Chemotherapy EffectNCT04027478
Can Fasting Decrease the Side Effects of Chemotherapy?
A study testing FMD in people with Chemotherapy Effect and Chemotherapeutic Toxicity, run by Sutter Health at 1 site in United States.
Trial summary
This is a prospective randomized crossover trial. Patients will be randomized to the FMD or regular diet during three rounds of chemotherapy. After the third round, patients will cross over to the opposite arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Effect, Chemotherapeutic Toxicity, Fasting
- What is being tested?
- FMD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 1 Feb 2021
- 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
- 18 years of age and older
- English speaking
- Patients undergoing chemotherapy with Taxol/carboplatin planned for at least 6 cycles
- Willing to comply with diet and tests
- No significant medical problem that would make fasting dangerous (insulin dependent diabetes, history of hypoglycemia)
Who cannot join
- Insulin dependent diabetes
- Pregnancy
- History of hypoglycemia, or any other medical condition that the treating physician considers not suitable for fasting
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective randomized crossover trial. Patients will be randomized to the FMD or regular diet during three rounds of chemotherapy. After the third round, patients will cross over to the opposite arm. The primary hypothesis is that there will be fewer cases of Grade 2-4 nausea when patients are in the FMD sequence. The primary objective is to assess differences in toxicities in patients undergoing chemotherapy with a combination of taxol/carboplatin when using a fasting mimicking diet when compared to normal diet before and after treatment.
Read the detailed description
Randomization and blinding:
Subjects will be allocated to sequence 1 (normal diet first, FMD second) or sequence 2 (FMD first, normal diet second) using a computer generated randomization scheme. There will be no blinding
Intervention:
Over the course of three rounds of chemotherapy, patients in the FMD will consume a diet that consists of 10 cal/kg/day and includes 50% fat, 40% carbohydrates, and no more than 10% protein. The diet includes nuts, olives, vegetable broth, broccoli/cauliflower, white rice/puffed rice cake, onion, tea/coffee, almond milk. The diet prohibits meat products, dairy, alcohol, sugar, and artificial sweeteners. Patients will be instructed to drink 2 cups of water each morning, take their usual medications and limit exercise to walking.
The table below provides the schedule of fasting during the cycle of chemotherapy
(Time during chemotherapy cycle, Diet)
- 2 days prior to chemotherapy, Fasting mimicking diet
- 1 day prior to chemotherapy, Fasting mimicking diet
- Day of chemotherapy, Full fasting(water only)
- 1 day after chemotherapy, Fasting mimicking diet
- 2 days after chemotherapy, Fasting mimicking diet
Prior to each chemotherapy cycle and coincident FMD arm, weight, and laboratory testing will be conducted and patients will be asked to keep track of side effects as per usual care for patients undergoing chemotherapy. Patients will be asked to keep a food log and record the quality of their sleep as part of the study.
There will be no restrictions for use of usual standard medications, including anti-nausea medication. This is generally Zofran oral, q8 hours PRN. Anti-nausea medication usage will be recorded in the study database. Although it is expected to be consistent throughout the diet and control periods for each subject, dosage and frequency will be recorded throughout the study, and it will be noted if anti-nausea medication is effective during the control period for each subject.
Endpoint evaluation:
Severity of AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for toxicity and adverse event reporting. A copy of the CTCAE Version 3.0 can be downloaded from https://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf.
AEs not corresponding to the CTCAE term will be assessed according to their impact on the subject's ability to perform daily activities as follows:
Mild (grade 1) - the AE does not interfere in a significant manner with the subject's normal functioning level. It may be an annoyance.
- Moderate (grade 2) - the AE produces some impairment of functioning, but is not hazardous to health. It is uncomfortable or an embarrassment.
- Severe (grade 3) - the AE produces significant impairment of functioning or incapacitation and is a definite hazard to the subject's health.
- Life threatening (grade 4) - Life threatening or disabling.
- Fatal (grade 5) Causes death of the participant.
Estimated study duration:
Patient participation is approximately 16 weeks.
- Conditions
- Chemotherapy Effect, Chemotherapeutic Toxicity, Fasting
- Being tested
- FMD
- Keywords
- fasting, chemotherapy
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMDDietary supplement
fasting mimicking diet
| Study group | Role | What they receive |
|---|---|---|
| FMD (fasting-mimicking diet) | Active comparator | Over the course of three rounds of chemotherapy, patients in the FMD will consume a diet that consists of 10 cal/kg/day and includes 50% fat, 40% carbohydrates, and no more than 10% protein. The diet includes nuts, olives, vegetable broth, broccoli/cauliflower, white rice/puffed rice cake, onion, tea/coffee, almond milk. The diet prohibits meat products, dairy, alcohol, sugar, and artificial sweeteners. Patients will be instructed to drink 2 cups of water each morning, take their usual medications and limit exercise to walking. Receives: Dietary Supplement: FMD |
| regular diet | No intervention | Diet not influenced by a fast-mimicking diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea Grade
Grade 2-4 nausea when patients are in the FMD sequence versus the non-fasting sequence
Measured: 16 weeks
Secondary outcomes (3)
FMD Tolerability as measured by adverse events
Severity of AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for toxicity and adverse event reporting. AEs not corresponding to the CTCAE term will be assessed according to their impact on the subject's ability to perform daily activities as follows:
- Mild (grade 1) - the AE does not interfere in a significant manner with the subject's normal functioning level. It may be an annoyance.
- Moderate (grade 2) - the AE produces some impairment of functioning, but is not hazardous to health. It is uncomfortable or an embarrassment.
- Severe (grade 3) - the AE produces significant impairment of functioning or incapacitation and is a definite hazard to the subject's health.
- Life threatening (grade 4) - Life threatening or disabling.
- Fatal (grade 5) - Causes death of the participant.
Measured: 16 weeks
FMD Tolerability as measured by QOL Questionnaire
Mean differences in QOL between patients during the FMD versus normal diet sequence will be measured using a repeated measures analysis of variance. QOL questionnaire used will be the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire.
Measured: 16 weeks
Incidence of neutropenia
Differences in neutropenia between patients during the FMD versus normal diet sequence
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy EffectStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sutter Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacy D'Andre, MD, Sutter Health
- Investigators
- Stacy D'Andre, MD, Principal investigator, Sutter HealthCarol Parise, PhD, Study director, Sutter Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027478
- Sponsor's protocol ID
- SIMR_Onc18_IIS_D'Andre_Fasting
- Status last verified
- Jul 2019
- First submitted
- 26 Jun 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Di Biase S, Longo VD. Fasting-induced differential stress sensitization in cancer treatment. Mol Cell Oncol. 2015 Dec 10;3(3):e1117701. doi: 10.1080/23723556.2015.1117701. eCollection 2016 May.
PubMed 27314084Levine ME, Suarez JA, Brandhorst S, Balasubramanian P, Cheng CW, Madia F, Fontana L, Mirisola MG, Guevara-Aguirre J, Wan J, Passarino G, Kennedy BK, Wei M, Cohen P, Crimmins EM, Longo VD. Low protein intake is associated with a major reduction in IGF-1, cancer, and overall mortality in the 65 and younger but not older population. Cell Metab. 2014 Mar 4;19(3):407-17. doi: 10.1016/j.cmet.2014.02.006.
PubMed 24606898Lee C, Raffaghello L, Brandhorst S, Safdie FM, Bianchi G, Martin-Montalvo A, Pistoia V, Wei M, Hwang S, Merlino A, Emionite L, de Cabo R, Longo VD. Fasting cycles retard growth of tumors and sensitize a range of cancer cell types to chemotherapy. Sci Transl Med. 2012 Mar 7;4(124):124ra27. doi: 10.1126/scitranslmed.3003293. Epub 2012 Feb 8.
PubMed 22323820Mendelsohn AR, Larrick JW. Prolonged fasting/refeeding promotes hematopoietic stem cell regeneration and rejuvenation. Rejuvenation Res. 2014 Aug;17(4):385-9. doi: 10.1089/rej.2014.1595.
PubMed 25072352Safdie F, Brandhorst S, Wei M, Wang W, Lee C, Hwang S, Conti PS, Chen TC, Longo VD. Fasting enhances the response of glioma to chemo- and radiotherapy. PLoS One. 2012;7(9):e44603. doi: 10.1371/journal.pone.0044603. Epub 2012 Sep 11.
PubMed 22984531Raffaghello L, Safdie F, Bianchi G, Dorff T, Fontana L, Longo VD. Fasting and differential chemotherapy protection in patients. Cell Cycle. 2010 Nov 15;9(22):4474-6. doi: 10.4161/cc.9.22.13954. Epub 2010 Nov 15.
PubMed 21088487Brandhorst S, Longo VD. Fasting and Caloric Restriction in Cancer Prevention and Treatment. Recent Results Cancer Res. 2016;207:241-66. doi: 10.1007/978-3-319-42118-6_12.
PubMed 27557543Wei M, Brandhorst S, Shelehchi M, Mirzaei H, Cheng CW, Budniak J, Groshen S, Mack WJ, Guen E, Di Biase S, Cohen P, Morgan TE, Dorff T, Hong K, Michalsen A, Laviano A, Longo VD. Fasting-mimicking diet and markers/risk factors for aging, diabetes, cancer, and cardiovascular disease. Sci Transl Med. 2017 Feb 15;9(377):eaai8700. doi: 10.1126/scitranslmed.aai8700.
PubMed 28202779de Groot S, Vreeswijk MP, Welters MJ, Gravesteijn G, Boei JJ, Jochems A, Houtsma D, Putter H, van der Hoeven JJ, Nortier JW, Pijl H, Kroep JR. The effects of short-term fasting on tolerance to (neo) adjuvant chemotherapy in HER2-negative breast cancer patients: a randomized pilot study. BMC Cancer. 2015 Oct 5;15:652. doi: 10.1186/s12885-015-1663-5.
PubMed 26438237Vasey PA, Jayson GC, Gordon A, Gabra H, Coleman R, Atkinson R, Parkin D, Paul J, Hay A, Kaye SB; Scottish Gynaecological Cancer Trials Group. Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. J Natl Cancer Inst. 2004 Nov 17;96(22):1682-91. doi: 10.1093/jnci/djh323.
PubMed 15547181
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Fasting Decrease the Side Effects of Chemotherapy?
- ClinicalTrials.gov ID
- NCT04027478
- Acronym / sponsor ID
- SIMR_Onc18_IIS_D'Andre_Fasting
- Conditions
- Chemotherapy Effect, Chemotherapeutic Toxicity, Fasting
- Keywords
- fasting, chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Sutter HealthUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 22 Jul 2019 (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.
This is a prospective randomized crossover trial. Patients will be randomized to the FMD or regular diet during three rounds of chemotherapy. After the third round, patients will cross over to the opposite arm. The primary hypothesis is that there will be fewer cases of Grade 2-4 nausea when patients are in the FMD sequence. The primary objective is to assess differences in toxicities in patients undergoing chemotherapy with a combination of taxol/carboplatin when using a fasting mimicking diet when compared to normal diet before and after treatment.
Detailed description
Randomization and blinding:
Subjects will be allocated to sequence 1 (normal diet first, FMD second) or sequence 2 (FMD first, normal diet second) using a computer generated randomization scheme. There will be no blinding
Intervention:
Over the course of three rounds of chemotherapy, patients in the FMD will consume a diet that consists of 10 cal/kg/day and includes 50% fat, 40% carbohydrates, and no more than 10% protein. The diet includes nuts, olives, vegetable broth, broccoli/cauliflower, white rice/puffed rice cake, onion, tea/coffee, almond milk. The diet prohibits meat products, dairy, alcohol, sugar, and artificial sweeteners. Patients will be instructed to drink 2 cups of water each morning, take their usual medications and limit exercise to walking.
The table below provides the schedule of fasting during the cycle of chemotherapy
(Time during chemotherapy cycle, Diet)
- 2 days prior to chemotherapy, Fasting mimicking diet
- 1 day prior to chemotherapy, Fasting mimicking diet
- Day of chemotherapy, Full fasting(water only)
- 1 day after chemotherapy, Fasting mimicking diet
- 2 days after chemotherapy, Fasting mimicking diet
Prior to each chemotherapy cycle and coincident FMD arm, weight, and laboratory testing will be conducted and patients will be asked to keep track of side effects as per usual care for patients undergoing chemotherapy. Patients will be asked to keep a food log and record the quality of their sleep as part of the study.
There will be no restrictions for use of usual standard medications, including anti-nausea medication. This is generally Zofran oral, q8 hours PRN. Anti-nausea medication usage will be recorded in the study database. Although it is expected to be consistent throughout the diet and control periods for each subject, dosage and frequency will be recorded throughout the study, and it will be noted if anti-nausea medication is effective during the control period for each subject.
Endpoint evaluation:
Severity of AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for toxicity and adverse event reporting. A copy of the CTCAE Version 3.0 can be downloaded from https://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf.
AEs not corresponding to the CTCAE term will be assessed according to their impact on the subject's ability to perform daily activities as follows:
Mild (grade 1) - the AE does not interfere in a significant manner with the subject's normal functioning level. It may be an annoyance.
- Moderate (grade 2) - the AE produces some impairment of functioning, but is not hazardous to health. It is uncomfortable or an embarrassment.
- Severe (grade 3) - the AE produces significant impairment of functioning or incapacitation and is a definite hazard to the subject's health.
- Life threatening (grade 4) - Life threatening or disabling.
- Fatal (grade 5) Causes death of the participant.
Estimated study duration:
Patient participation is approximately 16 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMD (fasting-mimicking diet) | Active comparator | Dietary Supplement: FMDOver the course of three rounds of chemotherapy, patients in the FMD will consume a diet that consists of 10 cal/kg/day and includes 50% fat, 40% carbohydrates, and no more than 10% protein. The diet includes nuts, olives, vegetable broth, broccoli/cauliflower, white rice/puffed rice cake, onion, tea/coffee, almond milk. The diet prohibits meat products, dairy, alcohol, sugar, and artificial sweeteners. Patients will be instructed to drink 2 cups of water each morning, take their usual medications and limit exercise to walking. |
| regular diet | No intervention | –Diet not influenced by a fast-mimicking diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age and older
- English speaking
- Patients undergoing chemotherapy with Taxol/carboplatin planned for at least 6 cycles
- Willing to comply with diet and tests
- No significant medical problem that would make fasting dangerous (insulin dependent diabetes, history of hypoglycemia)
Key exclusion criteria (3 listed)
- Insulin dependent diabetes
- Pregnancy
- History of hypoglycemia, or any other medical condition that the treating physician considers not suitable for fasting
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 |
|---|---|---|
| FMDfasting mimicking diet | Dietary supplement | FMD (fasting-mimicking diet) |
Primary outcome
Nausea Grade
Time frame: 16 weeks
Grade 2-4 nausea when patients are in the FMD sequence versus the non-fasting sequence
3 secondary outcomes
FMD Tolerability as measured by adverse events
Time frame: 16 weeks
FMD Tolerability as measured by QOL Questionnaire
Time frame: 16 weeks
Incidence of neutropenia
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Background: PubMed 27314084Di Biase S, Longo VD. Fasting-induced differential stress sensitization in cancer treatment. Mol Cell Oncol. 2015 Dec 10;3(3):e1117701. doi: 10.1080/23723556.2015.1117701. eCollection 2016 May.
- Background: PubMed 24606898Levine ME, Suarez JA, Brandhorst S, Balasubramanian P, Cheng CW, Madia F, Fontana L, Mirisola MG, Guevara-Aguirre J, Wan J, Passarino G, Kennedy BK, Wei M, Cohen P, Crimmins EM, Longo VD. Low protein intake is associated with a major reduction in IGF-1, cancer, and overall mortality in the 65 and younger but not older population. Cell Metab. 2014 Mar 4;19(3):407-17. doi: 10.1016/j.cmet.2014.02.006.
- Background: PubMed 22323820Lee C, Raffaghello L, Brandhorst S, Safdie FM, Bianchi G, Martin-Montalvo A, Pistoia V, Wei M, Hwang S, Merlino A, Emionite L, de Cabo R, Longo VD. Fasting cycles retard growth of tumors and sensitize a range of cancer cell types to chemotherapy. Sci Transl Med. 2012 Mar 7;4(124):124ra27. doi: 10.1126/scitranslmed.3003293. Epub 2012 Feb 8.
- Background: PubMed 25072352Mendelsohn AR, Larrick JW. Prolonged fasting/refeeding promotes hematopoietic stem cell regeneration and rejuvenation. Rejuvenation Res. 2014 Aug;17(4):385-9. doi: 10.1089/rej.2014.1595.
- Background: PubMed 22984531Safdie F, Brandhorst S, Wei M, Wang W, Lee C, Hwang S, Conti PS, Chen TC, Longo VD. Fasting enhances the response of glioma to chemo- and radiotherapy. PLoS One. 2012;7(9):e44603. doi: 10.1371/journal.pone.0044603. Epub 2012 Sep 11.
- Background: PubMed 21088487Raffaghello L, Safdie F, Bianchi G, Dorff T, Fontana L, Longo VD. Fasting and differential chemotherapy protection in patients. Cell Cycle. 2010 Nov 15;9(22):4474-6. doi: 10.4161/cc.9.22.13954. Epub 2010 Nov 15.
- Background: PubMed 27557543Brandhorst S, Longo VD. Fasting and Caloric Restriction in Cancer Prevention and Treatment. Recent Results Cancer Res. 2016;207:241-66. doi: 10.1007/978-3-319-42118-6_12.
- Background: PubMed 28202779Wei M, Brandhorst S, Shelehchi M, Mirzaei H, Cheng CW, Budniak J, Groshen S, Mack WJ, Guen E, Di Biase S, Cohen P, Morgan TE, Dorff T, Hong K, Michalsen A, Laviano A, Longo VD. Fasting-mimicking diet and markers/risk factors for aging, diabetes, cancer, and cardiovascular disease. Sci Transl Med. 2017 Feb 15;9(377):eaai8700. doi: 10.1126/scitranslmed.aai8700.
- Background: PubMed 26438237de Groot S, Vreeswijk MP, Welters MJ, Gravesteijn G, Boei JJ, Jochems A, Houtsma D, Putter H, van der Hoeven JJ, Nortier JW, Pijl H, Kroep JR. The effects of short-term fasting on tolerance to (neo) adjuvant chemotherapy in HER2-negative breast cancer patients: a randomized pilot study. BMC Cancer. 2015 Oct 5;15:652. doi: 10.1186/s12885-015-1663-5.
- Background: PubMed 15547181Vasey PA, Jayson GC, Gordon A, Gabra H, Coleman R, Atkinson R, Parkin D, Paul J, Hay A, Kaye SB; Scottish Gynaecological Cancer Trials Group. Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. J Natl Cancer Inst. 2004 Nov 17;96(22):1682-91. doi: 10.1093/jnci/djh323.
- Dhand NK, Khatkar MS. Statulator: An online statistical calculator. Sample Size Calculator for Comparing Two Paired Proportions. 2014;Accessed 30 March 2018Link provided by the sponsor.
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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.
Stacy D'Andre, MD principal investigator
Sutter Health
Carol Parise, PhD study director
Sutter Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMD in people with Chemotherapy Effect and Chemotherapeutic Toxicity, run by Sutter Health at 1 site in United States.
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 3 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 22 Jul 2019. 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 United States. 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?
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?
Nausea Grade (time frame: 16 weeks). 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 NCT04027478, which also lists 10 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 22 Jul 2019.