Gastric AdenocarcinomaNCT04773769
Study of Guanábana Leaves for The Treatment of Patients With Gastric, Gastroesophageal Junction, Pancreatic and Colorectal Adenocarcinomas; Hepatocellular Carcinoma, and Low Grade Lymphomas
A study testing Tea Made of Graviola Leaves in people with Gastric Adenocarcinoma and Adenocarcinoma of the Gastroesophageal Junction, run by Auxilio Mutuo Cancer Center at 1 site in Puerto Rico.
Trial summary
Guanabana, known also as Graviola or Annona muricata is a tropical fruit which has been commonly used as complimentary/alternative medicine in Latin American countries. The main compounds in Graviola are the annonaceous acetogenins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Hepatocellular Carcinoma
- What is being tested?
- Tea Made of Graviola Leaves
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 7 Nov 2018to Nov 2023
- Phase
- Interventional
- 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
- Understand and voluntarily sign an informed consent form.
- Age > 18 years at the time of signing the informed consent form.
- Willing and able to adhere to the study visit schedule and other protocol requirements.
- Must have measurable or evaluable disease.
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 2 weeks prior to treatment in this study.
- Performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale at study entry.
Who cannot join
- Patients actively taking guanabana or guanabana tea daily or who have used it at some point after their diagnosis of cancer.
- Patients with Parkinson's disease.
- Serum Total Bilirubin ≥ 3.0 mg/dL
- Serum Creatinine level ≥ 3.0 mg/dL
- Central Nervous System (CNS) involvement.
- Known human immunodeficiency virus (HIV) infection; Known active hepatitis B or hepatitis C infection.
- Females who are pregnant (positive urine test) or breast-feeding females.
- Any history of a medical condition or a concomitant medical condition that, in the opinion of the investigator, would compromise the subject's ability to safely complete the study.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site, 1 recruiting
- Recruiting
Auxilio Mutuo Cancer Center
San Juan, 00918
Idalia Liboy, MD, 787-758-2000 ext. 3569, iliboy@auxiliomutuo.com
Fernando Cabanillas, MD
About this study
Official title: Pilot Phase 2 Study of Graviola (Guanabana) Leaves for The Treatment of Patients With Relapsed or Refractory Gastric Adenocarcinoma, Adenocarcinoma of Gastroesophageal Junction, Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, Low Grade Lymphomas and Colorectal Adenocarcinoma
Guanabana, known also as Graviola or Annona muricata is a tropical fruit which has been commonly used as complimentary/alternative medicine in Latin American countries. The main compounds in Graviola are the annonaceous acetogenins. These acetogenins have been shown to be selective and toxic against various types of cancer cells in-vitro and in-vivo experimental animal models. In spite of this evidence of anti tumor activity of Graviola, no prospective clinical studies have been carried out to determine if it also has clinical activity.The Investigator have observed two patients at Auxilio Mutuo Cancer Center who experienced significant tumor shrinkage while taking a tea made of Graviola leaves. Neither of these patients were taking any other treatment for their cancer. The investigator propose to conduct a study using guanabana leaves extract in patients with Gastroesophageal junction(GEJ) adenocarcinoma, as well as in Gastric adenocarcinoma, Hepatocellular carcinoma, Pancreatic adenocarcinoma, Low Grade Lymphomas and Colorectal adenocarcinoma.
Read the detailed description
Patients with relapsed/refractory gastric adenocarcinoma, adenocarcinoma of gastroesophageal junction, hepatocellular carcinoma, colorectal adenocarcinoma will be eligible. Colorectal adenocarcinomas will be eligible after failing second line therapy while the remainder will be eligible after first line therapy depending on the judgment of the treating oncologist. Any patient who refuse to receive chemotherapy will also be eligible even if they have not received chemotherapy. Patients with low grade lymphomas including chronic lymphocytic leukemias whose favorable blood counts and lack of symptoms make the candidates for "watch and wait" approach as well as any patient with low grade lymphoma who because of age or co-morbidity might not be eligible for chemotherapy or who refuse chemotherapy.
- Conditions
- Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, Low Grade Lymphoma, Colorectal Adenocarcinoma
- Being tested
- Tea Made of Graviola Leaves
- Medical subject headings
- Carcinoma, Hepatocellular, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tea Made of Graviola LeavesDietary supplement
Graviola leaves will be supplied to the patient with instructions on how to prepare the tea which will consist of 10 guanabana leaves which the patient will boil in 1 liter of water for 3 minutes. Once boiled, the formulation will be stores in the refrigerator and once cool enough the patient will start drinking 100 cc two times per day.
The Treatment Period begins with Cycle 1 Day 1 dosing. Patients will take the tea continuously during a 28-day cycles, until there is an indication for treatment change based on response assessment.
| Study group | Role | What they receive |
|---|---|---|
| Overall Statistical design | Experimental | We will treat 9 patients of each tumor type with a tea made of Graviola Leaves. If no responses are observed then the trial will be closed for that particular histological type. Should a response occur, then the trial will continue to the second stage for that cell type until 24 patients are accrued. If 3 or more responses are observed out of 24 cases, then the result will be considered promising. Receives: Dietary Supplement: Tea Made of Graviola Leaves |
What is being measured
The primary outcome is the main question the study is designed to answer.
RECIST criteria
RECIST criteria will be used to measure response in solid tumors.
Measured: Through study completion, an average of 3 years.
Cheson criteria
Cheson criteria will be used for lymphomas.
Measured: Through study completion, an average of 3 years.
Blood Counts
Cases with Chronic Lymphocytic Leukemia will have their Complete Blood Counts monitored and the Absolute lymphocyte count will be followed for response.
Measured: Through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start7 Nov 2018
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auxilio Mutuo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Cabanillas, Auxilio Mutuo Cancer Center
- Investigators
- Fernado Cabanillas, MD, Principal investigator, Hospital Español Auxilio Mutuo Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773769
- Sponsor's protocol ID
- CCAM 18-01
- Status last verified
- Feb 2021
- First submitted
- 4 Dec 2018
- Last updated
- 26 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chamcheu JC, Rady I, Chamcheu RN, Siddique AB, Bloch MB, Banang Mbeumi S, Babatunde AS, Uddin MB, Noubissi FK, Jurutka PW, Liu YY, Spiegelman VS, Whitfield GK, El Sayed KA. Graviola (Annona muricata) Exerts Anti-Proliferative, Anti-Clonogenic and Pro-Apoptotic Effects in Human Non-Melanoma Skin Cancer UW-BCC1 and A431 Cells In Vitro: Involvement of Hedgehog Signaling. Int J Mol Sci. 2018 Jun 16;19(6):1791. doi: 10.3390/ijms19061791.
PubMed 29914183Deep G, Kumar R, Jain AK, Dhar D, Panigrahi GK, Hussain A, Agarwal C, El-Elimat T, Sica VP, Oberlies NH, Agarwal R. Graviola inhibits hypoxia-induced NADPH oxidase activity in prostate cancer cells reducing their proliferation and clonogenicity. Sci Rep. 2016 Mar 16;6:23135. doi: 10.1038/srep23135.
PubMed 26979487Magadi VP, Ravi V, Arpitha A, Litha, Kumaraswamy K, Manjunath K. Evaluation of cytotoxicity of aqueous extract of Graviola leaves on squamous cell carcinoma cell-25 cell lines by 3-(4,5-dimethylthiazol-2-Yl) -2,5-diphenyltetrazolium bromide assay and determination of percentage of cell inhibition at G2M phase of cell cycle by flow cytometry: An in vitro study. Contemp Clin Dent. 2015 Oct-Dec;6(4):529-33. doi: 10.4103/0976-237X.169863.
PubMed 26681860Paul J, Gnanam R, Jayadeepa RM, Arul L. Anti cancer activity on Graviola, an exciting medicinal plant extract vs various cancer cell lines and a detailed computational study on its potent anti-cancerous leads. Curr Top Med Chem. 2013;13(14):1666-73. doi: 10.2174/15680266113139990117.
PubMed 23889049Sun S, Liu J, Kadouh H, Sun X, Zhou K. Three new anti-proliferative Annonaceous acetogenins with mono-tetrahydrofuran ring from graviola fruit (Annona muricata). Bioorg Med Chem Lett. 2014 Jun 15;24(12):2773-6. doi: 10.1016/j.bmcl.2014.03.099. Epub 2014 Apr 18.
PubMed 24780120Sun S, Liu J, Zhou N, Zhu W, Dou QP, Zhou K. Isolation of three new annonaceous acetogenins from Graviola fruit (Annona muricata) and their anti-proliferation on human prostate cancer cell PC-3. Bioorg Med Chem Lett. 2016 Sep 1;26(17):4382-5. doi: 10.1016/j.bmcl.2015.06.038. Epub 2015 Jun 25.
PubMed 27499453Yang C, Gundala SR, Mukkavilli R, Vangala S, Reid MD, Aneja R. Synergistic interactions among flavonoids and acetogenins in Graviola (Annona muricata) leaves confer protection against prostate cancer. Carcinogenesis. 2015 Jun;36(6):656-65. doi: 10.1093/carcin/bgv046. Epub 2015 Apr 11.
PubMed 25863125Torres MP, Rachagani S, Purohit V, Pandey P, Joshi S, Moore ED, Johansson SL, Singh PK, Ganti AK, Batra SK. Graviola: a novel promising natural-derived drug that inhibits tumorigenicity and metastasis of pancreatic cancer cells in vitro and in vivo through altering cell metabolism. Cancer Lett. 2012 Oct 1;323(1):29-40. doi: 10.1016/j.canlet.2012.03.031. Epub 2012 Apr 1.
PubMed 22475682Li Y, Ye J, Chen Z, Wen J, Li F, Su P, Lin Y, Hu B, Wu D, Ning L, Xue Q, Gu H, Ning Y. Annonaceous acetogenins mediated up-regulation of Notch2 exerts growth inhibition in human gastric cancer cells in vitro. Oncotarget. 2017 Mar 28;8(13):21140-21152. doi: 10.18632/oncotarget.15502.
PubMed 28416750Prabhakaran K, Ramasamy G, Doraisamy U, Mannu J, K R, Murugesan JR. Polyketide Natural Products, Acetogenins from Graviola (Annona muricata L), its Biochemical, Cytotoxic Activity and Various Analyses Through Computational and Bio-Programming Methods. Curr Pharm Des. 2016;22(34):5204-5210. doi: 10.2174/1381612822666160531163144.
PubMed 27262333Caparros-Lefebvre D, Elbaz A. Possible relation of atypical parkinsonism in the French West Indies with consumption of tropical plants: a case-control study. Caribbean Parkinsonism Study Group. Lancet. 1999 Jul 24;354(9175):281-6. doi: 10.1016/s0140-6736(98)10166-6.
PubMed 10440304Hollerhage M, Rosler TW, Berjas M, Luo R, Tran K, Richards KM, Sabaa-Srur AU, Maia JG, Moraes MR, Godoy HT, Hoglinger GU, Smith RE. Neurotoxicity of Dietary Supplements from Annonaceae Species. Int J Toxicol. 2015 Nov-Dec;34(6):543-50. doi: 10.1177/1091581815602252. Epub 2015 Sep 24.
PubMed 26405269Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
PubMed 2702835Lannuzel A, Hoglinger GU, Champy P, Michel PP, Hirsch EC, Ruberg M. Is atypical parkinsonism in the Caribbean caused by the consumption of Annonacae? J Neural Transm Suppl. 2006;(70):153-7. doi: 10.1007/978-3-211-45295-0_24.
PubMed 17017523Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.
PubMed 10655437
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Phase 2 Study of Graviola (Guanabana) Leaves for The Treatment of Patients With Relapsed or Refractory Gastric Adenocarcinoma, Adenocarcinoma of Gastroesophageal Junction, Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, Low Grade Lymphomas and Colorectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04773769
- Acronym / sponsor ID
- CCAM 18-01
- Conditions
- Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, Low Grade Lymphoma, Colorectal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Auxilio Mutuo Cancer CenterUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 26 Feb 2021 (actual)
- 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.
Guanabana, known also as Graviola or Annona muricata is a tropical fruit which has been commonly used as complimentary/alternative medicine in Latin American countries. The main compounds in Graviola are the annonaceous acetogenins. These acetogenins have been shown to be selective and toxic against various types of cancer cells in-vitro and in-vivo experimental animal models. In spite of this evidence of anti tumor activity of Graviola, no prospective clinical studies have been carried out to determine if it also has clinical activity.The Investigator have observed two patients at Auxilio Mutuo Cancer Center who experienced significant tumor shrinkage while taking a tea made of Graviola leaves. Neither of these patients were taking any other treatment for their cancer. The investigator propose to conduct a study using guanabana leaves extract in patients with Gastroesophageal junction(GEJ) adenocarcinoma, as well as in Gastric adenocarcinoma, Hepatocellular carcinoma, Pancreatic adenocarcinoma, Low Grade Lymphomas and Colorectal adenocarcinoma.
Detailed description
Patients with relapsed/refractory gastric adenocarcinoma, adenocarcinoma of gastroesophageal junction, hepatocellular carcinoma, colorectal adenocarcinoma will be eligible. Colorectal adenocarcinomas will be eligible after failing second line therapy while the remainder will be eligible after first line therapy depending on the judgment of the treating oncologist. Any patient who refuse to receive chemotherapy will also be eligible even if they have not received chemotherapy. Patients with low grade lymphomas including chronic lymphocytic leukemias whose favorable blood counts and lack of symptoms make the candidates for "watch and wait" approach as well as any patient with low grade lymphoma who because of age or co-morbidity might not be eligible for chemotherapy or who refuse chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall Statistical design | Experimental | Dietary Supplement: Tea Made of Graviola LeavesWe will treat 9 patients of each tumor type with a tea made of Graviola Leaves. If no responses are observed then the trial will be closed for that particular histological type. Should a response occur, then the trial will continue to the second stage for that cell type until 24 patients are accrued. If 3 or more responses are observed out of 24 cases, then the result will be considered promising. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Understand and voluntarily sign an informed consent form.
- Age > 18 years at the time of signing the informed consent form.
- Willing and able to adhere to the study visit schedule and other protocol requirements.
- Must have measurable or evaluable disease.
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 2 weeks prior to treatment in this study.
Key exclusion criteria (8 listed)
- Patients actively taking guanabana or guanabana tea daily or who have used it at some point after their diagnosis of cancer.
- Patients with Parkinson's disease.
- Serum Total Bilirubin ≥ 3.0 mg/dL
- Serum Creatinine level ≥ 3.0 mg/dL
- Central Nervous System (CNS) involvement.
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 |
|---|---|---|
| Tea Made of Graviola LeavesGraviola leaves will be supplied to the patient with instructions on how to prepare the tea which will consist of 10 guanabana leaves which the patient will boil in 1 liter of water for 3 minutes. Once boiled, the formulation will be stores in the refrigerator and once cool enough the patient will start drinking 100 cc two times per day. The Treatment Period begins with Cycle 1 Day 1 dosing. Patients will take the tea continuously during a 28-day cycles, until there is an indication for treatment change based on response assessment. | Dietary supplement | Overall Statistical design |
Primary outcome
RECIST criteria
Time frame: Through study completion, an average of 3 years.
RECIST criteria will be used to measure response in solid tumors.
Cheson criteria
Time frame: Through study completion, an average of 3 years.
Cheson criteria will be used for lymphomas.
Blood Counts
Time frame: Through study completion, an average of 3 years.
Cases with Chronic Lymphocytic Leukemia will have their Complete Blood Counts monitored and the Absolute lymphocyte count will be followed for response.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Background: PubMed 29914183Chamcheu JC, Rady I, Chamcheu RN, Siddique AB, Bloch MB, Banang Mbeumi S, Babatunde AS, Uddin MB, Noubissi FK, Jurutka PW, Liu YY, Spiegelman VS, Whitfield GK, El Sayed KA. Graviola (Annona muricata) Exerts Anti-Proliferative, Anti-Clonogenic and Pro-Apoptotic Effects in Human Non-Melanoma Skin Cancer UW-BCC1 and A431 Cells In Vitro: Involvement of Hedgehog Signaling. Int J Mol Sci. 2018 Jun 16;19(6):1791. doi: 10.3390/ijms19061791.
- Background: PubMed 26979487Deep G, Kumar R, Jain AK, Dhar D, Panigrahi GK, Hussain A, Agarwal C, El-Elimat T, Sica VP, Oberlies NH, Agarwal R. Graviola inhibits hypoxia-induced NADPH oxidase activity in prostate cancer cells reducing their proliferation and clonogenicity. Sci Rep. 2016 Mar 16;6:23135. doi: 10.1038/srep23135.
- Background: PubMed 26681860Magadi VP, Ravi V, Arpitha A, Litha, Kumaraswamy K, Manjunath K. Evaluation of cytotoxicity of aqueous extract of Graviola leaves on squamous cell carcinoma cell-25 cell lines by 3-(4,5-dimethylthiazol-2-Yl) -2,5-diphenyltetrazolium bromide assay and determination of percentage of cell inhibition at G2M phase of cell cycle by flow cytometry: An in vitro study. Contemp Clin Dent. 2015 Oct-Dec;6(4):529-33. doi: 10.4103/0976-237X.169863.
- Background: PubMed 23889049Paul J, Gnanam R, Jayadeepa RM, Arul L. Anti cancer activity on Graviola, an exciting medicinal plant extract vs various cancer cell lines and a detailed computational study on its potent anti-cancerous leads. Curr Top Med Chem. 2013;13(14):1666-73. doi: 10.2174/15680266113139990117.
- Background: PubMed 24780120Sun S, Liu J, Kadouh H, Sun X, Zhou K. Three new anti-proliferative Annonaceous acetogenins with mono-tetrahydrofuran ring from graviola fruit (Annona muricata). Bioorg Med Chem Lett. 2014 Jun 15;24(12):2773-6. doi: 10.1016/j.bmcl.2014.03.099. Epub 2014 Apr 18.
- Background: PubMed 27499453Sun S, Liu J, Zhou N, Zhu W, Dou QP, Zhou K. Isolation of three new annonaceous acetogenins from Graviola fruit (Annona muricata) and their anti-proliferation on human prostate cancer cell PC-3. Bioorg Med Chem Lett. 2016 Sep 1;26(17):4382-5. doi: 10.1016/j.bmcl.2015.06.038. Epub 2015 Jun 25.
- Background: PubMed 25863125Yang C, Gundala SR, Mukkavilli R, Vangala S, Reid MD, Aneja R. Synergistic interactions among flavonoids and acetogenins in Graviola (Annona muricata) leaves confer protection against prostate cancer. Carcinogenesis. 2015 Jun;36(6):656-65. doi: 10.1093/carcin/bgv046. Epub 2015 Apr 11.
- Background: PubMed 22475682Torres MP, Rachagani S, Purohit V, Pandey P, Joshi S, Moore ED, Johansson SL, Singh PK, Ganti AK, Batra SK. Graviola: a novel promising natural-derived drug that inhibits tumorigenicity and metastasis of pancreatic cancer cells in vitro and in vivo through altering cell metabolism. Cancer Lett. 2012 Oct 1;323(1):29-40. doi: 10.1016/j.canlet.2012.03.031. Epub 2012 Apr 1.
- Background: PubMed 28416750Li Y, Ye J, Chen Z, Wen J, Li F, Su P, Lin Y, Hu B, Wu D, Ning L, Xue Q, Gu H, Ning Y. Annonaceous acetogenins mediated up-regulation of Notch2 exerts growth inhibition in human gastric cancer cells in vitro. Oncotarget. 2017 Mar 28;8(13):21140-21152. doi: 10.18632/oncotarget.15502.
- Background: PubMed 27262333Prabhakaran K, Ramasamy G, Doraisamy U, Mannu J, K R, Murugesan JR. Polyketide Natural Products, Acetogenins from Graviola (Annona muricata L), its Biochemical, Cytotoxic Activity and Various Analyses Through Computational and Bio-Programming Methods. Curr Pharm Des. 2016;22(34):5204-5210. doi: 10.2174/1381612822666160531163144.
- Background: PubMed 10440304Caparros-Lefebvre D, Elbaz A. Possible relation of atypical parkinsonism in the French West Indies with consumption of tropical plants: a case-control study. Caribbean Parkinsonism Study Group. Lancet. 1999 Jul 24;354(9175):281-6. doi: 10.1016/s0140-6736(98)10166-6.
- Background: PubMed 26405269Hollerhage M, Rosler TW, Berjas M, Luo R, Tran K, Richards KM, Sabaa-Srur AU, Maia JG, Moraes MR, Godoy HT, Hoglinger GU, Smith RE. Neurotoxicity of Dietary Supplements from Annonaceae Species. Int J Toxicol. 2015 Nov-Dec;34(6):543-50. doi: 10.1177/1091581815602252. Epub 2015 Sep 24.
- Graviola: A Systematic Review on Its Anticancer PropertiesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Fernado Cabanillas, MD principal investigator
Hospital Español Auxilio Mutuo Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tea Made of Graviola Leaves in people with Gastric Adenocarcinoma and Adenocarcinoma of the Gastroesophageal Junction, run by Auxilio Mutuo Cancer Center at 1 site in Puerto Rico.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Cabanillas, MD (787-758-2000 ext. 3503, cabanillasmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RECIST criteria (time frame: Through study completion, an average of 3 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04773769, which also lists 15 linked publications.
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 26 Feb 2021.