Trial Outcomes & Findings for Flaxseed in Treating Postmenopausal Women With Hot Flashes Who Have a History of Breast Cancer or Other Cancer or Who Do Not Wish to Take Estrogen Therapy (NCT NCT00956813)
NCT ID: NCT00956813
Last Updated: 2017-04-04
Results Overview
The intra-patient difference in hot flash activity between baseline (study week 1) and treatment termination (study week 7) is the primary endpoint. The hot flash activity will be measured by the weekly average hot flash score which is a composite entity of both frequency and severity of hot flashes. The hot flash severities are graded from 1 to 4, ranging from mild, to moderate, to severe to very severe. The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The average daily hot flash score during the baseline week was compared to the average daily value during week 7. The primary method of analysis will be the independent sample t-test to examine the change of weekly average hot flash score from baseline to treatment termination between flaxseed and placebo arms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
210 participants
Primary outcome timeframe
Baseline and 7 weeks
Results posted on
2017-04-04
Participant Flow
One-hundred-five patients were randomized to each of the Flaxseed arm and the Placebo arm. After unblinding, all patients had the option of continuing Flaxseed treatment for 6 additional weeks to obtain longer term information about the effects of flaxseed for the management of hot flashes and to allow the placebo arm to try the flaxseed.
Participant milestones
| Measure |
Flaxseed
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
|
Placebo
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
|
|---|---|---|
|
Flaxseed and Placebo
STARTED
|
105
|
105
|
|
Flaxseed and Placebo
COMPLETED
|
97
|
100
|
|
Flaxseed and Placebo
NOT COMPLETED
|
8
|
5
|
|
Continuation Phase
STARTED
|
80
|
0
|
|
Continuation Phase
COMPLETED
|
80
|
0
|
|
Continuation Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Flaxseed
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
|
Placebo
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
|
|---|---|---|
|
Flaxseed and Placebo
Withdrawal by Subject
|
5
|
4
|
|
Flaxseed and Placebo
Ineligible
|
3
|
1
|
Baseline Characteristics
Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
Baseline characteristics by cohort
| Measure |
Flaxseed
n=105 Participants
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
|
Placebo
n=105 Participants
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Flaxseed and Placebo Period · <50
|
25 Participants
n=105 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
24 Participants
n=105 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
49 Participants
n=210 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
|
Age, Customized
Flaxseed and Placebo Period · >=50
|
80 Participants
n=105 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
81 Participants
n=105 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
161 Participants
n=210 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
|
Age, Customized
Optional Flaxseed Continuation · <50
|
25 Participants
n=80 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
—
|
25 Participants
n=80 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
|
Age, Customized
Optional Flaxseed Continuation · >=50
|
55 Participants
n=80 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
—
|
55 Participants
n=80 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
|
Sex: Female, Male
Flaxseed and Placebo Period · Female
|
105 Participants
n=105 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
105 Participants
n=105 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
210 Participants
n=210 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
|
Sex: Female, Male
Flaxseed and Placebo Period · Male
|
0 Participants
n=105 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
0 Participants
n=105 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
0 Participants
n=210 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
|
Sex: Female, Male
Optional Flaxseed Continuation · Female
|
80 Participants
n=80 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
0 Participants
Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
80 Participants
n=80 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
|
Sex: Female, Male
Optional Flaxseed Continuation · Male
|
0 Participants
n=80 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
0 Participants
Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
0 Participants
n=80 Participants • Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
|
|
Region of Enrollment
United States
|
105 participants
n=105 Participants
|
105 participants
n=105 Participants
|
210 participants
n=210 Participants
|
PRIMARY outcome
Timeframe: Baseline and 7 weeksPopulation: Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)
The intra-patient difference in hot flash activity between baseline (study week 1) and treatment termination (study week 7) is the primary endpoint. The hot flash activity will be measured by the weekly average hot flash score which is a composite entity of both frequency and severity of hot flashes. The hot flash severities are graded from 1 to 4, ranging from mild, to moderate, to severe to very severe. The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The average daily hot flash score during the baseline week was compared to the average daily value during week 7. The primary method of analysis will be the independent sample t-test to examine the change of weekly average hot flash score from baseline to treatment termination between flaxseed and placebo arms.
Outcome measures
| Measure |
Flaxseed
n=69 Participants
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
|
Placebo
n=77 Participants
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
|
|---|---|---|
|
To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary.
|
-4.9 units on a scale
Standard Deviation 6.41
|
-3.5 units on a scale
Standard Deviation 6.47
|
SECONDARY outcome
Timeframe: Up to 7 weeksPopulation: All patients treated during the Double-blinded period of the study were included in this analysis
Frequency and severity of adverse events were reported by patients weekly evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
Outcome measures
| Measure |
Flaxseed
n=101 Participants
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
|
Placebo
n=102 Participants
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
|
|---|---|---|
|
Toxicity as Measured by CTCAE v3.0
Grade 3+ Adverse Event
|
0 Participants
|
1 Participants
|
|
Toxicity as Measured by CTCAE v3.0
Grade 4+ Adverse Event
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 7 weeksPopulation: Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)
Profile of Mood States (POMS) was used to look at total mood disturbance as well as the subscales of tension-anxiety, fatigue-inertia, and vigor-activity. The POMS is a well known, well validated, reliable measure of psychological distress which includes 6 subscales of fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment. The entire scale can be scored to provide a measure of total mood disturbance. The measure contains adjectives related to mood which are scored from 0 (not at all) to 4 (extremely). Individual scores were converted to a 0-100 scale where 100 is best quality of life. The change of mood as measured by the POMS from baseline to treatment termination between flaxseed versus placebo arms was compared using Kruskal-Wallis test. The mean change in total score for each arm is reported.
Outcome measures
| Measure |
Flaxseed
n=69 Participants
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
|
Placebo
n=77 Participants
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
|
|---|---|---|
|
Change of Mood as Measured by the Profile of Mood States (POMS)
|
6.6 units on a scale
Standard Deviation 9.92
|
5.7 units on a scale
Standard Deviation 9.41
|
SECONDARY outcome
Timeframe: Baseline and up to 7 weeksPopulation: Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)
The change in quality of life as measured by the MENQOL from baseline to treatment termination between flaxseed versus placebo arms was evaluated. On a 0-6 scale, patients were asked to answer questions in in each of 4 domain scores (Vasomotor, Psychosocial, Physical, Sexual) Scores were converted to a 0-100 scale where 100 is best QOL. The change in score from baseline to end of treatment were analyzed separately for each domain. Here we report the mean change in score for each category.
Outcome measures
| Measure |
Flaxseed
n=69 Participants
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
|
Placebo
n=77 Participants
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
|
|---|---|---|
|
Change of Menopause Specific Quality of Life as Measured by the Menopause Specific Quality of Life (MENQOL)
Change in Sexual Score
|
14.4 units on a scale
Standard Deviation 18.27
|
14.4 units on a scale
Standard Deviation 22.05
|
|
Change of Menopause Specific Quality of Life as Measured by the Menopause Specific Quality of Life (MENQOL)
Change in Vasomotor score
|
22.5 units on a scale
Standard Deviation 20.13
|
18.7 units on a scale
Standard Deviation 22.04
|
|
Change of Menopause Specific Quality of Life as Measured by the Menopause Specific Quality of Life (MENQOL)
Change in Psychosocial score
|
9.9 units on a scale
Standard Deviation 12.49
|
11.1 units on a scale
Standard Deviation 15.02
|
|
Change of Menopause Specific Quality of Life as Measured by the Menopause Specific Quality of Life (MENQOL)
Change in Physical Score
|
9.3 units on a scale
Standard Deviation 13.44
|
11.8 units on a scale
Standard Deviation 15.19
|
SECONDARY outcome
Timeframe: Baseline and up to 7 weeksPopulation: Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)
The change of daily interference as measured by the HFRDIS from baseline to treatment termination between flaxseed versus placebo arms was evaluated with an independent t-test for continuous data. On a 0-10 scale, patients were asked to describe how hot flashes interfered with 10 different aspects of their life (work, social activities, leisure activities, sleep, mood, concentration, relationships with others, sexuality, enjoyment of life and overall quality of life). Scores were converted to a 0-100 scale where 100 is best QOL.The HFRDIS total score was the average of the 10 individual questions. The change in total score from baseline to end of treatment was analyzed between the groups using a Kruskal-Wallace test.
Outcome measures
| Measure |
Flaxseed
n=69 Participants
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
|
Placebo
n=77 Participants
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
|
|---|---|---|
|
Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)
|
13.9 units on a scale
Standard Deviation 18.57
|
9.8 units on a scale
Standard Deviation 19.65
|
Adverse Events
Flaxseed
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 71 other events
Deaths: 0 deaths
Optional Continuation Period
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flaxseed
n=101 participants at risk
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
|
Placebo
n=102 participants at risk
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
|
Optional Continuation Period
n=76 participants at risk
After completing the Placebo/Flaxseed double-blind period, patients were allowed to continue with 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
32.7%
33/101 • Number of events 53 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
29.4%
30/102 • Number of events 50 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
14.5%
11/76 • Number of events 21 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
2/101 • Number of events 2 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
2.0%
2/102 • Number of events 2 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
1.3%
1/76 • Number of events 1 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Gastrointestinal disorders
Constipation
|
0.99%
1/101 • Number of events 2 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/102 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/76 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Gastrointestinal disorders
Diarrhea
|
10.9%
11/101 • Number of events 15 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
15.7%
16/102 • Number of events 19 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
7.9%
6/76 • Number of events 7 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Gastrointestinal disorders
Flatulence
|
44.6%
45/101 • Number of events 93 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
44.1%
45/102 • Number of events 79 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
35.5%
27/76 • Number of events 55 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Gastrointestinal disorders
Nausea
|
20.8%
21/101 • Number of events 29 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
15.7%
16/102 • Number of events 21 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
6.6%
5/76 • Number of events 8 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/101 • Number of events 3 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
5.9%
6/102 • Number of events 7 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
3.9%
3/76 • Number of events 4 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
General disorders
Fatigue
|
0.00%
0/101 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/102 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
1.3%
1/76 • Number of events 2 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Infections and infestations
Sinusitis
|
0.99%
1/101 • Number of events 1 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/102 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/76 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/101 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/102 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
1.3%
1/76 • Number of events 1 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/101 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.98%
1/102 • Number of events 1 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/76 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Nervous system disorders
Dizziness
|
0.00%
0/101 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/102 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
1.3%
1/76 • Number of events 1 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Nervous system disorders
Headache
|
0.99%
1/101 • Number of events 1 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/102 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/76 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.99%
1/101 • Number of events 1 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
8.8%
9/102 • Number of events 13 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
2.6%
2/76 • Number of events 4 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.0%
4/101 • Number of events 6 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
6.9%
7/102 • Number of events 13 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/76 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Vascular disorders
Hematoma
|
0.99%
1/101 • Number of events 1 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/102 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/76 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Vascular disorders
Hot flashes
|
0.00%
0/101 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.98%
1/102 • Number of events 1 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/76 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/101 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.98%
1/102 • Number of events 3 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
0.00%
0/76 • The Placebo and Flaxseed arm were the double-blinded first 7 weeks of treatment. After the 7 weeks of double-blinded treatment, patients were given the option of continuing treatment according to the Flaxseed arm for up to 6 additional weeks.
Adverse events were assessed every week during treatment. All patients that began study treatment and were assessed at least once for adverse events were included in this analysis
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60