Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme

• Sponsor: Ali Altunkaya (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00243022
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 77.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

RATIONALE: Giving the herb Boswellia serrata after surgery and radiation therapy may slow the growth of any remaining tumor cells. It is not yet known whether giving Boswellia serrata together with standard treatment is more effective than standard treatment alone in treating high-grade gliomas.

PURPOSE: This randomized phase II trial is the study of a combination of complementary and alternative medicine (CAM) herbal supplement intervention as an adjuvant to standard treatment of patients with newly diagnosed and recurrent high-grade gliomas (HGG). The central hypothesis of this application is that a herbal preparation that inhibits 5-LO activity, will produce measurable biologically meaningful decrease in 5-LO eicosanoid production and brain edema that will be associated with improved survival and quality of life in patients with HGG.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors; Cerebral Edema	Drug: Boswellia serrata extract; Dietary Supplement: cyanocobalamin	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Randomized Evaluation of 5-Lipoxygenase Inhibition by Herbal Complementary and Alternative Medicine Approach Compared to Control as an Adjuvant Therapy in Newly Diagnosed and Recurrent High-grade Gliomas
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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: Boswellia serrata extract; given orally; Dietary Supplement: cyanocobalamin; given orally; Other Names: Vitamin B12
Active Comparator: Arm II (control) Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.	Dietary Supplement: cyanocobalamin; given orally; Other Names: Vitamin B12

Outcome Measures

Primary Outcome Measures

1. Change From Pooled Baseline in Peritumoral Brain Edema [at 2 months]

   The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema

2. Change From Baseline in Peritumoral Brain Edema [at 4 months]

   The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation.For each patient change = edema at follow up - baseline edema.

3. Change From Baseline in Peritumoral Brain Edema [at 6 months]

   The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema.

Secondary Outcome Measures

1. Quality of Life at 6 Months [At 2, 4, 6, 12, and 24 months]

   Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items (EORTC QLQ-C30)

2. Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months [6 months]

   Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.

3. Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year [1 year]

   Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.

4. Overall Survival: Percentage of Patients That Were Alive at 1 Year [1 year.]

   Overall survival will be measured from the date of enrollment to date of death or last contact. Survival will be evaluated by the Kaplan Meier method to evaluate the median survival and 1 year survival rates.

Other Outcome Measures

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]

   The 3-day food diary will be used to assess the dietary intake and to increase eating awareness of patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• Ali Altunkaya
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Glen Stevens, DO, PhD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ali Altunkaya, Principal Investigator, Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT00243022
• Other Study ID Numbers: CASE1304; CCF-7348; NCI-2010-01384; R21CA107277-01
• First Posted: Oct 21, 2005
• Last Update Posted: Apr 30, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Ali Altunkaya, Principal Investigator, Case Comprehensive Cancer Center: cerebral edema; adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma
• Additional relevant MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Edema; Vitamin B 12; Hydroxocobalamin

Study Results

Participant Flow

Recruitment Details	Patients recruited from September 2004-September 2010 from local medical clinic.

Arm/Group Title	Arm I (Intervention)	Arm II (Control)
Arm/Group Description	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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day	Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/day given orally
Period Title: Overall Study
STARTED	7	5
COMPLETED	5	4
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Arm I (Intervention)	Arm II (Control)	Total
Arm/Group Description	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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day	Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/daygiven orally	Total of all reporting groups
Overall Participants	7	5	12
Age, Customized (participants) [Number]
30-39 years	1 14.3%	0 0%	1 8.3%
40-49 years	3 42.9%	3 60%	6 50%
50-59 years	1 14.3%	2 40%	3 25%
60-69 years	1 14.3%	0 0%	1 8.3%
70-79 years	1 14.3%	0 0%	1 8.3%
Sex: Female, Male (Count of Participants)
Female	4 57.1%	2 40%	6 50%
Male	3 42.9%	3 60%	6 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	7 100%	5 100%	12 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 20%	1 8.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	7 100%	4 80%	11 91.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	5 100%	12 100%
Baseline edema measure (cm^3) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm^3]	10.8 (11.1)	11.3 (8.1)	11.1 (9.4)

Outcome Measures

1. Primary Outcome

Title	Change From Pooled Baseline in Peritumoral Brain Edema
Description	The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema
Time Frame	at 2 months

Outcome Measure Data

Analysis Population Description

Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.

Arm/Group Title	Arm I (Intervention)	Arm II (Control)
Arm/Group Description	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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day	Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/daygiven orally
Measure Participants	4	2
Mean (Standard Deviation) [cm^3]	-3.87 (8.0)	-3.045 (2.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Intervention), Arm II (Control)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Change From Baseline in Peritumoral Brain Edema
Description	The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation.For each patient change = edema at follow up - baseline edema.
Time Frame	at 4 months

Outcome Measure Data

Analysis Population Description

Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.

Arm/Group Title	Arm I (Intervention)	Arm II (Control)
Arm/Group Description	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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day	Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/daygiven orally
Measure Participants	5	4
Mean (Standard Deviation) [cm^3]	-2.7 (7.3)	10.21 (14.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Intervention), Arm II (Control)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

Title	Change From Baseline in Peritumoral Brain Edema
Description	The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema.
Time Frame	at 6 months

Outcome Measure Data

Analysis Population Description

Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.

Arm/Group Title	Arm I (Intervention)	Arm II (Control)
Arm/Group Description	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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day	Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/daygiven orally
Measure Participants	2	2
Mean (Standard Deviation) [cm^3]	-3.7 (9.5)	-1.5 (2.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Intervention), Arm II (Control)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Quality of Life at 6 Months
Description	Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items (EORTC QLQ-C30)
Time Frame	At 2, 4, 6, 12, and 24 months

Outcome Measure Data

Analysis Population Description

At baseline and the most recent post treatment point in time, the QOL data for group 1 consist of n=3 patients and for group 2, n=2. Because of low patient numbers, no analysis was done.

Arm/Group Title	Arm I (Intervention)	Arm II (Control)
Arm/Group Description	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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day	Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/daygiven orally
Measure Participants	0	0

5. Secondary Outcome

Title	Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months
Description	Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All 12 patients followed to progression or death, or censored at last visit when known alive

Arm/Group Title	Arm I (Intervention)	Arm II (Control)
Arm/Group Description	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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day	Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/daygiven orally
Measure Participants	7	5
Number (95% Confidence Interval) [percentage of participants]	43 614.3%	100 2000%

6. Secondary Outcome

Title	Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year
Description	Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

All 12 patients followed to progression or death, or censored at last visit when known alive

Arm/Group Title	Arm I (Intervention)	Arm II (Control)
Arm/Group Description	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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day	Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/daygiven orally
Measure Participants	7	5
Number (95% Confidence Interval) [percentage of participants]	71 1014.3%	80 1600%

7. Secondary Outcome

Title	Overall Survival: Percentage of Patients That Were Alive at 1 Year
Description	Overall survival will be measured from the date of enrollment to date of death or last contact. Survival will be evaluated by the Kaplan Meier method to evaluate the median survival and 1 year survival rates.
Time Frame	1 year.

Outcome Measure Data

Analysis Population Description

All 12 patients followed to death or censored at last visit when known alive

Arm/Group Title	Arm I (Intervention)	Arm II (Control)
Arm/Group Description	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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day	Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/daygiven orally
Measure Participants	7	5
Number (95% Confidence Interval) [percentage of particpants]	57	60

8. Other Pre-specified Outcome

Title	Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record
Description	The 3-day food diary will be used to assess the dietary intake and to increase eating awareness of patients.
Time Frame	At 2, 4, 6, 12, and 24 months

Outcome Measure Data

Analysis Population Description

No data collected

Arm/Group Title	Arm I (Intervention)	Arm II (Control)
Arm/Group Description	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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day	Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/day given orally
Measure Participants	0	0

Adverse Events

Time Frame	Adverse event data was collected over a 4 year period while patients were on treatment
Arm/Group Title	Arm I (Intervention)		Arm II (Control)
Arm/Group Description	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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day		Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/daygiven orally
All Cause Mortality
	Arm I (Intervention)		Arm II (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I (Intervention)		Arm II (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		2/5 (40%)
Nervous system disorders
Seizure	0/7 (0%)	0	1/5 (20%)	1
Psychiatric disorders
Psychosis	0/7 (0%)	0	1/5 (20%)	1
Other (Not Including Serious) Adverse Events
	Arm I (Intervention)		Arm II (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/7 (42.9%)		3/5 (60%)
Blood and lymphatic system disorders
Thrombocytopenia	1/7 (14.3%)		0/5 (0%)
Endocrine disorders
Cushingoid appearance	1/7 (14.3%)		0/5 (0%)
Gastrointestinal disorders
Heartburn	1/7 (14.3%)		0/5 (0%)
Constipation	2/7 (28.6%)		0/5 (0%)
Diarrhea	1/7 (14.3%)		0/5 (0%)
Thrush	1/7 (14.3%)		0/5 (0%)
Hemorrhoids	1/7 (14.3%)		0/5 (0%)
Rectal bleeding	1/7 (14.3%)		0/5 (0%)
General disorders
Tiredness	2/7 (28.6%)		2/5 (40%)
Weight Loss	1/7 (14.3%)		0/5 (0%)
Metabolism and nutrition disorders
Hypokalemia	1/7 (14.3%)		0/5 (0%)
Hyperglycemia	1/7 (14.3%)		0/5 (0%)
Hypertriglyceridemia	1/7 (14.3%)		0/5 (0%)
Nervous system disorders
Neuropathy-sensory	1/7 (14.3%)		0/5 (0%)
Neck pain	0/7 (0%)		1/5 (20%)
Psychiatric disorders
Ataxia	1/7 (14.3%)		0/5 (0%)
Insomnia	0/7 (0%)		1/5 (20%)
Mood alteration-anxiety, agitation	2/7 (28.6%)		1/5 (20%)
Disoriented; cries easily; angry	1/7 (14.3%)		0/5 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation	1/7 (14.3%)		0/5 (0%)
Skin and subcutaneous tissue disorders
Skin Rash	1/7 (14.3%)		0/5 (0%)
Alopecia	2/7 (28.6%)		2/5 (40%)
Dry Skin	1/7 (14.3%)		0/5 (0%)
Radiation Dermatitis	1/7 (14.3%)		1/5 (20%)
Shingles	1/7 (14.3%)		0/5 (0%)

Limitations/Caveats

Certain outcome analysis not done due to low patient accrual.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.