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Colorectal CancerPhase 3POLAR-MNCT03654729

Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M)

A Phase 3 study testing Calmangafodipir (2 µmol/kg) and Calmangafodipir (5 µmol/kg) in people with Colorectal Cancer and Chemotherapy-induced Peripheral Neuropathy, run by Egetis Therapeutics AB (publ) at 98 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study evaluates the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Calmangafodipir (2 µmol/kg) and Calmangafodipir (5 µmol/kg)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
291 participants
Where
98 sitesin 13 countries
Study dates
7 Nov 2018to 31 Aug 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Signed informed consent form before any study related assessments and willing to follow all study procedures.
  • Male or female aged >=18 years.
  • Non-resectable metastatic (stage IV) CRC, pathologically confirmed adenocarcinoma of the colon or rectum.
  • No prior chemotherapy (within the previous 12 months) and/or biologic/targeted therapy for mCRC.
  • Measurable disease according to RECIST 1.1.
  • Patient indicated for at least 3 months of oxaliplatin-based chemotherapy (without any pre-planned treatment breaks) and without any clinically observed neurological disorders.
Show all 14Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate hematological parameters: hemoglobin >=100 g/L, absolute neutrophil count (ANC) >=1.5 x 10^9 /L, platelets >=100 x 10^9 /L.
  • Adequate renal function: creatinine clearance >50 cc/min using the Cockroft and Gault formula or measured.
  • Adequate hepatic function: total bilirubin <=1.5 times the upper limit of normal (ULN) (except in the case of known Gilbert's syndrome); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=3 times ULN (AST and ALT <=5 times ULN in case of liver metastases).
  • Baseline blood manganese (Mn) level <2.0 times ULN.
  • For patients with a history of diabetes mellitus, HbA1c <=7%.
  • Negative pregnancy test for females of child-bearing potential.
  • For men and females of childbearing potential, use of adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) while on study drug and for at least 6 months after completion of study therapy.

Who cannot join

  • Any unresolved toxicity by Common Terminology Criteria for Adverse Events Version (CTCAE v4.03) > Grade 1 from previous anti-cancer therapy (including radiotherapy), except alopecia.
  • Any grade of neuropathy from any cause.
  • Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, unresolved bowel obstruction, hepatic or renal disease).
  • Chronic infection or uncontrolled serious illness causing immunodeficiency.
  • Any history of seizures.
  • A surgical incision that is not healed.
Show all 19Show fewer
  • Significant hemorrhage (>30 mL/bleeding episode in previous 3 months), hemoptysis (>5 mL fresh blood in previous 4 weeks) or thrombotic event (including transient ischemic attack) in the previous 12 months if the patient is expected to receive anti-VEGF/VEGFR therapy.
  • Known hypersensitivity to any of the components of mFOLFOX6 and, if applicable, biological therapies to be used in conjunction with the chemotherapy regimen or any of the excipients of these products.
  • History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for that other malignancy for at least 2 years.
  • Known dihydropyrimidine dehydrogenase deficiency.
  • Pre-existing neurodegenerative disease (e.g., Parkinson's, Alzheimer's, Huntington's) or neuromuscular disorder (e.g., multiple sclerosis, amyotrophic lateral sclerosis, polio, hereditary neuromuscular disease).
  • Major psychiatric disorder (major depression, psychosis), alcohol and/or drug abuse.
  • Patients with a history of second or third degree atrioventricular block or a family heredity.
  • A history of a genetic or familial neuropathy.
  • Treatment with any investigational drug within 30 days prior to randomization.
  • Pregnancy, lactation or reluctance to using contraception.
  • Any other condition that, in the opinion of the Investigator, places the patient at undue risk.
  • Previous exposure to mangafodipir or calmangafodipir.
  • Welders, mine workers or other workers in occupations (current or past) where high manganese exposure is likely.

Trial locations and contacts

98 sites in 13 countries.

98 sites in 13 countries

France12 sites

  • CHRU de Brest - Hôpital Morvan

    Brest

  • Clinique Pasteur-Lanroze

    Brest

  • Centre Hospitalier Départemental de Vendée - Unité de recherche clinique

    La Roche-sur-Yon

  • Centre Oscar Lambret

    Lille

  • Hôpital Edouard Herriot - HCL

    Lyon

  • Hôpital Nord Franche-Comté Site du Mittan

    Montbéliard

  • Institut de Cancérologie de l'Ouest

    Nantes

  • Hopital l'Archet, CHU de Nice

    Nice

  • Hôpital Robert Debré

    Reims

  • Centre Hospitalier Privé Saint-Grégoire

    Saint-Grégoire

  • Clinique Ste Anne

    Strasbourg

  • Hopitaux Universitaires de Strasbourg

    Strasbourg

Other trials in France

Italy12 sites

  • IRCCS Candiolo

    Candiolo

  • Oncologia Istituti Ospitalieri

    Cremona

  • Irccs Irst

    Meldola - FC

  • Azienda Ospedaliero - Universitaria di Modena Policlinico

    Modena

  • Hospital San Gerardo

    Monza

  • Istituto Nazionale Tumori

    Naples

  • IRCCS Policlinico San Matteo

    Pavia

  • Ospedale degli infermi

    Ponderano

  • Ospedale S. Maria delle Croci - Ravenna

    Ravenna

  • IRCCS azienda Ospedaliera S Maria Nuova

    Reggio Emilia

  • San Camillo Forlanini Hospital

    Rome

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo

Other trials in Italy

Japan12 sites

  • Fujita Health University Hospital

    Aichi, 470-1192

  • Kyushu University Hospital

    Fukuoka-shi, Fukuoka, 812-8582

  • Fukuoka University Hospital

    Fukuoka-shi, Fukuoka, 814-0133

  • Kansai Rosai Hospital

    Hyōgo

  • St. Marianna University School of Medicine Hospital

    Kanagawa, 216-8511

  • Aichi Cancer Center Hospital

    Nagoya-shi, Aichi, 464-8681

  • Osaka University Hospital

    Osaka, 565-0871

  • Osaka International Cancer Institute

    Osaka-shi, Osaka, Osaka, 541-8567

  • National Hospital Organization Osaka National Hospital

    Osaka-shi, Osaka, 540-0006

  • Sapporo Medical University Hospital

    Sapporo-shi, Hokkaido, 065-0033

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • The Cancer Institute Hospital Of JFCR

    Tokyo, 135-8550

Other trials in Japan

United States11 sites

  • Hunterdon Hematology Oncology

    Flemington, New Jersey, 08822

  • California Cancer Associates

    Fresno, California, 93720

  • CHI St Francis Cancer Treatment Center

    Grand Island, Nebraska, 68803

  • Monter Cancer Center

    Lake Success, New York, 11042

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763

  • Willis-Knighton Cancer Center

    Shreveport, Louisiana, 71103

  • Mercy Clinic - Cancer & Hematology

    Springfield, Missouri, 65804

  • Mercy Clinic Oncology and Hematology

    St Louis, Missouri, 63141

  • Scott & White Vasicek Cancer Treatment Center

    Temple, Texas, 76508

  • Montefiore Medical Research

    The Bronx, New York, 10461

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

Spain11 sites

  • Hospital de La Santa Creu I Sant Pau

    Barcelona

  • L´Hospitalet de Llobregat (Barcelona)

    Barcelona

  • Vall d'hebron university hospital

    Barcelona

  • Complejo Hospitalario de Jaén

    Jaén

  • Centro Integral Oncologico Clara Campal

    Madrid

  • H.G.U.Gregorio Marañón

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Puerta de Hierro

    Majadahonda

  • Hospital Universitario Virgen Macarena

    Seville

  • Hospital Quironsalud Valencia

    Valencia

  • Hospital Miguel Servet

    Zaragoza

Other trials in Spain

Belgium8 sites

  • Onze-Lieve-Vrouwziekenuis Aalst

    Aalst

  • Imelda GI Clinical Research Center

    Bonheiden

  • Cliniques Universitaires St-Luc

    Brussels

  • UZ Gent

    Ghent

  • CHU Liège

    Liège

  • AZ Sint Maarten

    Mechelen

  • AZ Delta

    Roeselare

  • CHU UCL Namur - Site Godinne

    Yvoir

Other trials in Belgium

Czechia6 sites

  • Nemocnice Benesov

    Benešov

  • Nemocnice Horovice

    Hořovice

  • Nemocnice Na Pleši

    Nová Ves pod Pleší

  • General University Hospital

    Prague

  • Hospital Na Bulovce

    Prague

  • Onkologická Klinika 1. Lf Uk A Tn

    Prague

Other trials in Czechia

Germany6 sites

  • Hämatolgisch-onkologische Praxis Augsburg

    Augsburg

  • Onkozentrum Dresden

    Dresden

  • Universitätsklinikum Carl Gustav Carus

    Dresden

  • Agaplesion Markus Krankenhaus

    Frankfurt

  • Onkodok GmbH

    Gütersloh

  • Klinikum Neuperlach

    München

Other trials in Germany

South Korea6 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si

  • Dong-A University Hospital

    Busan

  • Chonnam National University Hwasun Hospital

    Gwangju

  • Seoul National University Bundang Hospital

    Seongnam-si

  • Korea University Guro Hospital

    Seoul

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

Hungary5 sites

  • Országos Onkológiai Intézet

    Budapest

  • Semmelweis Egyetem

    Budapest

  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

    Miskolc

  • Tolna Megyei Balassa Janos Korhaz

    Szekszárd

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet

    Szolnok

Other trials in Hungary

United Kingdom5 sites

  • Royal Marsden Hospital

    London, SW3 6JJ

  • North Tyneside General Hospital

    North Shields, NE29 8NH

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN

  • The Royal Marsden Hospital (Surrey)

    Sutton, SM2 5PT

  • York Teaching Hospital

    York, YO61 8HE

Other trials in United Kingdom

Taiwan3 sites

  • KMUH: Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • CMMC: Chi Mei Medical Center

    Tainan

  • NCKUH: National Cheng Kung University Hospital

    Tainan

Other trials in Taiwan

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Phase 3, Double-blind, Multicenter, Placebo-controlled Study of PledOx Used on Top of Modified FOLFOX6 (5-FU/FA and Oxaliplatin) to Prevent Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients With First-line mCRC

This study evaluates the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin.

Read the detailed description

Oxaliplatin, in combination with 5-fluorouracil plus folinate (or capecitabine), has increased survival in stage III colorectal cancer and prolonged life in stage IV patients, but its use is compromised because of severe toxicity. Chemotherapy-induced peripheral neuropathy (CIPN) is the most problematic dose-limiting toxicity of oxaliplatin. No treatments have been clinically proven to prevent CIPN. There is a body of evidence that CIPN is caused by cellular oxidative stress. Clinical and preclinical data suggest that the manganese chelate and superoxide dismutase mimetic mangafodipir (MnDPDP) and calmangafodipir ([Ca0.8,Mn0.2]Na3DPDP) are efficacious inhibitors of CIPN and other conditions caused by cellular oxidative stress, without interfering negatively with the tumoricidal activity of chemotherapy.

This is a Phase 3, multicenter, double-blind, placebo-controlled study to establish the efficacious dose of PledOx in prevention of chronic CIPN induced by oxaliplatin.

Patients with metastatic colorectal cancer (mCRC), who are indicated for first-line modified FOLFOX6 (mFOLFOX6) chemotherapy for at least 3 months, without any pre-planned treatment breaks, will be randomized in a 1:1:1 ratio, stratified by region (Asia, non-Asia) and PK sub-study (yes, no), to one of three treatment arms:

  • Arm A: PledOx (2 µmol/kg) + mFOLFOX6 chemotherapy
  • Arm B: PledOx (5 µmol/kg) + mFOLFOX6 chemotherapy
  • Arm C: Placebo + mFOLFOX6 chemotherapy

Before March 2nd., 2020, the Investigational Medicinal Product, (IMP; i.e. PledOx or placebo) was administered by an intravenous infusion on the first day of each chemotherapy (mFOLFOX6) cycle. IMP was not to be administered if mFOLFOX6 was not given to the patient.

If a patient later discontinues oxaliplatin, treatment with 5-FU/folinate may be continued.

The addition of an appropriate biologic therapy (bevacizumab, panitumumab, cetuximab) will be left to the discretion of the Investigator.

As of March 2nd., all patients have to stop IMP but may continue mFOLFOX 6

Being tested
Calmangafodipir (2 µmol/kg), Calmangafodipir (5 µmol/kg), Placebo
Keywords
Metastatic, Colorectal, Cancer, Metastatic Colorectal Cancer, Oxaliplatin induced CIPN, CIPN, Oxaliplatin
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calmangafodipir (2 µmol/kg)Drug

    Also called PledOx

    Solution in 20 mL single dose glass vials

  • Calmangafodipir (5 µmol/kg)Drug

    Also called PledOx

    Solution in 20 mL single dose glass vials

  • PlaceboDrug

    Solution in 20 mL single dose glass vials

Study groups in NCT03654729
Study groupRoleWhat they receive
PledOx (2 µmol/kg)ExperimentalCalmangafodipir (2 µmol/kg) on day 1 every two weeks to patients as an intravenous infusion, combined with mFOLFOX6 chemotherapy.
Receives: Drug: Calmangafodipir (2 µmol/kg)
PledOx (5 µmol/kg)ExperimentalCalmangafodipir (5 µmol/kg) on day 1 every two weeks to patients as an intravenous infusion, combined with mFOLFOX6 chemotherapy.
Receives: Drug: Calmangafodipir (5 µmol/kg)
PlaceboPlacebo comparatorPlacebo will be given to patients as an intravenous infusion, on top of mFOLFOX6 chemotherapy.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Moderate or Severe Chronic Chemotherapy Induced Peripheral Neuropathy (CIPN)

    Percentage of patients (with moderate or severe chronic CIPN) scoring 3 or 4 in at least 1 of the first 4 items of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-13-item subscale (FACT/GOG-NTX-13; i.e., FACT/GOG-NTX-4) 9 months after the first dose of IMP (i.e. PledOx or placebo administered on Day 1, Cycle 1 of mFOLFOX6 chemotherapy). The FACT/GOG-13 questionnaire includes 13 items that measure the severity and impact of symptoms of neurotoxicity over the past 7 days. Patients rate each item as 0 ("not at all"), 1 (" a little bit"), 2 ("somewhat"), 3 ("quite a bit") or 4 ("very much"). These 13 items are summed to create a total score, ranging from 0 to 52, with a higher score representing a worse outcome. The FACT/GOG-NTX-4 is a 4 item subscale targeting numbness, tingling or discomfort in hands and/or feet.

    Measured: 9 months

Secondary outcomes (9)

  1. Mild, Moderate or Severe Chronic Chemotherapy Induced Peripheral Neuropathy (CIPN)

    Percentage of patients (with mild, moderate or severe chronic CIPN) scoring 2, 3 or 4 in at least 1 of the first 4 items of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-13-item subscale (FACT/GOG-NTX-13; i.e., FACT/GOG-NTX-4) 9 months after the first dose of IMP (i.e. PledOx or placebo administered on Day 1, Cycle 1 of mFOLFOX6 chemotherapy). The FACT/GOG-13 questionnaire includes 13 items that measure the severity and impact of symptoms of neurotoxicity over the past 7 days. Patients rate each item as 0 ("not at all"), 1 (" a little bit"), 2 ("somewhat"), 3 ("quite a bit") or 4 ("very much"). These 13 items are summed to create a total score, ranging from 0 to 52, with a higher score representing a worse outcome. The FACT/GOG-NTX-4 is a 4 item subscale targeting numbness, tingling or discomfort in hands and/or feet.

    Measured: 9 months

  2. Sensitivity to Touching Cold Items

    Mean change from baseline in sensitivity to touching cold items on day 2, Cycle 4 of mFOLFOX6 chemotherapy, as assessed by the Cold Sensitivity Questionnaire (measuring sensitivity when touching or swallowing cold objects/fluid). 10 point scale from 0 meaning no sensitivity/discomfort at all to 10 meaning sensitivity/discomfort as bad as it can be.

    Measured: Baseline and 8 weeks

  3. Cumulative Dose of Oxaliplatin During Chemotherapy

    Mean cumulative dose of oxaliplatin administered per patient during mFOLFOX6 chemotherapy, 9 months after the first dose of IMP.

    Measured: 9 months

  4. Vibration Sensitivity on the Lateral Malleolus

    Mean change from baseline in vibration sense, on the lateral malleolus (left and right), using a graduated tuning fork, at 9 months after the first dose of IMP. When the tuning fork was struck against the ball of the thumb, the base of the tuning fork was placed over the appropriate bony surface (i.e., lateral malleolus left and right) and the patient was asked to indicate the moment when the vibration was no longer detected. The intensity at which the patient no longer detected the vibration is reported on a scale of 0 (minimum score, representing the maximum vibration amplitude) to 8 (maximum score, representing the minimum vibration amplitude)

    Measured: Baseline and 9 months

  5. Worst Pain in Hands or Feet

    Mean change from baseline in worst pain in hands or feet in the past week, using the Pain Assessment (Numerical Rating Scale (NRS)), at 9 months after the first dose of IMP. The NRS is a 10 point scale with 0 as no pain at all and 10 as pain as bad as you can imagine and evaluates the intensity of pain in hands and feet during the past week. A higher value means worse outcome.

    Measured: Baseline and 9 months

  6. Functional Impairment (in the Non-dominant Hand)

    Mean change from baseline in the time to complete the grooved Pegboard with the non-dominant hand, at 9 months after the first dose of IMP.

    Measured: Baseline and 9 months

  7. Overall Response Rate (ORR)

    Percentage of patients with an overall response (complete response or partial response) according to RECIST v1.1 for target lesions and assessed by CT (preferred) or MRI. Complete response=disappearance of all target lesions; partial response >=30% decrease in the sum of the longest diameter of target lesions.

    Measured: 12, 15 and 18 months

  8. Progression-free Survival (PFS)

    Patients with progression-free survival

    Measured: Analyses at 12 and 24 months were planned; the analysis was performed once based on available data at cut-off 31 August 2020 as the study was terminated early by the Sponsor

  9. Overall Survival (OS)

    Patients with overall survival

    Measured: An analysis at 36 months was planned. The analysis was performed based on available data at cut-off 31 August 2020 as the study was terminated early by the Sponsor

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2018
  2. Study start7 Nov 2018
  3. Primary completion31 Aug 2020
  4. Study completion31 Aug 2020

Why it stopped: On 23 January 2020, the Sponsor announced that the United States (US) Food and Drug Administration (FDA) had issued a clinical hold in the US of the POLAR program.

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a Phase 3, multicenter, double-blind, placebo-controlled study to establish the efficacious dose of PledOx in prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by oxaliplatin. Patients with metastatic colorectal cancer (mCRC), who are indicated for first-line modified FOLFOX6 (mFOLFOX6) chemotherapy for at least 3 months, without any pre-planned treatment breaks, will be randomized in a 1:1:1 ratio, stratified by region (Asia, non-Asia) and PK sub-study (yes, no) to one of three treatment arms: * Arm A: PledOx (2 µmol/kg) + mFOLFOX6 chemotherapy * Arm B: PledOx (5 µmol/kg) + m * Arm C: Placebo + mFOLFOX6 chemotherapy
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03654729
Sponsor's protocol ID
PP06490
Acronym
POLAR-M
Status last verified
Nov 2021
First submitted
29 Aug 2018
Last updated
17 Dec 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pfeiffer P, Lustberg M, Nasstrom J, Carlsson S, Persson A, Nagahama F, Cavaletti G, Glimelius B, Muro K. Calmangafodipir for Prevention of Oxaliplatin-Induced Peripheral Neuropathy: Two Placebo-Controlled, Randomized Phase 3 Studies (POLAR-A/POLAR-M). JNCI Cancer Spectr. 2022 Nov 1;6(6):pkac075. doi: 10.1093/jncics/pkac075.

    PubMed 36308441

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Calmangafodipir (2 µmol/kg) and Calmangafodipir (5 µmol/kg) in people with Colorectal Cancer and Chemotherapy-induced Peripheral Neuropathy, run by Egetis Therapeutics AB (publ) at 98 sites in 13 countries.

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 14 inclusion and 19 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: stopped early, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in France, Italy, Japan, United States, Spain and 8 more countries. 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. 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?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Moderate or Severe Chronic Chemotherapy Induced Peripheral Neuropathy (CIPN) (time frame: 9 months). 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 NCT03654729, which also lists 1 linked publication.

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 17 Dec 2021.

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