Quality of Life (QOL)NCT06733545
Study for the Evaluation of the Degree of Skin Satisfaction of a Cosmetic Cream for Sensitive Skin in Oncological Patients Affected by a Palmoplantar Polyneuropathy Secondary to Chemotherapy.
An observational study of Quality of Life (QOL) and CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by PROSPERA BIOTECH S.L. at 1 site in Spain.
Trial summary
It is proposed a controlled research study aimed to evaluating and comparing the degree of skin satisfaction and comfort with cosmetic creams PB-011 and PB-012 in cancer patients who can develop a palmar and plantar peripheral polyneuropathy by treatment with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life (QOL), CIPN - Chemotherapy-Induced Peripheral Neuropathy
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2022to 16 Oct 2024
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- 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
Study population: The study population was anyone over 18 years of age who met the inclusion and exclusion criteria and who was about to start chemotherapy treatment.
Who may be able to join
- To be older than 18 year old
- To be able to complete questionnaires
- Give informed consent in writing
- Being able to apply the product under test by oneself
- To have been diagnosed with stage I-III primary cancer
- To have received a maximum of one treatment session with chemotherapy (derivatives of taxane, platinum or vincristines)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- Life expectancy greater than or equal to 6 months
Who cannot join
- Not being or having been treated with antidepressants, antiepileptics or HIV medication in the last 3 months
- Pre-existing peripheral neuropathies not related to chemotherapy treatment
- Pre-existing neurodegenerative or neuromuscular disease or history of stroke
- Family history of neuropathic diseases
- Having suffered in the last 6 months: myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization or class III/IV heart failure.
- Being receiving investigational treatment (being involved in a clinical trial
Show all 13Show fewer
- Evidence or indication of metastasis affecting the Central Nervous System
- Use of immunosuppressive or immunomodulatory medication that may lead to immunodeficiencies
- Not being treated with topical palmar and/or plantar medication
- Known hypersensitivity to capsaicin
- Having reduced capacity for expression or response to forms
- Not have been under general anesthesia for at least one month before starting the study
- Complication of peripheral polyneuropathy symptoms that require the use of specific medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study for the Evaluation of the Degree of Skin Satisfaction of Cosmetics Creams PB-011 and PB-012 for Sensitive Skin in Oncological Patients Affected by a Palmoplantar Polyneuropathy Secondary to Chemotherapy or Chemotherapeutic Agents' Fusion to Monoclonal Antibodies (Immunocitostatics)
It is proposed a controlled research study aimed to evaluating and comparing the degree of skin satisfaction and comfort with cosmetic creams PB-011 and PB-012 in cancer patients who can develop a palmar and plantar peripheral polyneuropathy by treatment with chemotherapy. Both products are cosmetic creams derived from the cosmetic Nocisens® line (for the care of sensitive skin with atopic tendency). The hypothesis that is proposed to test is that the care with PB-011 or PB-012 of the sensitive skin associated with palmar and plantar peripheral polyneuropathy of cancer patients will increase their degree of satisfaction and skin comfort. This study is proposed in patients who are going to start chemotherapeutic treatment. The study conceives two populations: (i) population where PB-011 cream will be tested; and (ii) population that will test PB-012 cream. A sample size of 60 volunteers per population has been estimated to ensure statistical significance. As a qualitative relevant variable for patients, the degree of satisfaction and skin comfort of the volunteers will be assessed by means of questionnaires.
Read the detailed description
This proof-of-concept clinical trial is a multicenter, double-blind, randomized, placebo-controlled research project approved by the ethics committees of all participating hospitals. Medical oncologists have been responsible for recruiting volunteers, checking that they meet the inclusion and exclusion criteria, obtaining signed informed consent, completing the data collection booklet and collecting the occurrence of CIPN and the degree of CIPN, along with patient follow-up. Once informed consent has been signed, the patients are provided with a PB-011 or the PB-012 formulation and started a daily application on their hands. After the onset of sensory symptoms on hands and/or feet, participants applied the cream twice daily on hands and feet and began responding questionnaires to evaluate the severity of sensorial symptoms.
- Keywords
- CIPN, Sensitive skin, Quality of life, Chemotherapy, Chemotherapy skin side effects, palmoplantar discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PB-011 | Patients starting chemotherapy treatment are given (double blinded) moisturizing cream PB-011 to use once a day in hands. If sensory discomfort appears in hands or feet, the dosage could be increased up to twice a day in hands and feet. | |
| PB-012 | Patients undergoing chemotherapy treatment are given (double blinded) moisturizing cream PB-012 to use once a day in hands. If sensory discomfort appears in hands or feet, the dosage could be increased up to twice a day in hands and feet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory discomfort appearance in hands and/or feet as a measure of quality of life
The appearance of sensory sensations resulting from CIPN will be detected by the oncologists' follow-up. The oncologists will indicate the treatment cycle in which the neuropathy discomfort appears and their degree in the data collection notebook. The study involves following the patient from the first cycle of chemotherapy until one month after the end of treatment.
Measured: The estimated period of time over which the event is assessed is up to16 weeks, which correspond from the first CT cycle (cycles are received once a week, 12 CT cycles) up to one month later.
Secondary outcomes (1)
Skin Discomfort Severity
Once recruited volunteers start experiencing sensory skin discomfort in hands/feet and inform their oncologist, a Leonard Scale questionnaire was used to monitor these symptoms (The Leonard Scale1 consists of 14 questions that quantify the subjective intensity of each symptom (e.g. itch, stinging, pain…). Intensity is rated from 1-10, being 1 hardly any and 10 very much).
- Leonard GD, Wright MA, Quinn MG, Fioravanti S, Harold N, Schuler B, Thomas RR, Grem JL. Survey of oxaliplatin-associated neurotoxicity using an interview-based questionnaire in patients with metastatic colorectal cancer. BMC Cancer. 2005 Sep 16;5:116. doi: 10.1186/1471-2407-5-116. PMID: 16168057; PMCID: PMC1266024.
Measured: Questionnaire was done every three weeks until one month after treatment was finished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start4 Apr 2022
- Primary completion24 Sep 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Quality of Life (QOL)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- PROSPERA BIOTECH S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital General Universitario Elche, Hospital Miguel Servet, Hospital del Mar, Hospital Marina Baixa, Alicante, Hospital Universitario Ramon y Cajal, Hospital General Universitario Santa Lucia, Hospital Universitari Sagrat Cor, Barcelona, Hospital General de Elda, Centre Hospitalier Universitaire Saint Pierre, Universidad Miguel Hernandez de Elche
- Responsible party
- Sponsor
- Investigators
- Antonio Sonia Servitja, Oncologist, Principal investigator, Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)Maria Castro-Henriques, Oncologist, Principal investigator, Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)Iñaki Álvarez-Busto, Oncologist, Principal investigator, Servicio de Oncología Médica, Hospital Universitario Miguel Servet, 50009 Zaragoza (Spain)Maria Asunción Algarra-García, Oncologist, Principal investigator, Servicio de Oncología Médica, Hospital Marina Baixa, 03570 Villajoyosa, Alicante (Spain)Elena López-Miranda, Oncologist, Principal investigator, Servicio de Oncología Médica, Hospital Universitario Ramon y Cajal, 28034 Madrid (Spain)Maria I Luengo-Alcázar, Oncologist, Principal investigator, Servicio de Oncología Médica, Hospital General Universitario Santa Lucía, 30202 Cartagena, Murcia (Spain)Miguel Borregón, Oncologist, Principal investigator, Servicio de Oncología Médica, Hospital General Universitario de Elche, 03202 Elche, Alicante (Spain)Anna Gassull-Delgado, Nursery, Principal investigator, Servicio de Oncología Médica, Hospital Universitari Sagrat Cor, 08029 Barcelona (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733545
- Sponsor's protocol ID
- 20-PB02
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data on the anonymised patients such as treatment, number of cycles, sex, age and morbidities during the study could be shared with reviwers or researchers.
Publications
Bae EH, Greenwald MK, Schwartz AG. Chemotherapy-Induced Peripheral Neuropathy: Mechanisms and Therapeutic Avenues. Neurotherapeutics. 2021 Oct;18(4):2384-2396. doi: 10.1007/s13311-021-01142-2. Epub 2021 Oct 21.
PubMed 34676514Chen X, Gan Y, Au NPB, Ma CHE. Current understanding of the molecular mechanisms of chemotherapy-induced peripheral neuropathy. Front Mol Neurosci. 2024 Apr 10;17:1345811. doi: 10.3389/fnmol.2024.1345811. eCollection 2024.
PubMed 38660386Aromolaran KA, Goldstein PA. Ion channels and neuronal hyperexcitability in chemotherapy-induced peripheral neuropathy; cause and effect? Mol Pain. 2017 Jan-Dec;13:1744806917714693. doi: 10.1177/1744806917714693.
PubMed 28580836Nikolaeva-Koleva M, Butron L, Gonzalez-Rodriguez S, Devesa I, Valente P, Serafini M, Genazzani AA, Pirali T, Ballester GF, Fernandez-Carvajal A, Ferrer-Montiel A. A capsaicinoid-based soft drug, AG1529, for attenuating TRPV1-mediated histaminergic and inflammatory sensory neuron excitability. Sci Rep. 2021 Jan 8;11(1):246. doi: 10.1038/s41598-020-80725-z.
PubMed 33420359Serafini M, Griglio A, Aprile S, Seiti F, Travelli C, Pattarino F, Grosa G, Sorba G, Genazzani AA, Gonzalez-Rodriguez S, Butron L, Devesa I, Fernandez-Carvajal A, Pirali T, Ferrer-Montiel A. Targeting Transient Receptor Potential Vanilloid 1 (TRPV1) Channel Softly: The Discovery of Passerini Adducts as a Topical Treatment for Inflammatory Skin Disorders. J Med Chem. 2018 May 24;61(10):4436-4455. doi: 10.1021/acs.jmedchem.8b00109. Epub 2018 May 15.
PubMed 29722529Marcotti A, Fernandez-Trillo J, Gonzalez A, Vizcaino-Escoto M, Ros-Arlanzon P, Romero L, Vela JM, Gomis A, Viana F, de la Pena E. TRPA1 modulation by Sigma-1 receptor prevents oxaliplatin-induced painful peripheral neuropathy. Brain. 2023 Feb 13;146(2):475-491. doi: 10.1093/brain/awac273.
PubMed 35871491Villalba-Riquelme E, de la Torre-Martinez R, Fernandez-Carvajal A, Ferrer-Montiel A. Paclitaxel in vitro reversibly sensitizes the excitability of IB4(-) and IB4(+) sensory neurons from male and female rats. Br J Pharmacol. 2022 Jul;179(14):3693-3710. doi: 10.1111/bph.15809. Epub 2022 Mar 7.
PubMed 35102580Starobova H, Vetter I. Pathophysiology of Chemotherapy-Induced Peripheral Neuropathy. Front Mol Neurosci. 2017 May 31;10:174. doi: 10.3389/fnmol.2017.00174. eCollection 2017.
PubMed 28620280Wang DS, Wang ZQ, Chen G, Peng JW, Wang W, Deng YH, Wang FH, Zhang JW, Liang HL, Feng F, Xie CB, Ren C, Jin Y, Shi SM, Fan WH, Lu ZH, Ding PR, Wang F, Xu RH, Li YH. Phase III randomized, placebo-controlled, double-blind study of monosialotetrahexosylganglioside for the prevention of oxaliplatin-induced peripheral neurotoxicity in stage II/III colorectal cancer. Cancer Med. 2020 Jan;9(1):151-159. doi: 10.1002/cam4.2693. Epub 2019 Nov 13.
PubMed 31724334Gewandter JS, Culakova E, Davis JN, Gada U, Guido JJ, Bearden JD, Burnette B, Shah D, Morrow GR, Mustian K, Sluka KA, Mohile N. Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Proof-of-Concept Randomized Clinical Trial. J Pain. 2024 May;25(5):104431. doi: 10.1016/j.jpain.2023.11.014. Epub 2023 Nov 21.
PubMed 37993030Accordino MK, Lee S, Leu CS, Levin B, Trivedi MS, Crew KD, Kalinsky K, Raghunathan R, Faheem K, Harden E, Taboada A, de Oliveira BD, Larson E, Franks L, Honan E, Law C, Hershman DL. Randomized adaptive selection trial of cryotherapy, compression therapy, and placebo to prevent taxane-induced peripheral neuropathy in patients with breast cancer. Breast Cancer Res Treat. 2024 Feb;204(1):49-59. doi: 10.1007/s10549-023-07172-y. Epub 2023 Dec 7.
PubMed 38060077Mezzanotte JN, Grimm M, Shinde NV, Nolan T, Worthen-Chaudhari L, Williams NO, Lustberg MB. Updates in the Treatment of Chemotherapy-Induced Peripheral Neuropathy. Curr Treat Options Oncol. 2022 Jan;23(1):29-42. doi: 10.1007/s11864-021-00926-0. Epub 2022 Feb 15.
PubMed 35167004Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14.
PubMed 24733808Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
PubMed 25261162Pachman DR, Qin R, Seisler DK, Smith EM, Beutler AS, Ta LE, Lafky JM, Wagner-Johnston ND, Ruddy KJ, Dakhil S, Staff NP, Grothey A, Loprinzi CL. Clinical Course of Oxaliplatin-Induced Neuropathy: Results From the Randomized Phase III Trial N08CB (Alliance). J Clin Oncol. 2015 Oct 20;33(30):3416-22. doi: 10.1200/JCO.2014.58.8533. Epub 2015 Aug 17.
PubMed 26282635
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Evaluation of the Degree of Skin Satisfaction of Cosmetics Creams PB-011 and PB-012 for Sensitive Skin in Oncological Patients Affected by a Palmoplantar Polyneuropathy Secondary to Chemotherapy or Chemotherapeutic Agents' Fusion to Monoclonal Antibodies (Immunocitostatics)
- ClinicalTrials.gov ID
- NCT06733545
- Acronym / sponsor ID
- 20-PB02
- Keywords
- CIPN, Sensitive skin, Quality of life, Chemotherapy, Chemotherapy skin side effects, palmoplantar discomfort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- PROSPERA BIOTECH S.L.Industry (pharma, biotech, devices)
- Collaborators
- Hospital General Universitario Elche, Hospital Miguel Servet, Hospital del Mar, Hospital Marina Baixa, Alicante, Hospital Universitario Ramon y Cajal, Hospital General Universitario Santa Lucia, Hospital Universitari Sagrat Cor, Barcelona, Hospital General de Elda, Centre Hospitalier Universitaire Saint Pierre, Universidad Miguel Hernandez de Elche
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 13 Dec 2024 (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.
It is proposed a controlled research study aimed to evaluating and comparing the degree of skin satisfaction and comfort with cosmetic creams PB-011 and PB-012 in cancer patients who can develop a palmar and plantar peripheral polyneuropathy by treatment with chemotherapy. Both products are cosmetic creams derived from the cosmetic Nocisens® line (for the care of sensitive skin with atopic tendency). The hypothesis that is proposed to test is that the care with PB-011 or PB-012 of the sensitive skin associated with palmar and plantar peripheral polyneuropathy of cancer patients will increase their degree of satisfaction and skin comfort. This study is proposed in patients who are going to start chemotherapeutic treatment. The study conceives two populations: (i) population where PB-011 cream will be tested; and (ii) population that will test PB-012 cream. A sample size of 60 volunteers per population has been estimated to ensure statistical significance. As a qualitative relevant variable for patients, the degree of satisfaction and skin comfort of the volunteers will be assessed by means of questionnaires.
Detailed description
This proof-of-concept clinical trial is a multicenter, double-blind, randomized, placebo-controlled research project approved by the ethics committees of all participating hospitals. Medical oncologists have been responsible for recruiting volunteers, checking that they meet the inclusion and exclusion criteria, obtaining signed informed consent, completing the data collection booklet and collecting the occurrence of CIPN and the degree of CIPN, along with patient follow-up. Once informed consent has been signed, the patients are provided with a PB-011 or the PB-012 formulation and started a daily application on their hands. After the onset of sensory symptoms on hands and/or feet, participants applied the cream twice daily on hands and feet and began responding questionnaires to evaluate the severity of sensorial symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PB-011 | – | –Patients starting chemotherapy treatment are given (double blinded) moisturizing cream PB-011 to use once a day in hands. If sensory discomfort appears in hands or feet, the dosage could be increased up to twice a day in hands and feet. |
| PB-012 | – | –Patients undergoing chemotherapy treatment are given (double blinded) moisturizing cream PB-012 to use once a day in hands. If sensory discomfort appears in hands or feet, the dosage could be increased up to twice a day in hands and feet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was anyone over 18 years of age who met the inclusion and exclusion criteria and who was about to start chemotherapy treatment.
Key inclusion criteria (8 listed)
- To be older than 18 year old
- To be able to complete questionnaires
- Give informed consent in writing
- Being able to apply the product under test by oneself
- To have been diagnosed with stage I-III primary cancer
Key exclusion criteria (13 listed)
- Not being or having been treated with antidepressants, antiepileptics or HIV medication in the last 3 months
- Pre-existing peripheral neuropathies not related to chemotherapy treatment
- Pre-existing neurodegenerative or neuromuscular disease or history of stroke
- Family history of neuropathic diseases
- Having suffered in the last 6 months: myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization or class III/IV heart failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory discomfort appearance in hands and/or feet as a measure of quality of life
Time frame: The estimated period of time over which the event is assessed is up to16 weeks, which correspond from the first CT cycle (cycles are received once a week, 12 CT cycles) up to one month later.
The appearance of sensory sensations resulting from CIPN will be detected by the oncologists' follow-up. The oncologists will indicate the treatment cycle in which the neuropathy discomfort appears and their degree in the data collection notebook. The study involves following the patient from the first cycle of chemotherapy until one month after the end of treatment.
1 secondary outcome
Skin Discomfort Severity
Time frame: Questionnaire was done every three weeks until one month after treatment was finished.
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 13 Dec 2024.
- Background: PubMed 34676514Bae EH, Greenwald MK, Schwartz AG. Chemotherapy-Induced Peripheral Neuropathy: Mechanisms and Therapeutic Avenues. Neurotherapeutics. 2021 Oct;18(4):2384-2396. doi: 10.1007/s13311-021-01142-2. Epub 2021 Oct 21.
- Background: PubMed 38660386Chen X, Gan Y, Au NPB, Ma CHE. Current understanding of the molecular mechanisms of chemotherapy-induced peripheral neuropathy. Front Mol Neurosci. 2024 Apr 10;17:1345811. doi: 10.3389/fnmol.2024.1345811. eCollection 2024.
- Background: PubMed 28580836Aromolaran KA, Goldstein PA. Ion channels and neuronal hyperexcitability in chemotherapy-induced peripheral neuropathy; cause and effect? Mol Pain. 2017 Jan-Dec;13:1744806917714693. doi: 10.1177/1744806917714693.
- Background: PubMed 33420359Nikolaeva-Koleva M, Butron L, Gonzalez-Rodriguez S, Devesa I, Valente P, Serafini M, Genazzani AA, Pirali T, Ballester GF, Fernandez-Carvajal A, Ferrer-Montiel A. A capsaicinoid-based soft drug, AG1529, for attenuating TRPV1-mediated histaminergic and inflammatory sensory neuron excitability. Sci Rep. 2021 Jan 8;11(1):246. doi: 10.1038/s41598-020-80725-z.
- Background: PubMed 29722529Serafini M, Griglio A, Aprile S, Seiti F, Travelli C, Pattarino F, Grosa G, Sorba G, Genazzani AA, Gonzalez-Rodriguez S, Butron L, Devesa I, Fernandez-Carvajal A, Pirali T, Ferrer-Montiel A. Targeting Transient Receptor Potential Vanilloid 1 (TRPV1) Channel Softly: The Discovery of Passerini Adducts as a Topical Treatment for Inflammatory Skin Disorders. J Med Chem. 2018 May 24;61(10):4436-4455. doi: 10.1021/acs.jmedchem.8b00109. Epub 2018 May 15.
- Background: PubMed 35871491Marcotti A, Fernandez-Trillo J, Gonzalez A, Vizcaino-Escoto M, Ros-Arlanzon P, Romero L, Vela JM, Gomis A, Viana F, de la Pena E. TRPA1 modulation by Sigma-1 receptor prevents oxaliplatin-induced painful peripheral neuropathy. Brain. 2023 Feb 13;146(2):475-491. doi: 10.1093/brain/awac273.
- Background: PubMed 35102580Villalba-Riquelme E, de la Torre-Martinez R, Fernandez-Carvajal A, Ferrer-Montiel A. Paclitaxel in vitro reversibly sensitizes the excitability of IB4(-) and IB4(+) sensory neurons from male and female rats. Br J Pharmacol. 2022 Jul;179(14):3693-3710. doi: 10.1111/bph.15809. Epub 2022 Mar 7.
- Background: PubMed 28620280Starobova H, Vetter I. Pathophysiology of Chemotherapy-Induced Peripheral Neuropathy. Front Mol Neurosci. 2017 May 31;10:174. doi: 10.3389/fnmol.2017.00174. eCollection 2017.
- Background: PubMed 31724334Wang DS, Wang ZQ, Chen G, Peng JW, Wang W, Deng YH, Wang FH, Zhang JW, Liang HL, Feng F, Xie CB, Ren C, Jin Y, Shi SM, Fan WH, Lu ZH, Ding PR, Wang F, Xu RH, Li YH. Phase III randomized, placebo-controlled, double-blind study of monosialotetrahexosylganglioside for the prevention of oxaliplatin-induced peripheral neurotoxicity in stage II/III colorectal cancer. Cancer Med. 2020 Jan;9(1):151-159. doi: 10.1002/cam4.2693. Epub 2019 Nov 13.
- Background: PubMed 37993030Gewandter JS, Culakova E, Davis JN, Gada U, Guido JJ, Bearden JD, Burnette B, Shah D, Morrow GR, Mustian K, Sluka KA, Mohile N. Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Proof-of-Concept Randomized Clinical Trial. J Pain. 2024 May;25(5):104431. doi: 10.1016/j.jpain.2023.11.014. Epub 2023 Nov 21.
- Background: PubMed 38060077Accordino MK, Lee S, Leu CS, Levin B, Trivedi MS, Crew KD, Kalinsky K, Raghunathan R, Faheem K, Harden E, Taboada A, de Oliveira BD, Larson E, Franks L, Honan E, Law C, Hershman DL. Randomized adaptive selection trial of cryotherapy, compression therapy, and placebo to prevent taxane-induced peripheral neuropathy in patients with breast cancer. Breast Cancer Res Treat. 2024 Feb;204(1):49-59. doi: 10.1007/s10549-023-07172-y. Epub 2023 Dec 7.
- Background: PubMed 35167004Mezzanotte JN, Grimm M, Shinde NV, Nolan T, Worthen-Chaudhari L, Williams NO, Lustberg MB. Updates in the Treatment of Chemotherapy-Induced Peripheral Neuropathy. Curr Treat Options Oncol. 2022 Jan;23(1):29-42. doi: 10.1007/s11864-021-00926-0. Epub 2022 Feb 15.
- Individual participant dataSharing planned: Yes. Data on the anonymised patients such as treatment, number of cycles, sex, age and morbidities during the study could be shared with reviwers or researchers.
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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.
Antonio Sonia Servitja, Oncologist principal investigator
Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)
Maria Castro-Henriques, Oncologist principal investigator
Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)
Iñaki Álvarez-Busto, Oncologist principal investigator
Servicio de Oncología Médica, Hospital Universitario Miguel Servet, 50009 Zaragoza (Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life (QOL) and CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by PROSPERA BIOTECH S.L. at 1 site in Spain.
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 8 inclusion and 13 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 13 Dec 2024. 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 Spain. 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?
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?
Sensory discomfort appearance in hands and/or feet as a measure of quality of life (time frame: The estimated period of time over which the event is assessed is up to16 weeks, which correspond from the first CT cycle (cycles are received once a week, 12 CT cycles) up to one month later.). 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 NCT06733545, which also lists 16 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 13 Dec 2024.