Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Completed
• CT.gov ID: NCT01317199
• Collaborator: Howard University (Other), Prostate Cancer Clinical Trials Consortium (Other)
• Enrollment: 143
• Locations: 8
• Arms: 4
• Duration (Months): 52
• Patients Per Site: 17.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This research is being done to test an investigational product called Muscadine Plus in the treatment of men who have received initial therapy (surgery and or radiation, cryotherapy or brachytherapy) for prostate cancer and are experiencing a rise in their prostate-specific antigens (PSA) level.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Muscadine Plus Grape Skin Extract; Drug: Low-dose MPX; Drug: High-dose MPX; Drug: Placebo oral capsule	Phase 1/Phase 2

Detailed Description

In phase I the investigators are evaluating the safety of the product and checking blood levels of the active components. In phase II the investigators are evaluating the effect of MPX on PSA doubling time

Study Design

• Study Type: Interventional
• Actual Enrollment: 143 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Arm 1: participants in dose-escalation phase (Phase 1) Arms 2-4: Randomized, double-blind (Phase 2); control, low-dose, high-doseArm 1: participants in dose-escalation phase (Phase 1) Arms 2-4: Randomized, double-blind (Phase 2); control, low-dose, high-dose
• Masking: Double (Participant, Investigator)
• Masking Description: Phase 1 (Arms 1) - open label Phase 2 (Arms 2-4) - randomized, double-blind
• Primary Purpose: Treatment
• Official Title: Phase I/II Study of Safety and Efficacy of Muscadine Plus (MPX) in Men With Prostate Cancer: a Randomized,Double-blind,Placebo Controlled Study of the Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 1: Dose-escalation of Muscadine Plus Grape Skin Extract Muscadine Plus Grape Skin Extract (MPX): Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.	Drug: Muscadine Plus Grape Skin Extract; Phase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle
Placebo Comparator: Phase 2: Placebo control Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).	Drug: Placebo oral capsule; Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
Experimental: Phase 2: Low-dose MPX Randomly-assigned participants receive low-dose (500mg) MPX	Drug: Low-dose MPX; Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
Experimental: Phase 2: High-dose MPX Randomly-assigned participants receive high-dose (4000mg) MPX	Drug: High-dose MPX; Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).

Outcome Measures

Primary Outcome Measures

1. (Phase I) Maximum Tolerated Dose [Up to 7 months post-intervention]

   To determine the recommended dosing for Muscadine Plus and to evaluate the safety and tolerability of Muscadine Plus in prostate cancer patients with rising PSA following definitive therapy.

2. (Phase II) Prostate Specific Antigen Doubling Time (PSADT) [Change from baseline to month 12]

   To define the effects of placebo and two different daily doses of MPX on PSADT in men who have rising PSA after initial definitive therapy for localized prostate cancer.

Secondary Outcome Measures

1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [At month 12 post-intervention]

   Adverse events reported verbally by patient and documented in study notes.

2. (Phase II) Proportion of Men Whose PSADT Increases Greater Than 33% [At month 12 post-intervention]

3. (Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline [At month 12 post-intervention]

   Change in PSA values drawn over study period, taken every 3 months. PSA is measured in ng/mL

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate.

• Undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor.

• Rising PSA on a minimum of 3 time points (including screening psa) within the 12 months prior to study initiation.

• 18 years of age.

• Life expectancy of greater than 6 months.

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.

• Testosterone level of ≥1.5 ng/mL at screening.

• Adequate kidney, liver and bone marrow function

• Agrees to abstain from other commercially available MP products while participating in this study.

• Subject's use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc) has been stable for at least 2 months prior to screening and the subject agrees not to stop or change the dose(s) while participating in the study.

• Signed a written informed consent document and agrees to comply with requirements of the study.

Exclusion Criteria:

• Known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology. Pelvic/intraperitoneal lymph nodes less than 2.0 cm maybe considered nonspecific and the patient would be eligible

• Receipt of any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, 5 alpha reductase inhibitors) for a minimum of 6 months prior to study

• Prior or concomitant treatment with experimental drugs, high dose steroids, or any other cancer treatment within 4 weeks prior to the first dose of the study product

• Consumption of Muscadine Plus over the past 2 months

• Known allergy to muscadine grapes or ellagic acid

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Negative PSA doubling time (1 time point may be excluded per 3e inclusion criteria)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sibley Memorial Hospital	Washington	District of Columbia	United States	20016
2	Howard University College of Medicine	Washington	District of Columbia	United States	20060
3	Johns Hopkins Hospital	Baltimore	Maryland	United States	21205
4	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
5	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
6	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
7	Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
8	Roswell Park Cancer Institute	Buffalo	New York	United States	14263

Sponsors and Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Howard University
• Prostate Cancer Clinical Trials Consortium

Investigators

• Principal Investigator: Michael A Carducci, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT01317199
• Other Study ID Numbers: J1161
• First Posted: Mar 17, 2011
• Last Update Posted: Apr 2, 2021
• Last Verified: Jun 1, 2018

• Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: Rising psa
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Recruitment Details	Recruitment dates: Phase I: October 4, 2011-August 7, 2012 in medical clinics Phase II: January 31, 2013-October 20, 2014
Pre-assignment Detail	Enrolled subjects agreed to abstain from other commercially available Muscadine Plus products while in this trial. If subjects were taking other dietary/herbal supplements (e.g. saw palmetto, selenium, pomegranate juice or pills, etc) prior to study entry, they had to be on a stable dose for 2 months prior and not stop while on trial.

Arm/Group Title	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX
Arm/Group Description	Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.	Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Period Title: Dose-escalation Phase 1
STARTED	14	0	0	0
Cycle 1: 500mg MPX Once Daily for 28 Day	2	0	0	0
Cycle 2: 1000mg MPX Daily for 28 Days	2	0	0	0
Cycle 3: 2000mg MPX Daily for 28 Days	2	0	0	0
Cycle 4: 3000mg MPX Daily for 28 Days	2	0	0	0
Cycle 5: 4000mg MPX Daily for 28 Days	6	0	0	0
COMPLETED	7	0	0	0
NOT COMPLETED	7	0	0	0
Period Title: Dose-escalation Phase 1
STARTED	0	24	56	49
COMPLETED	0	13	35	32
NOT COMPLETED	0	11	21	17

Baseline Characteristics

Arm/Group Title	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX	Total
Arm/Group Description	Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.	Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).	Total of all reporting groups
Overall Participants	14	24	56	49	143
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.6 (7.5)	69 (7.1)	67 (7.2)	68 (6.9)	67.2 (7.1)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%
Male	14 100%	24 100%	56 100%	49 100%	143 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	4 28.6%	6 25%	12 21.4%	10 20.4%	32 22.4%
White	10 71.4%	18 75%	43 76.8%	38 77.6%	109 76.2%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	1 1.8%	1 2%	2 1.4%
Region of Enrollment (participants) [Number]
United States	14 100%	24 100%	56 100%	49 100%	143 100%
Eastern Cooperative Oncology Group (ECOG) (Count of Participants)
0	18 128.6%	52 216.7%	39 69.6%	109 222.4%
1	5 35.7%	2 8.3%	8 14.3%	15 30.6%
Gleason score (Count of Participants)
≤6, 3+4	11 78.6%	25 104.2%	23 41.1%	59 120.4%
≥8, 4+3	13 92.9%	31 129.2%	26 46.4%	70 142.9%
6	3 21.4%	3 12.5%
7	7 50%	7 29.2%
8	1 7.1%	1 4.2%
9	3 21.4%	3 12.5%
Baseline PSA doubling time (PSADT) (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	13 (10.1)	13 (10.1)
Baseline PSADT (Count of Participants)
≤9 months	13 92.9%	32 133.3%	27 48.2%	72 146.9%
>9 months	10 71.4%	23 95.8%	21 37.5%	54 110.2%
Prior therapy (Count of Participants)
Radiation	4 28.6%	21 87.5%	49 87.5%	42 85.7%	116 81.1%
Surgery	1 7.1%	16 66.7%	40 71.4%	32 65.3%	89 62.2%
Radiation & Surgery	9 64.3%	9 37.5%
Cryotherapy	0 0%	49 204.2%	1 1.8%	50 102%
Brachytherapy	3 21.4%	5 20.8%	3 5.4%	11 22.4%
Androgen Deprivation Therapy (ADT)	2 14.3%	25 104.2%	19 33.9%	46 93.9%
Superoxide dismutase 2 (SOD2) genotype (Count of Participants)
Alanine/Alanine (Ala/Ala)	5 35.7%	12 50%	10 17.9%	27 55.1%
Alanine/Valine (Ala/Val)	11 78.6%	21 87.5%	22 39.3%	54 110.2%
Valine/Valine (Val/Val)	5 35.7%	11 45.8%	5 8.9%	21 42.9%

Outcome Measures

1. Primary Outcome

Title	(Phase I) Maximum Tolerated Dose
Description	To determine the recommended dosing for Muscadine Plus and to evaluate the safety and tolerability of Muscadine Plus in prostate cancer patients with rising PSA following definitive therapy.
Time Frame	Up to 7 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX
Arm/Group Description	Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.	Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Measure Participants	14	0	0	0
Number [mg]	4000

2. Primary Outcome

Title	(Phase II) Prostate Specific Antigen Doubling Time (PSADT)
Description	To define the effects of placebo and two different daily doses of MPX on PSADT in men who have rising PSA after initial definitive therapy for localized prostate cancer.
Time Frame	Change from baseline to month 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX
Arm/Group Description	Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Measure Participants	20	52	40
Median (Full Range) [months]	0.9	1.5	0.9

3. Secondary Outcome

Title	Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description	Adverse events reported verbally by patient and documented in study notes.
Time Frame	At month 12 post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX
Arm/Group Description	Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.	Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Measure Participants	14	23	55	47
Count of Participants [Participants]	7 50%	19 79.2%	38 67.9%	32 65.3%

4. Secondary Outcome

Title	(Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%
Time Frame	At month 12 post-intervention

Outcome Measure Data

Analysis Population Description

Data was not collected for this secondary outcome measure.

Arm/Group Title	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX
Arm/Group Description	Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Measure Participants	0	0	0

5. Secondary Outcome

Title	(Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline
Description	Change in PSA values drawn over study period, taken every 3 months. PSA is measured in ng/mL
Time Frame	At month 12 post-intervention

Outcome Measure Data

Analysis Population Description

Patients counted in the analysis were evaluable if they completed at least six cycles of treatment prior to discontinuation

Arm/Group Title	Phase 2: Placebo Control	Phase 2: Low-dose MPX	Phase 2: High-dose MPX
Arm/Group Description	Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).	Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Measure Participants	20	52	40
Count of Participants [Participants]	0 0%	0 0%	1 1.8%

Adverse Events

Arm/Group Title	Phase 1:Muscadine Plus Grape Skin Extract (MPX) 500mg		Dose-escalation Phase 1: MPX 1000mg		Dose-escalation Phase 1: MPX 2000mg		Dose-escalation Phase 1: MPX 3000mg		Dose-escalation Phase 1: MPX 4000mg		Phase 2: Placebo Control		Phase 2: Low-dose MPX		Phase 2: High-dose MPX
Arm/Group Description	Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.		Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.		Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.		Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.		Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.		Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).		Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).		Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
All Cause Mortality
	Phase 1:Muscadine Plus Grape Skin Extract (MPX) 500mg		Dose-escalation Phase 1: MPX 1000mg		Dose-escalation Phase 1: MPX 2000mg		Dose-escalation Phase 1: MPX 3000mg		Dose-escalation Phase 1: MPX 4000mg		Phase 2: Placebo Control		Phase 2: Low-dose MPX		Phase 2: High-dose MPX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)		0/2 (0%)		0/2 (0%)		0/6 (0%)		0/23 (0%)		0/55 (0%)		0/47 (0%)
Serious Adverse Events
	Phase 1:Muscadine Plus Grape Skin Extract (MPX) 500mg		Dose-escalation Phase 1: MPX 1000mg		Dose-escalation Phase 1: MPX 2000mg		Dose-escalation Phase 1: MPX 3000mg		Dose-escalation Phase 1: MPX 4000mg		Phase 2: Placebo Control		Phase 2: Low-dose MPX		Phase 2: High-dose MPX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)		0/2 (0%)		0/2 (0%)		0/6 (0%)		0/23 (0%)		1/55 (1.8%)		1/47 (2.1%)
Infections and infestations
Cellulitis	0/2 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/23 (0%)	0	1/55 (1.8%)	1	0/47 (0%)	0
Musculoskeletal and connective tissue disorders
Vocal Chord Squamous Cell Carcinoma	0/2 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/23 (0%)	0	0/55 (0%)	0	1/47 (2.1%)	1
Other (Not Including Serious) Adverse Events
	Phase 1:Muscadine Plus Grape Skin Extract (MPX) 500mg		Dose-escalation Phase 1: MPX 1000mg		Dose-escalation Phase 1: MPX 2000mg		Dose-escalation Phase 1: MPX 3000mg		Dose-escalation Phase 1: MPX 4000mg		Phase 2: Placebo Control		Phase 2: Low-dose MPX		Phase 2: High-dose MPX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		1/2 (50%)		0/2 (0%)		0/2 (0%)		3/6 (50%)		3/23 (13%)		10/55 (18.2%)		7/47 (14.9%)
Gastrointestinal disorders
Flatulence	0/2 (0%)	0	1/2 (50%)	1	0/2 (0%)	0	0/2 (0%)	0	3/6 (50%)	3	3/23 (13%)	3	6/55 (10.9%)	6	3/47 (6.4%)	3
Diarrhea	0/2 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/23 (0%)	0	4/55 (7.3%)	4	0/47 (0%)	0
dyspepsia	0/2 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/23 (0%)	0	0/55 (0%)	0	4/47 (8.5%)	4

Limitations/Caveats

[Not Specified]

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.