The aim of the study is to compare magnesiumhydroxide and polyethylene glycol/electrolytes with regard to the prevention of constipation and side-effects in palliative care cancer patients starting with opioids.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
Degree of constipation as defined by the total score of the Patient Assessment
of Constipation-Symptom (PAC SYM;constipation symptom assessment instrument)
after 2 weeks of treatment.
The PAC SYM is an instrument to measure the degree and symptoms of constipation
during the previous week. It contains 12 items scored by the patient on a
5-point Likert scale. The scores can be calculated en give insight in 3
domains: symptoms of defaecation, rectal symptoms and abdominal symptoms. The
instrument has been validated for patients with chronic functional constipation
and for patients using opioids for chronic back pain. In the last study a Dutch
version has been used.
Secondary outcome
Secundary endpoints:
· Degree of contipation:
Totalscore PAC-SYM after 4, 6 and 8 weeks
Scores of subscales of the PAC-SYM after 2, 4, 6 and 8 weeks
Presence of Rome III criteria for constipation (2, 4, 6 and 8 weeks)
· Consequences of constipation for daily activities and functioning (2, 4, 6
and 8 weeks)
· Side-effects of laxatives(2, 4, 6 and 8 weeks)
· Patient preference (8 weeks)
Meetinstrumenten
. PAC-SYM (see above)
· Presence of Rome III criteria for constipation :
straining at least 25% of the time
incomplete evalcuation at least 25% of the time
feeling of rectal obstruction at least 25% of the time
necessity for manual manoeuvres to facilitatie defaecation at least
25% of the time
less than 3 bowel movements per week
Constipation is present if two or more criteria are met
· Consequences of constipation for daily activities and functioning (numeric
scale 0-10)
To what degree does constipation has influence on your daily life?
To whatr degree does constipation has influence on your quality of
life?
· Side effects of laxatives:
To what degree did you find taking laxatives easy (numeric scale
0-10)?
To what degree did you find the taste of the laxatives unpleasant
(numeric scale 0-10)?
Have you experienced side effects of the polyetylene
glycol/electrolytes or the magnesiumhydroxide? If so, which side-effects?
Patient preference (after using both laxatives): do you
prefer one of the laxatives over the other?
Background summary
Constipation occurs in 36-42% of palliative care cancer patients. Constipation
is the passage of hard faeces infrequently and with difficulty. The
consequences of constipation vary from discomfort for the patient to bowel
obstruction. Adequate prevention and treatment is essential. However, the
efficacy and side-effects of laxatives have been poorly studied and a choice,
based on scientific evidence cannot be made.
One of the most frequent causes of constipation in palliative care patients is
opioid use. Therefore, laxatives are routinely prescribed when starting
opioids. A Dutch national guideline on constipation recommends either
polyethylene glycol/electrolytes or magnesium hydroxide. A definite choice
between these two laxatives cannot be made because of lack of clinical studies.
Study objective
The aim of the study is to compare magnesiumhydroxide and polyethylene
glycol/electrolytes with regard to the prevention of constipation and
side-effects in palliative care cancer patients starting with opioids.
Study design
This is a randomized, open label study with cross-over
Patients are randomized between:
- 4 weeks of treatment with magnesiumhydroxide, followed by 4 weeks of
polyethylene glycol/electrolytes
- 4 weeks of polyethylene glycol/electrolytes followed by 4 weeks of treatment
with magnesiumhydroxide
Thus, the duration of the study is 8 weeks
Intervention
Interventions (cross-over after 4 weeks):
1. Magnesiumhydroxide (3dd 724 mg orally) or magnesiumoxide (3dd 500 mg orally)
during 4 weeks; if there is no effect (defined as 3 days without bowel
movements or passage of hard faeces during 3 days) the dose is doubled. If
there is no effect of the double dose add bisacody 5 mg a.n.
2. Polyethylene glycol/electrolytes 13.1 g orally; during 4 weeks; if tehre is
no effect (defined as 3 days without bowel movements or passage of hard faeces
during 3 days) the dose is doubled. If there is no effect of the double dose
add bisacody 5 mg a.n.
Study burden and risks
The patients use magnesiumhydroxide and polyethylene glycol/electrolytes each
for 4 weeks. Side effects may include bloating, flatulence, abdominal pain,
unpleasant taste, nausea, vomiting and diarrhoea. Patients using
magnesiumhydroxide are at risk for hypermagnesemia.
If the patients would be treated outside the study protocol, a laxative
(usually magnesiumhydroxide, polyethylene glycol/electrolytes or lactulose)
would also be prescribed.
The patients have to complete the questionnaires five times within 8 weeks. It
is estimated that this will take 20 minutes each time.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Palliative care cancer patients starting with opioids
Age >18 years
Exclusion criteria
Contra-indication for laxative use
Use of laxatives up to 4 weeks before entry in the study
Serum creatinine >180 ug/l
Estimated life expectancy <3 months
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-007610-10-NL |
| CCMO | NL24626.041.08 |