Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
Avainsanat
Abstrakti
Kuvaus
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.
Päivämäärät
| Viimeksi vahvistettu: | 03/31/2019 |
| Ensimmäinen lähetys: | 10/19/2005 |
| Arvioitu ilmoittautuminen lähetetty: | 10/19/2005 |
| Ensimmäinen lähetetty: | 10/20/2005 |
| Viimeisin päivitys lähetetty: | 04/20/2019 |
| Viimeisin päivitys lähetetty: | 04/29/2019 |
| Ensimmäisten tulosten toimittamispäivä: | 10/10/2012 |
| Ensimmäisten QC-tulosten toimittamispäivä: | 06/20/2013 |
| Ensimmäisten tulosten päivämäärä: | 07/29/2013 |
| Todellinen opintojen alkamispäivä: | 08/31/2004 |
| Arvioitu ensisijainen valmistumispäivä: | 02/28/2010 |
| Arvioitu tutkimuksen valmistumispäivä: | 02/28/2011 |
Ehto tai tauti
Interventio / hoito
Drug: Arm I (intervention)
Dietary Supplement: cyanocobalamin
Vaihe
Varren ryhmät
| Varsi | Interventio / hoito |
|---|---|
| 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. |
Kelpoisuusehdot
| Tutkimukseen soveltuvat iät | 18 Years Vastaanottaja 18 Years |
| Sukupuolet, jotka ovat kelpoisia tutkimukseen | All |
| Hyväksyy terveelliset vapaaehtoiset | Joo |
| Kriteeri | 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 |
Tulokset
Ensisijaiset tulosmittaukset
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]
Toissijaiset tulosmittaukset
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.]
Muut lopputulokset
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]
