
2. Intraoperative care: multi-model analgesia (mainly epidural analgesia), sleep depth monitoring, warm air blanket to avoid hypothermia.
3. Postoperative care: focus on pain relief methods (such as oral analgesics, patient-controlled epidural analgesia), early postoperative feeding (try drinking water on the first day after surgery, liquid diet on the second day, and soft diet on the third day), early removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters, and medication to prevent postoperative nausea and vomiting.

1. Preoperative preparation: overnight fasting preparation, bowel preparation.
2. Intraoperative care: traditional pain care (intravenous analgesics), sleep depth monitoring, warm air blanket, central venous pressure and body water monitoring indicators, traditional muscle tension relaxation treatment and the use of health insurance antagonist drugs (Neostigmine).
3. Postoperative care: patient-controlled intravenous drip for postoperative pain relief, oral feeing (rice porridge) on the postoperative day 5, and according to the progression of patient condition, step by step to removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters.

ERAS

The investigators aimed to clarify the clinical relevance of the ERAS protocol by evaluating the perioperative course in patients undergoing laparoscopic gastric cancer surgery.

Gastric cancer is 7th common malignant disease in Taiwan, accounting for 3000 new cases per year. The main treatment of gastric cancer is radical gastrectomy and lymph nodes dissection, which is associated with 13.0\~46 % of surgical morbidities. To minimize the surgical morbidities and enhance patients' recovery, perioperative management is mandatory. Enhanced Recovery After Surgery (ERAS) is a multimodal, multidisciplinary approach to the care of the surgical patient. ERAS process implementation involves a team consisting of surgeons, anesthetists, an ERAS coordinator, and staff from units that care for the surgical patient. The main elements of ERAS include carbohydrate loading before surgery, minimally invasive approaches, balanced management of intravenous fluids, multimodal pain management, early mobilization, and early oral feeding, etc. Some prospective studies have shown its effectiveness in reduce surgical morbidity and hospital stay in colorectal surgery. In Taiwan, there was only limited report to study the use of ERAS in gastric cancer surgery. The investigators would like to integrate these perioperative interventions into the ERAS program, and test its effectiveness in gastric cancer patients undergoing radical gastrectomy at NTUH.

The Effect of Enhanced Recovery After Surgery (ERAS) in Gastric Cancer Surgery

when the patient is readmitted to the hospital

Total medical expenses incurred during the admission period.

The complication rates means if there are any complications occur.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy	NCT04678349	Rectal Cancer	PHGG conventional ca...	18 Years -	Universiti Putra Malaysia
The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy	NCT04678349	Rectal Cancer	PHGG conventional ca...	18 Years -	Universiti Putra Malaysia
Negative-pressure Wound Therapy on Full-thickness Skin Grafts of the Lower Leg	NCT05451680	Skin Tumor	Negative pressu... Conventional ca...	18 Years - 110 Years	Helsinki University Central Hospital
Enhanced Palliative Care in MDS and AML	NCT04226768	Myelodysplastic...	Enhanced Haemat... Conventional Ca...	-	The University of Hong Kong
Less Than 100 Hours Hospital Stay After Pancreatico-duodenectomy, RCT	NCT05192044	Pancreas Cancer	Fast track Care... Conventional Ca...	20 Years - 75 Years	National Cancer Institute, Egypt
Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia	NCT02665065	Acute Myeloid L... Leukemia, Acute... Myeloid Leukemi... Leukemia, Myelo... Acute Myelogeno... Leukemia, Acute... Myelogenous Leu... AML Bone Marrow Tra...	Iomab-B Conventional Ca... HCT	55 Years -	Actinium Pharmaceuticals
The Effect of Enhanced Recovery After Surgery (ERAS) in Gastric Cancer Surgery	NCT06209983	Anesthesiology General Surgery	ERAS Conventional ca...	20 Years - 80 Years	National Taiwan University Hospital
Less Than 100 Hours Hospital Stay After Pancreatico-duodenectomy, RCT	NCT05192044	Pancreas Cancer	Fast track Care... Conventional Ca...	20 Years - 75 Years	National Cancer Institute, Egypt
The Effect of Enhanced Recovery After Surgery (ERAS) in Gastric Cancer Surgery	NCT06209983	Anesthesiology General Surgery	ERAS Conventional ca...	20 Years - 80 Years	National Taiwan University Hospital

Spots Global Cancer Trial Database for conventional care