The chemopreventive effect of Lithium on adenoma development in patients with familial adenomatous polyposis (FAP); a pilot study

Phase 2

Recruiting

Conditions: familial adenomatous polyposis
familial intestinal polyps
10083624
10017990

Registration Number: NL-OMON51473

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

- Male or female between the age of 18 and 35 years;
- Confirmed APC germline mutation;
- Positive family history of a classical FAP phenotype (>100 colorectal
adenomas);
- Intact colon, with a minimum of 50 polyps;
- Participant is willing and able to give informed consent for participation

Exclusion Criteria

- Participation in any other clinical intervention study; observational trials
accepted;
- Lithium use prior to participation of the study;
- Pregnancy, breast-feeding or no use of anticonception;
- No normal intestinal mucosa left for normal tissue biopsy;
- Indication for colectomy within 2 years;
- Known renal impairment, defined as GFR < 60 ml/min;
- Known severe cardiac disorder;
- Known severe brain injury;
- Hypothyroidism;
- Hyponatremia, defined as Na < 130mmol/L;
- Positive family history of Brugada syndrome
- Co-medication known for interacting with Lithium (as defined in the protocol).
- Regular NSAID use (defined as more than twice a week for 4 consecutive weeks)
within 3 months prior to baseline;
- Use of immunosuppressive or anti-inflammatory drugs within 3 months prior to
baseline;
- Use of any other FAP directed drug therapy within 3 months prior to baseline
(use of any alternative supplements e.g. turmeric or fish-oil must be noted in
questionnaire).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Clone sizes will be quantified as proportions of the crypt circumference<br /><br>positive for NOTUM (in parts of eight, 1:8 to 8:8). When a whole crypt is<br /><br>positive for NOTUM (8:8), this crypt is fixed (crypt fixation).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Difference in number and size of polyps between baseline and end of study<br /><br>- Patient reported side effects of Lithium using a Lithium side effect<br /><br>questionnaire (see appendix 2 of the protocol)<br /><br>- Safety outcomes by analysing reported adverse events, physical examination<br /><br>and laboratory findings.</p><br>