A Randomized Double-Blinded Phase 2 Study Evaluating a Proprietary Amino Acid Mixture (Enterade®) in Patients Receiving High-Dose Melphalan Conditioning Followed by Autologous Stem Cell Transplantation for Multiple Myeloma and Non-Hodgkin Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity
研究概览
简要总结
This research study is evaluating Enterade, a supplement, as a possible treatment for the side effects caused by Stem Cell Transplant.
The following interventions will be involved in this study:
- Enterade plus standard supportive care
- Placebo plus standard supportive care. The placebo will be a mixture of water, electrolytes, and sweetener.
详细描述
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease, or in this case, the side effects from a standard treatment for Stem Cell Transplant side effect. "Investigational" means that the intervention is being studied.
In this research study, the investigators are evaluating Enterade/Placebo plus standard supportive care for the treatment of the side effects caused by transplant. Enterade works by rehydrating the intestinal cells, thereby helping to restore normal bowel function. The ingredients in Enterade are generally recognized as safe by the Food and Drug Administration. This research study is hoping to learn if adding Enterade to the standard supportive care regimen for the participant transplant will help reduce the side effects from the transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Participants must have histologically or cytologically confirmed Multiple Myeloma, or Non-Hodgkin Lymphoma and must be undergoing Melphalan conditioning for autologous HSCT.
- •Age equal or greater than 18 years old.
- •ECOG performance status ≤2 (Karnofsky ≥60%)
- •Participants must have adequate organ and marrow function to proceed to transplant.
- •Ability to tolerate thin liquids by mouth at the time of admission.
- •The effects of Enterade® on the developing human fetus are unknown. For this reason and other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) at the time of study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of the trial.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Participants who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to chemotherapy agents administered during this time period.
- •Participants who are receiving any other investigational agents. Participants who are receiving standard of care induction therapy on a clinical trial may be eligible after discussion with the overall principal investigator.
- •Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •Known allergy to Stevia.
- •Participants receiving any medications or antibiotics to treat Clostridium difficile infection prior to the initiation of the study will be ineligible for this study.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active Clostridium difficile infection or history of Clostridium difficile infection.
- •Participants with evidence of diarrhea as defined by three or more loose or liquid stools per day or loose watery stool (greater volume of stool), that occurs more frequently than usual and lasting for more than three days prior to admission, history of inflammatory bowel disease, irritable bowel syndrome, colectomy or bariatric surgery, Celiac disease.
- •Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant and nursing women are excluded from this study because of teratogenicity and toxicity risks associated with the conditioning regimen for patients undergoing autologous HSCT.
研究组 & 干预措施
Enterade and Standard Supportive Care
- Two 8 oz. bottles of Enterade will be administered daily
- Enterade will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
干预措施: Enterade (Dietary Supplement)
Enterade and Standard Supportive Care
- Two 8 oz. bottles of Enterade will be administered daily
- Enterade will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
干预措施: Standard Supportive Care (Other)
Placebo and Standard Supportive Care
- Two 8 oz. bottles of Placebo will be administered daily
- Placebo will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
干预措施: Standard Supportive Care (Other)
Placebo and Standard Supportive Care
- Two 8 oz. bottles of Placebo will be administered daily
- Placebo will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity
时间窗: 14 days
Evaluation will made using Fisher's exact test. Among 99 participants who received some intervention
次要结局
- Number of Participants With Fever or Neutropenia(14 days)
- Median Amount Of Anti-Diarrheal Medications(14 days)
- Maximum Daily Stool Frequency(14 days)
- the Tolerability of Enterade® as Measured by the Number of Compliant Patients(14 days)
- Duration Of Hospitalization (Days) From Admission To Discharge(Up to 45 days)
- Percent Change in Weight From Baseline to Day 14(baseline and day 14)
- Calorie Consumption(14 days)
- Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency(14 days)
研究者
Mahasweta Gooptu
Principal Investigator
Dana-Farber Cancer Institute