Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00956813
Recruitment Status : Completed
First Posted : August 11, 2009
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Breast Cancer
Hot Flashes
Menopausal Symptoms
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Dietary Supplement: flaxseed
Other: placebo
Enrollment 210
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Flaxseed Placebo
Hide Arm/Group Description Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily. Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
Period Title: Flaxseed and Placebo
Started 105 105
Completed 97 100
Not Completed 8 5
Reason Not Completed
Withdrawal by Subject             5             4
Ineligible             3             1
Period Title: Continuation Phase
Started 80 0
Completed 80 0
Not Completed 0 0
Arm/Group Title Flaxseed Placebo Total
Hide Arm/Group Description Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily. Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily. Total of all reporting groups
Overall Number of Baseline Participants 105 105 210
Hide Baseline Analysis Population Description
All patients that registered are included in baseline characteristics for the Flaxseed and Placebo Period. Patients who continued treatment during the Optional Continuation Period were a subset of the original 210 patients and are reported separately.
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Flaxseed and Placebo Period Number Analyzed 105 participants 105 participants 210 participants
<50
25
  23.8%
24
  22.9%
49
  23.3%
>=50
80
  76.2%
81
  77.1%
161
  76.7%
Optional Flaxseed Continuation Number Analyzed 80 participants 0 participants 80 participants
<50
25
  31.3%
25
  31.3%
>=50
55
  68.8%
55
  68.8%
[1]
Measure Analysis Population Description: Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Flaxseed and Placebo Period Number Analyzed 105 participants 105 participants 210 participants
Female
105
 100.0%
105
 100.0%
210
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Optional Flaxseed Continuation Number Analyzed 80 participants 0 participants 80 participants
Female
80
 100.0%
0
80
 100.0%
Male
0
   0.0%
0
0
   0.0%
[1]
Measure Analysis Population Description: Patients that continued with the Optional Flaxseed Continuation Period were combined for baseline analysis.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 105 participants 105 participants 210 participants
105 105 210
1.Primary Outcome
Title To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary.
Hide Description

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.

Time Frame Baseline and 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Flaxseed Placebo
Hide Arm/Group Description:
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
Overall Number of Participants Analyzed 69 77
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.9  (6.41) -3.5  (6.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flaxseed, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Toxicity as Measured by CTCAE v3.0
Hide Description 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.
Time Frame Up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated during the Double-blinded period of the study were included in this analysis
Arm/Group Title Flaxseed Placebo
Hide Arm/Group Description:
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
Overall Number of Participants Analyzed 101 102
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 3+ Adverse Event
0
   0.0%
1
   1.0%
Grade 4+ Adverse Event
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Change of Mood as Measured by the Profile of Mood States (POMS)
Hide Description

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.

Time Frame Baseline and up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Flaxseed Placebo
Hide Arm/Group Description:
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
Overall Number of Participants Analyzed 69 77
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.6  (9.92) 5.7  (9.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flaxseed, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
4.Secondary Outcome
Title Change of Menopause Specific Quality of Life as Measured by the Menopause Specific Quality of Life (MENQOL)
Hide Description 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.
Time Frame Baseline and up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Flaxseed Placebo
Hide Arm/Group Description:
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
Overall Number of Participants Analyzed 69 77
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change in Vasomotor score 22.5  (20.13) 18.7  (22.04)
Change in Psychosocial score 9.9  (12.49) 11.1  (15.02)
Change in Physical Score 9.3  (13.44) 11.8  (15.19)
Change in Sexual Score 14.4  (18.27) 14.4  (22.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flaxseed, Placebo
Comments Testing the change in score from baseline to treatment completion for vasomotor-related questions in the MENQOL form.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Flaxseed, Placebo
Comments Testing the change in score from baseline to treatment completion for Psychosocial-related questions in the MENQOL form.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Flaxseed, Placebo
Comments Testing the change in score from baseline to treatment completion for Physical-related questions in the MENQOL form.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.238
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Flaxseed, Placebo
Comments Testing the change in score from baseline to treatment completion for Sexually-related questions in the MENQOL form.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.497
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
5.Secondary Outcome
Title Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)
Hide Description 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.
Time Frame Baseline and up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Flaxseed Placebo
Hide Arm/Group Description:
Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
Overall Number of Participants Analyzed 69 77
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.9  (18.57) 9.8  (19.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flaxseed, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame 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 Event Reporting Description 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
 
Arm/Group Title Flaxseed Placebo Optional Continuation Period
Hide Arm/Group Description Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily. Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily. 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.
All-Cause Mortality
Flaxseed Placebo Optional Continuation Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Flaxseed Placebo Optional Continuation Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/101 (0.00%)      0/102 (0.00%)      0/76 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Flaxseed Placebo Optional Continuation Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/101 (60.40%)      71/102 (69.61%)      32/76 (42.11%)    
Gastrointestinal disorders       
Abdominal distension  1  33/101 (32.67%)  53 30/102 (29.41%)  50 11/76 (14.47%)  21
Abdominal pain  1  2/101 (1.98%)  2 2/102 (1.96%)  2 1/76 (1.32%)  1
Constipation  1  1/101 (0.99%)  2 0/102 (0.00%)  0 0/76 (0.00%)  0
Diarrhea  1  11/101 (10.89%)  15 16/102 (15.69%)  19 6/76 (7.89%)  7
Flatulence  1  45/101 (44.55%)  93 45/102 (44.12%)  79 27/76 (35.53%)  55
Nausea  1  21/101 (20.79%)  29 16/102 (15.69%)  21 5/76 (6.58%)  8
Vomiting  1  2/101 (1.98%)  3 6/102 (5.88%)  7 3/76 (3.95%)  4
General disorders       
Fatigue  1  0/101 (0.00%)  0 0/102 (0.00%)  0 1/76 (1.32%)  2
Infections and infestations       
Sinusitis  1  1/101 (0.99%)  1 0/102 (0.00%)  0 0/76 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  1  0/101 (0.00%)  0 0/102 (0.00%)  0 1/76 (1.32%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/101 (0.00%)  0 1/102 (0.98%)  1 0/76 (0.00%)  0
Nervous system disorders       
Dizziness  1  0/101 (0.00%)  0 0/102 (0.00%)  0 1/76 (1.32%)  1
Headache  1  1/101 (0.99%)  1 0/102 (0.00%)  0 0/76 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pruritus  1  1/101 (0.99%)  1 9/102 (8.82%)  13 2/76 (2.63%)  4
Rash maculo-papular  1  4/101 (3.96%)  6 7/102 (6.86%)  13 0/76 (0.00%)  0
Vascular disorders       
Hematoma  1  1/101 (0.99%)  1 0/102 (0.00%)  0 0/76 (0.00%)  0
Hot flashes  1  0/101 (0.00%)  0 1/102 (0.98%)  1 0/76 (0.00%)  0
Vascular disorders - Other, specify  1  0/101 (0.00%)  0 1/102 (0.98%)  3 0/76 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Debra L. Barton, RN, PhD, AOCN
Organization: Mayo Clinic
EMail: barton.debra@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00956813    
Other Study ID Numbers: N08C7
NCCTG-N08C7
CDR0000644811 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-01928 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: August 8, 2009
First Posted: August 11, 2009
Results First Submitted: November 29, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017