Trial Outcomes & Findings for L-Arginine Supplements in Treating Women Who Are Cancer Survivors (NCT NCT00459134)

Last Updated: 2021-09-28

Results Overview

Patients filled out the Female Sexual Function Index (FSFI) at baseline and at 4, 8, and 12 weeks following randomization. The FSFI is comprised of 2 questions related to desire, 4 questions related to arousal, 4 questions related to lubrication, 3 questions related to orgasm, 3 questions related to satisfaction, and 3 questions related to pain. Subscale scores range from 1.2 to 6 (desire) or 0 to 6 (arousal, lubrication, orgasm, and pain) or 0.8 to 6 (satisfaction). A total FSFI score is computed as the sum of the individual subscales; the overall score ranges from 2 to 36. Higher scores indicate better sexual function. The primary outcome comparison is at 12 weeks.

Recruitment status

COMPLETED

Study phase

Target enrollment

186 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I: ArginMax ArginMax® 3 pills twice daily ArginMax: Given orally	Arm II: Placebo Patients receive oral placebo 3 pills twice daily Placebo: Given orally
Overall Study STARTED	94	92
Overall Study COMPLETED	71	67
Overall Study NOT COMPLETED	23	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I: ArginMax ArginMax® 3 pills twice daily ArginMax: Given orally	Arm II: Placebo Patients receive oral placebo 3 pills twice daily Placebo: Given orally
Overall Study Physician Decision	1	1
Overall Study Withdrawal by Subject	8	7
Overall Study Lost to Follow-up	6	7
Overall Study Surgery	1	2
Overall Study Toxicity	4	5
Overall Study Progression	1	0
Overall Study Multiple Reasons	2	3

Baseline Characteristics

L-Arginine Supplements in Treating Women Who Are Cancer Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I: ArginMax n=94 Participants ArginMax® 3 pills twice daily ArginMax: Given orally	Arm II: Placebo n=92 Participants Patients receive oral placebo 3 pills twice daily Placebo: Given orally	Total n=186 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=5 Participants	83 Participants n=7 Participants	169 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	51 years n=5 Participants	49 years n=7 Participants	50 years n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	92 Participants n=7 Participants	186 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	92 Participants n=5 Participants	84 Participants n=7 Participants	176 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) White	73 Participants n=5 Participants	73 Participants n=7 Participants	146 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	94 participants n=5 Participants	92 participants n=7 Participants	186 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Participants who filled out the FSFI at any time

Outcome measures

Outcome measures
Measure	Arm I: ArginMax n=93 Participants ArginMax® 3 pills twice daily ArginMax: Given orally	Arm II: Placebo n=90 Participants Patients receive oral placebo 3 pills twice daily Placebo: Given orally
Sexual Function	17.81 units on a scale Standard Error 0.90	17.15 units on a scale Standard Error 0.91

SECONDARY outcome

Timeframe: 12 weeks

Population: Participants who filled out the FACT-G at any time

Patients filled out the FACT-G quality of life questionnaire at baseline and at 4, 8, and 12 weeks following randomization. The FACT-G questionnaire is comprised of 7 questions related to physical well-being, 7 questions related to social well-being, 6 questions related to emotional well-being, and 7 questions related to functional well-being. Subscale scores range from 0 to 24 (Emotional) or 0 to 28 (Functional, Social, and Physical). A total FACT-G score is computed as the sum of the individual subscales; the overall score ranges from 0 to 108. Higher scores indicate better quality of life. The primary comparison was at 12 weeks.

Outcome measures

Outcome measures
Measure	Arm I: ArginMax n=93 Participants ArginMax® 3 pills twice daily ArginMax: Given orally	Arm II: Placebo n=92 Participants Patients receive oral placebo 3 pills twice daily Placebo: Given orally
Quality of Life	89.96 units on a scale Standard Error 1.38	85.47 units on a scale Standard Error 1.39

Adverse Events

Arm I: ArginMax

Serious events: 6 serious events

Other events: 64 other events

Deaths: 0 deaths

Arm II: Placebo

Serious events: 4 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I: ArginMax n=79 participants at risk ArginMax® 3 pills twice daily ArginMax: Given orally	Arm II: Placebo n=77 participants at risk Patients receive oral placebo 3 pills twice daily Placebo: Given orally
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/79 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.	1.3% 1/77 • Number of events 1 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.
Nervous system disorders Headache	1.3% 1/79 • Number of events 1 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.	0.00% 0/77 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.
General disorders Hot Flashes	3.8% 3/79 • Number of events 6 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.	3.9% 3/77 • Number of events 4 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.
Infections and infestations Infection - Vulva	1.3% 1/79 • Number of events 1 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.	0.00% 0/77 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.
Psychiatric disorders Insomnia	1.3% 1/79 • Number of events 1 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.	0.00% 0/77 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.
Gastrointestinal disorders Pain - Abdomen	1.3% 1/79 • Number of events 1 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.	0.00% 0/77 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.

Other adverse events

Other adverse events
Measure	Arm I: ArginMax n=79 participants at risk ArginMax® 3 pills twice daily ArginMax: Given orally	Arm II: Placebo n=77 participants at risk Patients receive oral placebo 3 pills twice daily Placebo: Given orally
General disorders Headache	25.3% 20/79 • Number of events 28 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.	32.5% 25/77 • Number of events 46 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.
General disorders Hot Flashes	70.9% 56/79 • Number of events 128 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.	55.8% 43/77 • Number of events 107 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.
Gastrointestinal disorders Nausea	6.3% 5/79 • Number of events 6 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.	10.4% 8/77 • Number of events 11 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.
Nervous system disorders Neuropathy	24.1% 19/79 • Number of events 38 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.	14.3% 11/77 • Number of events 27 • 12 weeks The sample size for this section is the number of participants who had post-randomization toxicity data.

Additional Information

Dr. Doug Case

Wake Forest NCORP Research Base

Phone: (336) 716-1048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place