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Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients

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ClinicalTrials.gov Identifier: NCT01189409
Recruitment Status : Terminated (This study was terminated because of staffing issues and pending review.)
First Posted : August 26, 2010
Results First Posted : October 19, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Pippa Hawley, British Columbia Cancer Agency

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Constipation
Cancer
Interventions Drug: PEG then Senna
Drug: Senna then PEG
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PEG Then Senna Senna Then PEG
Hide Arm/Group Description

PEG in stepped bowel protocol

PEG then Senna: Stepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).

Stepped bowel protocol with Senna then PEG

Senna then PEG: Stepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).

Period Title: First 3 Weeks
Started 37 33
Completed 19 23
Not Completed 18 10
Period Title: Second 3 Weeks (Switch to 2nd Treatment)
Started 19 23
Completed 13 15
Not Completed 6 8
Arm/Group Title PEG Then Senna Senna Then PEG Total
Hide Arm/Group Description

PEG in stepped bowel protocol

PEG then Senna: Stepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).

Stepped bowel protocol with Senna then PEG

Senna then PEG: Stepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).

Total of all reporting groups
Overall Number of Baseline Participants 37 33 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 33 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  54.1%
22
  66.7%
42
  60.0%
>=65 years
17
  45.9%
11
  33.3%
28
  40.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants 33 participants 70 participants
72.8
(26 to 89)
59.2
(38 to 74)
66
(26 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 33 participants 70 participants
Female
23
  62.2%
15
  45.5%
38
  54.3%
Male
14
  37.8%
18
  54.5%
32
  45.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Lung Number Analyzed 37 participants 33 participants 70 participants
4
  10.8%
6
  18.2%
10
  14.3%
Breast Number Analyzed 37 participants 33 participants 70 participants
9
  24.3%
4
  12.1%
13
  18.6%
GI Number Analyzed 37 participants 33 participants 70 participants
3
   8.1%
3
   9.1%
6
   8.6%
Brain Number Analyzed 37 participants 33 participants 70 participants
1
   2.7%
0
   0.0%
1
   1.4%
Kidney Number Analyzed 37 participants 33 participants 70 participants
1
   2.7%
0
   0.0%
1
   1.4%
Prostate Number Analyzed 37 participants 33 participants 70 participants
3
   8.1%
3
   9.1%
6
   8.6%
Bladder Number Analyzed 37 participants 33 participants 70 participants
1
   2.7%
0
   0.0%
1
   1.4%
Haematological Number Analyzed 37 participants 33 participants 70 participants
3
   8.1%
5
  15.2%
8
  11.4%
Other Number Analyzed 37 participants 33 participants 70 participants
12
  32.4%
12
  36.4%
24
  34.3%
1.Primary Outcome
Title Bowel Performance Scale (BPS)
Hide Description Mean values of Number of Days with Satisfactory Bowel Movements Per Days of Treatment across time by treatment, derived from the mixed effects Poisson regression model. If the BPS rating on a day was -1, 0 or +1, the patient’s bowel movement on that day was deemed to be satisfactory.
Time Frame Last 18 days of each 21 day study period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polyethylene Glycol (PEG) Sennosides
Hide Arm/Group Description:
Those patients on PEG during either treatment period
Those patients on sennosides during either treatment period
Overall Number of Participants Analyzed 28 28
Mean (Full Range)
Unit of Measure: Ratio
Period 1
0.659
(0 to 0.941)
0.534
(0 to 1.0)
Period 2
0.641
(0.333 to 1.0)
0.636
(0.111 to 1.0)
2.Secondary Outcome
Title Patient Preference
Hide Description The patients will be asked to state which treatment period they prefer. Only assessed using patients who completed both arms of the study (n=28).
Time Frame end of study (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polyethylene Glycol (PEG) Senna No Preference
Hide Arm/Group Description:
Participants who completed both arms of the study and preferred PEG over Senna
Participants who completed both arms of the study and preferred Senna over PEG
Participants who completed both arms of the study and had no preference in treatment
Overall Number of Participants Analyzed 28 28 28
Measure Type: Count of Participants
Unit of Measure: Participants
13
  46.4%
13
  46.4%
2
   7.1%
3.Secondary Outcome
Title Time (in Days) to Attain an Ideal BPS Score of Goal
Hide Description

Proportion of patients in the study population estimated to reach a BPS at goal in the first period as a function of the time (in days) from day 1, presuming they were followed for 21 days and contributed a BPS score on each of those days.

Constipation was graded using the Victoria Bowel Performance Scale (BPS), a nine-point scale from -4 (constipation) to +4 (diarrhea) which has been validated for use in patients receiving palliative care.

Time Frame 3 weeks (ascertained at the end of period 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with a minimum of 7 days of treatment in the first period were included in the modeling.
Arm/Group Title Polyethylene Glycol (PEG) Senna
Hide Arm/Group Description:
Patients on the stepped bowel protocol with PEG accompanied by placebo alternate for the first 3 weeks.
Patients on the stepped bowel protocol with Senna accompanied by placebo alternate for the first 3 weeks.
Overall Number of Participants Analyzed 23 24
Median (95% Confidence Interval)
Unit of Measure: Days
6
(4 to 13)
8 [1] 
(6 to NA)
[1]
Only the lower bound could be computed
4.Secondary Outcome
Title Incidence of Cramps
Hide Description The patients were asked to indicate any experience of cramps while on study treatment
Time Frame Last 18 days of each 21 day study period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who reported incidence of cramps at least once.
Arm/Group Title Polyethylene Glycol (PEG) Senna
Hide Arm/Group Description:
Patients on PEG during either treatment period
Patients on Senna during either treatment period
Overall Number of Participants Analyzed 70 70
Measure Type: Count of Participants
Unit of Measure: Participants
27
  38.6%
25
  35.7%
5.Secondary Outcome
Title Rectal Measures
Hide Description The patients were asked to indicate any experience of rectal bleeding or rectal pain while on study treatment
Time Frame Last 18 days of each 21 day study period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who reported incidence of rectal pain or rectal bleeding at least once.
Arm/Group Title Polyethylene Glycol (PEG) Senna
Hide Arm/Group Description:
Patients on PEG during either treatment period
Patients on Senna during either treatment period
Overall Number of Participants Analyzed 70 70
Measure Type: Count of Participants
Unit of Measure: Participants
Rectal Bleeding
7
  10.0%
6
   8.6%
Rectal Pain
10
  14.3%
9
  12.9%
Time Frame 6 weeks (the end of the second treatment period)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Polyethylene Glycol (PEG) Senna
Hide Arm/Group Description Patients on PEG during either treatment period Patients on Senna during either treatment period
All-Cause Mortality
Polyethylene Glycol (PEG) Senna
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   1/70 (1.43%) 
Show Serious Adverse Events Hide Serious Adverse Events
Polyethylene Glycol (PEG) Senna
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/70 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Polyethylene Glycol (PEG) Senna
Affected / at Risk (%) Affected / at Risk (%)
Total   6/70 (8.57%)   7/70 (10.00%) 
Gastrointestinal disorders     
Diarrhea *  4/70 (5.71%)  2/70 (2.86%) 
Cramps *  0/70 (0.00%)  1/70 (1.43%) 
General disorders     
Dysphagia *  0/70 (0.00%)  1/70 (1.43%) 
Pain *  0/70 (0.00%)  1/70 (1.43%) 
Dizziness *  0/70 (0.00%)  1/70 (1.43%) 
 * [1]  1/70 (1.43%)  0/70 (0.00%) 
Product Issues     
Allergic Reaction * [2]  1/70 (1.43%)  0/70 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Shortness of Breath *  0/70 (0.00%)  1/70 (1.43%) 
*
Indicates events were collected by non-systematic assessment
[1]
Unable to determine patient adverse event - patient withdrew from study
[2]
Lactose intolerance to placebo
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Name/Title: Dr. Philippa Hawley
Organization: BC Cancer
Phone: 607-877-6000 ext 67-2707
Responsible Party: Pippa Hawley, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01189409     History of Changes
Other Study ID Numbers: H0901329
First Submitted: March 17, 2010
First Posted: August 26, 2010
Results First Submitted: September 25, 2018
Results First Posted: October 19, 2018
Last Update Posted: January 30, 2019