Not provided
Not provided
Not provided
Not provided
Not provided
This study was terminated based on results of interim analysis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the British Columbia Cancer Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.
One group will be started on a bowel protocol of escalating doses of sennosides, plus a dummy polyethylene glycol (lactose), and the other will receive dummy sennosides capsules (lactose) plus polyethylene glycol, with the same dosing protocol. After three weeks of one active treatment the patients will switch to the alternate active product and dummy preparation. The total duration for the study will be 6 weeks for each patient.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG then Senna | Experimental | PEG in stepped bowel protocol |
|
| Senna then PEG | Experimental | Stepped bowel protocol with Senna then PEG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG then Senna | Drug | Stepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Performance Scale (BPS) | 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. | Last 18 days of each 21 day study period |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Preference | 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). | end of study (6 weeks) |
| Time (in Days) to Attain an Ideal BPS Score of Goal |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philippa Hawley, FRCPC | British Columbia Cancer Agency | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer Agency | Vancouver | British Columbia | V5Z 4E6 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PEG Then Senna | 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). |
| FG001 | Senna Then PEG | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 3 Weeks |
| |||||||||||||
| Second 3 Weeks (Switch to 2nd Treatment) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PEG Then Senna | 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). |
| BG001 | Senna Then PEG |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bowel Performance Scale (BPS) | 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. | Posted | Mean | Full Range | Ratio | Last 18 days of each 21 day study period |
|
6 weeks (the end of the second treatment period)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Polyethylene Glycol (PEG) | Patients on PEG during either treatment period | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philippa Hawley | BC Cancer | 607-877-6000 | 67-2707 | PHawley@bccancer.bc.ca |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2017 | Apr 9, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003248 | Constipation |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D020113 | Phenolphthalein |
| D000081226 | Sennosides |
| ID | Term |
|---|---|
| D010635 | Phenolphthaleins |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
The primary outcome will be treated as a binomial outcome, expressed as the number of successful trials out of a pre-defined number of trials n = 18. Given this, the primary outcome will be analysed via a generalized mixed effects model. The model will include: (i) fixed effects for treatment, treatment period and their interaction, (ii) fixed effects for the baseline characteristics and (iii) a random patient effect. Including the latter effect in the model will help capture the within-patient correlation among the values of the primary outcome collected in Period I and Period II for the same patient.
All statistical analyses will be conducted using the open-source statistical software package R.
Not provided
Not provided
Double blind using a dummy alternate treatment.
|
| Senna then PEG | Drug | Stepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder). |
|
|
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.
| 3 weeks (ascertained at the end of period 1) |
| Incidence of Cramps | The patients were asked to indicate any experience of cramps while on study treatment | Last 18 days of each 21 day study period |
| Rectal Measures | The patients were asked to indicate any experience of rectal bleeding or rectal pain while on study treatment | Last 18 days of each 21 day study period |
| NOT COMPLETED |
|
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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Patient Preference | 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). | Posted | Count of Participants | Participants | end of study (6 weeks) |
|
|
|
| Secondary | Time (in Days) to Attain an Ideal BPS Score of Goal | 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. | Patients with a minimum of 7 days of treatment in the first period were included in the modeling. | Posted | Median | 95% Confidence Interval | Days | 3 weeks (ascertained at the end of period 1) |
|
|
|
| Secondary | Incidence of Cramps | The patients were asked to indicate any experience of cramps while on study treatment | Patients who reported incidence of cramps at least once. | Posted | Count of Participants | Participants | Last 18 days of each 21 day study period |
|
|
|
| Secondary | Rectal Measures | The patients were asked to indicate any experience of rectal bleeding or rectal pain while on study treatment | Patients who reported incidence of rectal pain or rectal bleeding at least once. | Posted | Count of Participants | Participants | Last 18 days of each 21 day study period |
|
|
|
| 70 |
| 0 |
| 70 |
| 6 |
| 70 |
| EG001 | Senna | Patients on Senna during either treatment period | 1 | 70 | 0 | 70 | 7 | 70 |
| Dysphagia | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cramps | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
| Allergic Reaction | Product Issues | Non-systematic Assessment | Lactose intolerance to placebo |
|
| General disorders | Non-systematic Assessment | Unable to determine patient adverse event - patient withdrew from study |
|
Not provided
Not provided
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D012676 | Senna Extract |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |