Colorectal CancerEarly Phase 1NCT02439580
Effect of Annona Muricata Leaves on Colorectal Cancer Patients and Colorectal Cancer Cells
A Early Phase 1 study testing Annona muricata extract in people with Colorectal Cancer, run by Universitas Indonesia.
Trial summary
Annona muricata L., include the leaves, is found to contain biologically active Annonaceous acetogenins and plant polyphenols that are important components of human diet and a number of them are considered to have chemopreventive and therapeutic properties against cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Annona muricata extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Oct 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Colorectal Carcinoma
- Have undergone standard therapy
- Satisfactory haematological or biochemical functions
- Karnofsky performance status of ≥ 60%
- Willing not to take probiotic supplement during study period
Who cannot join
- Uncontrolled hypertension
- Serious heart, kidney, liver endocrine or neurologic/psychiatric diseases
- Physical and mental disability that renders them unable to verbally communicate
- History of recent cancers
- Pregnant, lactating, or not using adequate contraception
- Patient on other investigational drug
About this study
Official title: Effect of Annona Muricata Leaves on Nutritional Status, Quality of Life, Fecal Butyrate, Inflammation, and Colorectal Cancer Cells
Annona muricata L., include the leaves, is found to contain biologically active Annonaceous acetogenins and plant polyphenols that are important components of human diet and a number of them are considered to have chemopreventive and therapeutic properties against cancer.
To confirm previous findings in in vitro, animal study and traditionally use, a human, ex vivo and in vitro studies were conducted to evaluate the effects of consecutive ingestion of A. muricata leaves extract for eight weeks.
Read the detailed description
Colorectal cancer patients were randomly assigned to receive either A. muricata leaves extract or placebo. Dietary intakes and anthropometry were assessed with food record every two weeks. Blood parameters, nutritional status, quality of life, fecal butyrate level, and systemic inflammation of patient were assessed at the beginning and the end of study.
- Conditions
- Colorectal Cancer
- Being tested
- Annona muricata extract, Placebo
- Keywords
- Patients, After Surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Annona muricata extractDietary supplement
ethanol-soluble fraction of water extract
PlaceboDietary supplement
maltose
| Study group | Role | What they receive |
|---|---|---|
| Annona muricata extract | Experimental | Annona muricata ethanol-soluble fraction of water extract capsule, 300 mg/day, for eight weeks Receives: Dietary Supplement: Annona muricata extract |
| Placebo | Placebo comparator | Maltose capsule, 300 mg/day, for eight weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional Status
Measured: eight weeks
Secondary outcomes (1)
Cytotoxicity
Cytotoxicity against colorectal cancer cell lines that were treated with serum of participants, is assessed by MTT assay
Measured: two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Indrawati, Universitas Indonesia
- Investigators
- Lili Indrawati, MSc, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439580
- Sponsor's protocol ID
- 406/H2.F1/ETIK/2013
- Status last verified
- May 2015
- First submitted
- 27 Apr 2015
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Annona Muricata Leaves on Nutritional Status, Quality of Life, Fecal Butyrate, Inflammation, and Colorectal Cancer Cells
- ClinicalTrials.gov ID
- NCT02439580
- Acronym / sponsor ID
- 406/H2.F1/ETIK/2013
- Conditions
- Colorectal Cancer
- Keywords
- Patients, After Surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Annona muricata L., include the leaves, is found to contain biologically active Annonaceous acetogenins and plant polyphenols that are important components of human diet and a number of them are considered to have chemopreventive and therapeutic properties against cancer.
To confirm previous findings in in vitro, animal study and traditionally use, a human, ex vivo and in vitro studies were conducted to evaluate the effects of consecutive ingestion of A. muricata leaves extract for eight weeks.
Detailed description
Colorectal cancer patients were randomly assigned to receive either A. muricata leaves extract or placebo. Dietary intakes and anthropometry were assessed with food record every two weeks. Blood parameters, nutritional status, quality of life, fecal butyrate level, and systemic inflammation of patient were assessed at the beginning and the end of study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Annona muricata extract | Experimental | Dietary Supplement: Annona muricata extractAnnona muricata ethanol-soluble fraction of water extract capsule, 300 mg/day, for eight weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltose capsule, 300 mg/day, for eight weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Colorectal Carcinoma
- Have undergone standard therapy
- Satisfactory haematological or biochemical functions
- Karnofsky performance status of ≥ 60%
- Willing not to take probiotic supplement during study period
Key exclusion criteria (6 listed)
- Uncontrolled hypertension
- Serious heart, kidney, liver endocrine or neurologic/psychiatric diseases
- Physical and mental disability that renders them unable to verbally communicate
- History of recent cancers
- Pregnant, lactating, or not using adequate contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Annona muricata extractethanol-soluble fraction of water extract | Dietary supplement | Annona muricata extract |
| Placebomaltose | Dietary supplement | Placebo |
Primary outcome
Nutritional Status
Time frame: eight weeks
1 secondary outcome
Cytotoxicity
Time frame: two days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lili Indrawati, MSc principal investigator
Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Annona muricata extract in people with Colorectal Cancer, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional Status (time frame: eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2015.