Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
关键词
抽象
描述
OBJECTIVES:
Primary
- To determine whether a herbal approach to decreasing 5-LO eicosanoid production reduces peritumoral brain edema in patients with HGG.
Secondary
- To determine if this adjuvant approach improves the quality of life and progression free and overall survival of patients with HGG.
OUTLINE: This a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (intervention): Patients receive oral Boswellia serrata herbal extract 4 times a day and oral cyanocobalamin (vitamin B-12) once a day for 6 months in the absence of unacceptable toxicity.
- Arm II (control): Patients receive oral vitamin B-12 once a day for 6 months. All patients are encouraged to eat a regular balanced diet (as recommended by the American Cancer Society for cancer prevention) with limited consumption of red and processed meats.
Quality of life will be assessed at baseline and then at 2, 4, 6, 12, and 24 months.
After completion of study treatment, patients will be followed every 6 months.
PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this study.
日期
| 最后验证: | 03/31/2019 |
| 首次提交: | 10/19/2005 |
| 提交的预估入学人数: | 10/19/2005 |
| 首次发布: | 10/20/2005 |
| 上次提交的更新: | 04/20/2019 |
| 最近更新发布: | 04/29/2019 |
| 首次提交结果的日期: | 10/10/2012 |
| 首次提交质量检查结果的日期: | 06/20/2013 |
| 首次发布结果的日期: | 07/29/2013 |
| 实际学习开始日期: | 08/31/2004 |
| 预计主要完成日期: | 02/28/2010 |
| 预计完成日期: | 02/28/2011 |
状况或疾病
干预/治疗
Drug: Arm I (intervention)
Dietary Supplement: cyanocobalamin
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Arm I (intervention) Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity. | Drug: Arm I (intervention) given orally |
| Active Comparator: Arm II (control) Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | INCLUSION CRITERIA: - Patients after surgical removal of histologically confirmed World Health Organization high-grade gliomas, including astrocytomas grade III (anaplastic astrocytoma), astrocytoma grade IV (glioblastoma multiforme, GBM), anaplastic oligodendroglioma and oligoastrocytoma - Karnofsky performance status of greater or equal 60 - Patients who signed informed consent - Patients can be receiving standard or investigational chemotherapy , hormonal therapy, immunotherapy or biologic agents as the primary treatment for their tumor - Glucocorticoid therapy is allowed - Bone marrow function (absolute neutrophil count [ANC] >=1500/mm^3 and platelet count >=75,000/mm^3); in the event of plate count dropping below 50,000/ mm^3 the Boswellia will be withdrawn until plate count reaches 75,000 mm^3 and above - Liver function (bilirubin and alkaline phosphatase =< 2 x normal and serum glutamic oxaloacetic transaminase [SGOT] =< 3 x normal) - Renal function (blood urea nitrogen [BUN] or creatinine =< 1.5 x normal) - Patients suffering from mild to moderate asthma, liver and kidney disease; an assessment of the condition will be made to establish a baseline and monitor progress at 4 weekly intervals to start with for the first two months and thereafter at the usual study intervals of 4 and 6 months; if there is any significant deterioration in their condition the Boswellia will be withdrawn until these parameters are restored to their pre-treatment levels EXCLUSION CRITERIA: - Any medical condition that could interfere with eating and oral administration of B. serrata - Patients already taking herbal preparations that contain 5-LO inhibitors - Any previous (within the past 3 years) or concurrent malignancies at other sites, with the exception of surgically cured carcinoma-in-situ of the cervix and non-melanoma skin cancer - Pregnancy and breastfeeding - Active infection - Inability to be followed closely at the Cleveland Clinic Foundation |
结果
主要结果指标
1. Change From Pooled Baseline in Peritumoral Brain Edema [at 2 months]
2. Change From Baseline in Peritumoral Brain Edema [at 4 months]
3. Change From Baseline in Peritumoral Brain Edema [at 6 months]
次要成果指标
1. Quality of Life at 6 Months [At 2, 4, 6, 12, and 24 months]
2. Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months [6 months]
3. Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year [1 year]
4. Overall Survival: Percentage of Patients That Were Alive at 1 Year [1 year.]
其他成果措施
1. Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record [At 2, 4, 6, 12, and 24 months]
