Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Participants will receive the current standard preoperative education and counseling. Participants will receive information regarding exercise and nutrition from a member of the surgical team. Participants will meet with a behavioral medicine specialist for additional education regarding factors affecting postoperative stress and relaxation techniques. Participants who are actively smoking will be counseled regarding smoking cessation and offered a referral to smoking cessation resources.

Participants in the intervention arm will receive all of the standard of care, as listed above, as well as individualized exercise and nutritional prehabilitation regimens.

During the data analysis, participants will be subdivided into treatment groups, upfront surgical resection versus neoadjuvant chemotherapy, in order to determine whether length of prehabilitation affected outcomes and distinguish any possible effect of chemotherapy toxicity.

Participants will meet with an exercise physiologist to undergo evaluation and develop individualized regimens for prehabilitation.

Exercise

Participants will meet with a nutritionist to undergo evaluation and develop individualized regimens for prehabilitation.

Nutritional

Participants will have 1 appointment with behavioral medicine - all participants will meet with the same behavioral medicine specialist to ensure consistency. Participants will receive education regarding factors that affect postoperative recovery and relaxation techniques.

Participants will also have the option to request faith support.

Behavioral Medicine

Participants who are actively smoking will be counseled regarding smoking cessation during their preoperative appointment with a member of the surgical team. They will also be offered a referral to smoking cessation resources.

Smoking Cessation

Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for participants with Pancreatic and Periampullary Neoplasms

Frailty is independently associated with an increased risk of adverse outcomes after major surgery, including pancreatic resection. Prehabilitation aims to optimize modifiable risk factors to improve participants' baseline health prior to surgery. Multiple studies with participants undergoing pancreatic surgery have investigated the impact of prehabilitation on preoperative health metrics as well as postoperative outcomes. The majority of these studies focused only on exercise; if nutritional and/or psychological status were assessed, these dimensions were not intervened upon in prehabilitation regimens or reassessed postoperatively. This randomized controlled trial (RCT) is designed to assess the impact of physical and nutritional prehabilitation on participants' perioperative condition for those undergoing pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms.

Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms

Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for Patients With Pancreatic and Periampullary Neoplasms

Previous studies have demonstrated that grip strength is a predictor of surgical outcomes and mortality in cancer participants. Grip strength will be measured utilizing the Jamar Dynamometer.

Classified according to the Clavien-Dindo Classification of postoperative complications.

Participants rise to full standing position from sitting in a chair as many times as possible within 30 seconds. The 30s CST has been utilized as a reliable test of lower extremity strength.

Participants will walk as far as possible in 6 min at a comfortable pace but do not run or jog. If participants cannot complete the full 6 min walk, then record the time and distance walked and the reason for stopping early.

Case Comprehensive Cancer Center

Neoplasms, Second Primary

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Central Nervous System Stimulants

Anti-Infective Agents

Megestrol

Megestrol Acetate

Thalidomide

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Contraceptive Agents

Contraceptives, Oral

Contraceptives, Oral, Hormonal

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Antineoplastic Agents, Hormonal

the patients were recepted chemotherapy alone

the patients were recepted chemotherapy combined with thalidomide and megestrol

the patients were recepted the best supportive without chemotherapy

the patients were recepted the best supportive combined with thalidomide and megestrol without chemotherapy

Chemotherapy drugs

The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks

thalidomide and megestrol acetate

Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks

optimal support treatment

yangwei w yang, master

wenbin wb gao, doctor

To observe the effect of thalidomide combined with megestrol acetate on lymphocyte, inflammatory factor regulation and nutritional status in patients with advanced malignant tumors.

This study was to select 200 patients with advanced tumors with an estimated survival of ≥ 2 months. 50 patients were randomly assigned to each group. The patients were divided into chemotherapy group, chemotherapy combined with thalidomide and megestrol acetate group, The best supportive treatment group, the best supportive treatment combined with thalidomide and megestrol acetate group. The chemotherapy group and the best supportive treatment group were the control group. The combined group was administered continuously for 8 weeks according to thalidomide 100 mg qn po and megestrol acetate 0.16 qd po. Calculating the sum of the longest diameters of the target lesions from each patient before and 8 week after treatment. Patients in each group before treatment, 4th week, and 7th week were observed T cell subsets, B cell subsets, NK cell subsets and the expression of inflammatory cytokines. Through nutritional assessment Table (PG-SGA), Multidimensional Deficit Power Meter (MFSI-SF), Quality of Life Assessment Scale (EORTC QLQ-C30), Prognostic Assessment Form (GPS), Physical Status Assessment Form (ECOG) and lean body mass, upper arm muscle circumference and upper arm muscle area analysis of the effect of thalidomide combined with megestrol acetate on the nutritional status of patients with advanced cancer which reveal that thalidomide combined with megestrol acetate may improve the immune regulation and nutritional status of patients with advanced malignant tumors mechanism.

200 patients with advanced tumors with a predicted survival period of ≥2 months were selected, including 100 patients with chemotherapy indications (50 patients were divided into chemotherapy group and 50 patients were divided into chemotherapy combined with TH and MG group according to the random principle) and 100 patients without chemotherapy indications (50 patients were randomly divided into the best supportive treatment group and 50 patients were randomly divided into the best supportive treatment group with TH and MG according to the random principle). The chemotherapy alone group and the best supportive treatment group were the control group. The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks.

The Evaluation of Curative Effect on Treatment of Tumor Above Thalidomide Combined With Megestrol

Prospective Clinical Study of the Effect of Thalidomide Combined With Megestrol Acetate on Lymphocyte, Inflammatory Factor Regulation and Nutritional Status in Patients With Advanced Malignant Tumors

Multidimensional deficient power assessment (MFSI-SF) was used in the present study. The MFSI-SF scale contains 30 subjects' subjective feelings，such as muscle soreness and memory loss. Subjects were scored according to the degree of each sensation (0-4). The MFSI-SF scale total score is the sum of each sensation score (0-120). The lower scores represent a better outcome and the higher scores represent a worse outcome.

Quality of Life Assessment Table (EORTC QLQ-C30) was used in the present study. The Quality of Life Assessment Table contains 28 subjects' subjective feelings and symptoms，such as tiredness and diarrhea within one week (A)，and two other indicators: health status，quality of life within one week (B). Subjects were scored according to the degree of each sensation (A 0-4) and (B 1-7). The Quality of Life Assessment Table is divided into two parts: the first part of the total score (0-112); the second part of the total scores (2-14). In the first part of the total scores: the lower scores represent a better outcome and the higher scores represent a worse outcome. In the second part of the total scores: the higher scores represent a better outcome and the lower scores represent a worse outcome.

The prognostic assessment by GPS scores which were calculated by detecting peripheral blood CRP and albumin from each tumor patients.

GPS scores：CRP \< 10 mg/l，albumin\> 35g/l，GPS 0；CRP \> 10 mg/l，albumin \> 35 g/l，GPS 1；CRP \> 10 mg/l，albumin \< 35 g/l，GPS 2. The lower scores represent a better outcome and the higher scores represent a worse outcome.

The performance status of patients with cancer is measured by the clinician through the ECOG score form (score:0-5)

Patient's waist circumference and weight were measured by trained registered clinical dietitians, and the measuring was controlled by one researcher (H.R). The researcher calculate lean body mass by measurements of waist circumference and body weight

Patient's upper arm circumference and triceps skinfold thickness were measured by trained registered clinical dietitians, and the measuring was controlled by one researcher (H.R). The researcher calculate Upper arm muscle circumference and upper arm muscle area by measurements of upper arm circumference and triceps skinfold thickness

Clinical response Based on the Response Evaluation Criteria Solid Tumors (RECIST), the therapeutic effect was divided into complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD). Investigators calculate the sum of the longest diameter of the target lesions from each patient by CT or MRI.

Patients were detected Lymphocyte subgroups of 2 ml peripheral blood by Flow cytometer (BD FACSCalibur), which inclunde the T cell subsets, NK cell subset, B cell subset(percentage)

2 ml of peripheral blood was taken from each patient. Flow cytometry was used to detect changes of inflammatory factor expression which include the IL-2, IL- 4, IL-5, IL-6, IL-9, IL-10, IL-13, IL-17A, IL-17F, IL-21, IL-22, IFN-γ and TNF-α(ug/ml)

Scored Patient-Generated Subjiective Global Assessment（PG-SGA）form was used in the present study. The total score of PG-SGA is summed by the following four subscale scores（A+B+C+D）. The first measurement score（A）is self-assessed by the subject and consists of the following four parts: Weight Table（0-4），Eating Situation Table（0-6），Symptom Table （0-22），Activity and Body Function Table（0-3）. The remaining three measurements are completed by trained registered clinical physicians， dieticians，and nurses: Scale of relationship between disease and nutritional needs（B）（0-6），Metabolic demand scale（C）（0-9），Physical examination scale（D）（0-24）. The scoring was controlled by one researcher (H.R). The lower scores represent a better outcome and the higher scores represent a worse outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms	NCT05225038	Pancreatic Neop... Periampullary C...	Exercise Nutritional Behavioral Medi... Smoking Cessati...	18 Years -	Case Comprehensive Cancer Center
Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms	NCT05225038	Pancreatic Neop... Periampullary C...	Exercise Nutritional Behavioral Medi... Smoking Cessati...	18 Years -	Case Comprehensive Cancer Center
The Evaluation of Curative Effect on Treatment of Tumor Above Thalidomide Combined With Megestrol	NCT03777930	Cancer, Therapy...	Chemotherapy dr... thalidomide and... optimal support... thalidomide and...	18 Years -	Shenzhen Fifth People's Hospital

Spots Global Cancer Trial Database for nutritional

Every month we try and update this database with for nutritional cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nutritional

Every month we try and update this database with for nutritional cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nutritional cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.