Symptoms and General Pathology

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Constipation

Opioid-Induced Constipation

Signs and Symptoms, Digestive

Narcotic-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Gastrointestinal Agents

Herbal and Botanical

Analgesics, Opioid

Sennosides

Senna Extract

Laxatives

Cathartics

Senna

Stepped bowel protocol with Senna then PEG

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

PEG then Senna

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

Senna then PEG

Philippa Hawley, FRCPC

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.

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.

Double blind using a dummy alternate treatment.

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

A Randomized, Double Blind, Double-dummy, 2-treatment, 2-period Crossover Comparison of Sennosides and Polyethylene Glycol in Treatment of Opioid-induced Constipation in Outpatients With Cancer

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.

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).

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.

The patients were asked to indicate any experience of cramps while on study treatment

The patients were asked to indicate any experience of rectal bleeding or rectal pain while on study treatment

British Columbia Cancer Agency

Principal Investigator

Patients on PEG during either treatment period

Polyethylene Glycol (PEG)

Patients on Senna during either treatment period

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).

PEG Then Senna

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).

Senna Then PEG

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Lung

Breast

Brain

Kidney

Prostate

Bladder

Haematological

Other

Diagnosis

Dr. Philippa Hawley

Period 1

Period 2

Those patients on PEG during either treatment period

Those patients on sennosides during either treatment period

Bowel Performance Scale (BPS)

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

No Preference

Patient Preference

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.

Patients with a minimum of 7 days of treatment in the first period were included in the modeling.

Time (in Days) to Attain an Ideal BPS Score of Goal

Patients who reported incidence of cramps at least once.

Incidence of Cramps

Rectal Bleeding

Rectal Pain

Patients who reported incidence of rectal pain or rectal bleeding at least once.

Spots Global Cancer Trial Database for Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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