A Randomized Phase III Double Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 203
- 试验地点
- 92
- 主要终点
- Post-operative Complications (30 Days)
研究概览
简要总结
This phase III trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.
详细描述
PRIMARY OBJECTIVE:
I. To compare the impact of consuming perioperative specialized immune-modulating drinks (SIM, Impact Advanced Recovery, Nestle) to oral nutrition supplement control drinks (ONS, Oral Nutrition Control, Nestle) on post-operative complications (any versus [vs.] none) within 30 days after scheduled radical cystectomy (RC).
SECONDARY OBJECTIVES:
I. To assess whether SIM use compared to ONS reduces late-phase post-operative complications within 90 days after scheduled RC.
II. To assess whether SIM use compared to ONS reduces infections. III. To assess whether SIM use compared to ONS reduces skeletal muscle wasting. IV. To assess whether SIM use compared to ONS reduces high grade post-operative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a tissue diagnosis of primary cell carcinoma of the bladder by transurethral resection of bladder tumor (TURBT) or partial cystectomy; patients may not have any evidence of unresectable disease or metastatic disease as assessed by exam under anesthesia or imaging (computed tomography [CT], magnetic resonance imaging [MRI], positron-emission tomography [PET])
- •There must be plans for the cystectomy to be performed within 28 calendar days after registration
- •Surgery must be planned to be performed under pre-approved, study-specific surgical guidelines
- •Patients must have completed any neoadjuvant chemotherapy or immunotherapy (intravesical or systemic) >= 14 calendar days prior to registration and any toxicities resolved to at least grade 2
- •Patients may have a history of radiation therapy; radiation therapy must have been completed >= 180 days prior to registration
- •Patients may have a history of prior partial cystectomy; prior partial cystectomy must have been completed at least 180 days prior to registration
- •Patients with planned adjuvant chemotherapy within 90 days after radical cystectomy will not be eligible
- •Patients must be able to swallow liquid and have no refractory nausea, vomiting, malabsorption, or significant small bowel resection that would preclude adequate absorption; patients on tube feeding are not eligible
- •Patients must have their baseline nutrition status assessed using the Scored Patient-Generated Subjective Global Assessment (PG-SGA) by a clinician or licensed healthcare practitioner (trained physician, nurse, or dietician) within 14 days prior to registration and must not have a global category rating of stage C (severely malnourished)
- •Patients must not have galactosemia
- •Patients must not have known active viral infections such as human immunodeficiency virus (HIV) or hepatitis, as these chronic viral infections may cause cachexia and immunodeficiency and thus alter the biology regarding the study endpoints
- •No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for two years; prostate cancer found at cystectomy would not be considered a prior malignancy
- •Patients must not be pregnant or nursing as the conditions preclude candidacy for radical cystectomy
- •Patients must consent and be willing to have specimens collected and submitted
- •Patients must be offered the opportunity to participate in additional specimen banking
- •Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- •As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
- •Patients must consent and provide their telephone contact information for four 24-hour dietary recall phone interviews to be conducted by staff at the Exercise, Diet, Genitourinary, & Endocrinology Laboratory (EDGE) Research Laboratory
- •Patients must be able to understand and speak English and/or Spanish because the dietary recall phone interviews will only be conducted in English or Spanish
排除标准
- 未提供
研究组 & 干预措施
Arm I (SIM)
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (SIM)
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
干预措施: Nutritional Intervention (Dietary Supplement)
Arm I (SIM)
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
干预措施: Quality-of-Life Assessment (Other)
Arm I (SIM)
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
干预措施: Questionnaire Administration (Other)
Arm II (placebo)
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (placebo)
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
干预措施: Placebo Administration (Other)
Arm II (placebo)
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
干预措施: Quality-of-Life Assessment (Other)
Arm II (placebo)
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Post-operative Complications (30 Days)
时间窗: Up to 30 days post surgery
A post-operative complication is defined as a binary indicator variable indicating whether the patient experienced any complication (any/none; Clavien-Dindo grades I-V). The primary analysis will be based on a multivariable logistic regression under intent-totreat among all randomized patients, irrespective of their eligibility status, adjusting for the specified stratification factors: a. Diversion type (neobladder versus \[vs.\] ileal conduit); b. Prior neoadjuvant chemotherapy (any vs. none); and c. Nutrition status (well nourished vs. moderate malnutrition). A Fisher's exact test will also be conducted to establish whether the results are sensitive to model assumptions. A single interim analysis for efficacy will be conducted when 50% of patients achieve their endpoint at the alpha=0.005 level. Accordingly, the final analysis will be conducted at the alpha=0.045 level. A separate analysis among all eligible randomized patients will also be conducted.
Post-operative Complications
时间窗: Up to 30 days post surgery
A post-operative complication is defined as a binary indicator variable indicating whether the patient experienced any complication (any/none; Clavien-Dindo grades I-V). The primary analysis will be based on a multivariable logistic regression under intent-totreat among all randomized patients, irrespective of their eligibility status, adjusting for the specified stratification factors: a. Diversion type (neobladder versus \[vs.\] ileal conduit); b. Prior neoadjuvant chemotherapy (any vs. none); and c. Nutrition status (well nourished vs. moderate malnutrition). A Fisher's exact test will also be conducted to establish whether the results are sensitive to model assumptions. A single interim analysis for efficacy will be conducted when 50% of patients achieve their endpoint at the alpha=0.005 level. Accordingly, the final analysis will be conducted at the alpha=0.045 level. A separate analysis among all eligible randomized patients will also be conducted.
次要结局
- Skeletal Muscle Wasting(30 days post op)
- Post-Op Complications (90 Days)(Within 90 days after scheduled RC)
- Infections(30 days post-op)
- High Grade Post-Op Complications(30 days post-op)
- Readmission Rates(30 days post-op)
- Quality of Life(30 days post op)
- 2-Year Disease Free Survival(2 years)
- Skeletal Muscle Wasting(This outcome measure will be reported by 9/28/2025)
- Post-Op Complications(This outcome measure will be reported by 9/28/2025)
- Infections(This outcome measure will be reported by 9/28/2025)
- High Grade Post-Op Complications(This outcome measure will be reported by 9/28/2025)
- Readmission Rates(This outcome measure will be reported by 9/28/2025)
- Quality of Life(This outcome measure will be reported by 9/28/2025)
- Disease Free Survival(This outcome measure will be reported by 9/28/2025)