Breast CancerPhase 3NCT02468739
Effect of GM1 in Prevention of Taxanes Induced Neurotoxicity in Operable Breast Cancer
A Phase 3 study testing Ganglioside-monosialic acid in people with Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Background: Taxane plays a key role in the treatment of breast cancer and taxane-induced peripheral neuropathy (TIPN) is a dose-limiting adverse effect leading to treatment discontinuation. Ganglioside-monosialic acid (GM1) functions as a neuroprotective factor. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ganglioside-monosialic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Dec 2016
- Phase
- Phase 3
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- There are any toxicity events of peripheral nervous system before enrollment, including: FACT-Ntx subscale score < 44;≥ Grade 1 peripheral toxicity according to CTCAE Version 4.0 rating scale;≥ Grade 1 peripheral toxicity according to ENS rating scale;All other pathological symptoms or diseases might affect the evaluation of adverse neurotoxic effects
- Patients having received other drug treatments might cause similar adverse neurotoxic effects within 4 weeks prior to the treatment of this protocol, or receive concurrent neurotoxic drugs. Including: Taxanes or analogues; Vinca alkaloids or analogues; Platinums or analogues; Cytarabine, thalidomide, bortezomib, or procarbazine; Other drugs or treatments might cause peripheral neurotoxicity
- Patients in poor general conditions, with KPS (Karnofsky performance status) scores < 80;
- Pregnant or lactating women；
- Patients (female) having the possibility of fertility but unwilling or not taking effective contraceptive measures
- Patients also having other neurological abnormalities who cannot accurately record the occurrence and severity of neurotoxicity;
Show all 12Show fewer
- Patients known allergy to trial drugs or excipient compositions of these products;
- Patients with inherited glucose and lipid metabolism abnormalities (gangliosidosis such as amaurotic family idiocy and retinopathy);
- Patients not suitable for treatment of ganglioside;
- Active infection (depending on the judgment of investigators);
- Patients with serious concurrent diseases might harmful to safety and interfere the scheduled treatment or concomitant diseases might affect the completion of the study, depending on the judgment of investigators.
- Patients with a history of definite neurological or dysphrenia, including epilepsy or dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Monosialotetrahexosyl Ganglioside (GM1) in Prevention of Taxanes Induced Neurotoxicity in Breast Cancer Patients Who Received Taxanes-based Adjuvant Chemotherapy: A Multi-center, Randomized, Placebo-controlled Trial
Background: Taxane plays a key role in the treatment of breast cancer and taxane-induced peripheral neuropathy (TIPN) is a dose-limiting adverse effect leading to treatment discontinuation. Ganglioside-monosialic acid (GM1) functions as a neuroprotective factor. However, the effects of GM1 on TIPN in breast cancer patients remains unknown.
Purpose: This randomized phase III trial is designed to evaluate the potential effects of GM1 for preventing TIPN in breast cancer patients.
Read the detailed description
Introduction： Taxanes is a key agent in the treatment of breast cancer. However, peripheral neuropathy markedly limits the use of taxanes. Unfortunately, current studies have neither revealed a clear mechanism nor established an effective treatment for Taxane-induced peripheral neuropathy (TIPN). Monosialotetrahexosyl ganglioside (GM1) functions as a neuroprotective factor. This multi-center, randomized, placebo-controlled trial was performed to assess the efficacy of GM1 fo preventing taxanes induced neurotoxicity in operable breast cancer patients who received taxanes-based adjuvant chemotherapy.
OBJECTIVES:
Primary Objective:
To evaluate the efficacy of gangliosides in the prevention of neurotoxicity in breast cancer patients treated with taxane-based chemotherapy. That is, to compare the differences in the scores of Functional Assessment of Cancer Treatment Neurotoxicity (FACT-Ntx) between the patients treated by GM1(the treatment group) and the placebo (the control group) at 2 weeks after completion of 4-cycles of taxane-based chemotherapy.
Secondary
- To compare the differences in the scores of Eastern Cooperative Oncology Group neuropathy scale between the patients treated by gangliosides (the experimental group) and the placebo (the control group);
- Tocompare the incidence of neurotoxic adverse events caused by taxane-based chemotherapy. That is, the difference between the patients of chemotherapy treated by gangliosides (the experimental group) and the placebo (the control group) in terms of the incidence of neurotoxicity (graded according to the NCI-CTCAE version 4.0 grading scale);
- Assess the safety and tolerance of the two treatment groups (ganglioside and placebo groups).
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients with early-stage breast cancer planning to receive taxane-based adjuvant chemotherapy were randomly assigned to receive GM1 (80 mg, Day -1 to Day 2) or placebo treatment.
Treatment group: Monosialotetrahexosylganglioside sodium is added into 250 mL of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy. At the same time, the patients are treated with a taxane-based chemotherapy selected by the investigators.
Placebo group: Placebo is added into 250 mL of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy. At the same time, the patients are treated with a taxane-based chemotherapy selected by the investigators.
The screening and baseline peripheral neurotoxicity assessment was performed 1 day before the start of the first course of taxane-containing chemotherapy.
The subjects will be treated by the study drugs according to the schedule until the completion of established taxane-based adjuvant chemotherapy, the onset of unacceptable toxicity, or when the patient withdraw from the study voluntarily.
Endpoint assessments including FACT-Ntx subscale, CTCAE version 4.0 grading scale and ENS subscales were performed at 2 weeks after each course of chemotherapy. Additional long-term assessments were performed at 3 months, 6 months and 1 year after the end of chemotherapy. The follow-up will be carried out until 2 years after the enrollment time of the last patient.
- Conditions
- Breast Cancer
- Being tested
- Ganglioside-monosialic acid, placebo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganglioside-monosialic acidDrug
Also called GM1
Ganglioside-monosialic sodium is added into to 250 ml of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy.(day -1, day 1 and day2). The dosages of GM1 are 80mg per day.
placeboDrug
Placebo is added into to 250 ml of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy.(day -1, day 1 and day2).
| Study group | Role | What they receive |
|---|---|---|
| Ganglioside-monosialic acid arm | Experimental | Patients will receive treatment of adjuvant chemotherapy. Ganglioside-monosialic acid(GM1, 80mg per day) will be given at 1 day before the start of chemotherapy for three days (Day -1, 1 and 2).
Chemotherapy regimens:
Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by paclitaxel (175 mg/m2 *4 cycles) after four courses of chemotherapy; Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by docetaxel (75 mg/m2 *4 cycles) after four course of chemotherapy; Docetaxel (75 mg/m2 q21d) combined with cyclophosphamide (600 mg/m2) for four courses.
The first day (D1) of each cycle is treated with taxane-based chemotherapy. 14-21 days are usually as one cycle. The methods of pretreatment and hydration shall be decided by the physicians. Receives: Drug: Ganglioside-monosialic acid |
| placebo arm | Placebo comparator | Patients will receive treatment of adjuvant chemotherapy. Placebo will be given at 1 day before the start of chemotherapy for three days (Day -1, 1 and 2).
Chemotherapy regimens:
Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by paclitaxel (175 mg/m2 *4 cycles) after four courses of chemotherapy; Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by docetaxel (75 mg/m2 *4 cycles) after four course of chemotherapy; Docetaxel (75 mg/m2 q21d) combined with cyclophosphamide (600 mg/m2) for four courses.
The first day (D1) of each cycle is treated with taxane-based chemotherapy. 14-21 days are usually as one cycle. The methods of pretreatment and hydration shall be decided by the physicians. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Functional Assessment of Cancer Treatment Neurotoxicity (FACT-Ntx) subscale between groups at 2 weeks after the 4-cycle chemotherapy
The primary endpoint was assessed using the Functional Assessment of Cancer Treatment, Gynecologic Oncology Group Neurotoxicity (FACT -Ntx) subscale at 2 weeks after completion of 4-cycles of taxane-based chemotherapy.
FACT-Ntx subscales contains 11 items including numbness, tingling, and discomfort in the hands or feet; difficulty hearing or tinnitus; joint pain or muscle cramps; weakness or fatigue; or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand; feeling pain or hard to breath when exposed to low temperature. Each Items is scored from 0 to 4 with a total score of 44; higher scores indicate better performance.
A 5-point difference in the FACT-Ntx subscale scores between groups is considered clinically meaningful.
The FACT-Ntx subscales assessments were performed at 2 weeks after each course of chemotherapy. Additional long-term assessments were performed at 3 months, 6 months and 1 year after the end of chemotherapy.
Measured: Day 1 of Week 1 to 1 year after the last course of chemotherapy
Secondary outcomes (2)
neurotoxicity evaluated by NCI-CTCAE version 4.0 grading scale
neurotoxicity evaluated by NCI-CTCAE version 4.0 grading scale which classified symptoms as grade 0, 1, 2, 3, or 4. Higher scores indicate more severe neurotoxicity.
The NCI-CTCAE version 4.0 assessments were performed at 2 weeks after each course of chemotherapy. Additional long-term assessments were performed at 3 months, 6 months and 1 year after the end of chemotherapy.
Measured: 1 monthDay 1 of Week 1 to 1 year after the last course of chemotherapy
neurotoxicity evaluated by the Eastern Cooperative Oncology Group neuropathy scale (ENS) subscales of sensory neuropathy, motor neurotoxicity, and neurogenic constipation.
The ENS subscales (from 0 to 4 scale) of sensory neuropathy, motor neurotoxicity, and neurogenic constipation were examined. For each of these scales, lower scores indicate better performance.
The ENS subscales assessments were performed at 2 weeks after each course of chemotherapy. Additional long-term assessments were performed at 3 months, 6 months and 1 year after the end of chemotherapy.
Measured: Day 1 of Week 1 to 1 year after the last course of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong-yu Yuan, Sun Yat-sen University
- Investigators
- Zhong-Yu Yuan, M.D., Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468739
- Sponsor's protocol ID
- SYSUCC-013
- Status last verified
- Nov 2021
- First submitted
- 14 May 2015
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Monosialotetrahexosyl Ganglioside (GM1) in Prevention of Taxanes Induced Neurotoxicity in Breast Cancer Patients Who Received Taxanes-based Adjuvant Chemotherapy: A Multi-center, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02468739
- Acronym / sponsor ID
- SYSUCC-013
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Taxane plays a key role in the treatment of breast cancer and taxane-induced peripheral neuropathy (TIPN) is a dose-limiting adverse effect leading to treatment discontinuation. Ganglioside-monosialic acid (GM1) functions as a neuroprotective factor. However, the effects of GM1 on TIPN in breast cancer patients remains unknown.
Purpose: This randomized phase III trial is designed to evaluate the potential effects of GM1 for preventing TIPN in breast cancer patients.
Detailed description
Introduction： Taxanes is a key agent in the treatment of breast cancer. However, peripheral neuropathy markedly limits the use of taxanes. Unfortunately, current studies have neither revealed a clear mechanism nor established an effective treatment for Taxane-induced peripheral neuropathy (TIPN). Monosialotetrahexosyl ganglioside (GM1) functions as a neuroprotective factor. This multi-center, randomized, placebo-controlled trial was performed to assess the efficacy of GM1 fo preventing taxanes induced neurotoxicity in operable breast cancer patients who received taxanes-based adjuvant chemotherapy.
OBJECTIVES:
Primary Objective:
To evaluate the efficacy of gangliosides in the prevention of neurotoxicity in breast cancer patients treated with taxane-based chemotherapy. That is, to compare the differences in the scores of Functional Assessment of Cancer Treatment Neurotoxicity (FACT-Ntx) between the patients treated by GM1(the treatment group) and the placebo (the control group) at 2 weeks after completion of 4-cycles of taxane-based chemotherapy.
Secondary
- To compare the differences in the scores of Eastern Cooperative Oncology Group neuropathy scale between the patients treated by gangliosides (the experimental group) and the placebo (the control group);
- Tocompare the incidence of neurotoxic adverse events caused by taxane-based chemotherapy. That is, the difference between the patients of chemotherapy treated by gangliosides (the experimental group) and the placebo (the control group) in terms of the incidence of neurotoxicity (graded according to the NCI-CTCAE version 4.0 grading scale);
- Assess the safety and tolerance of the two treatment groups (ganglioside and placebo groups).
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients with early-stage breast cancer planning to receive taxane-based adjuvant chemotherapy were randomly assigned to receive GM1 (80 mg, Day -1 to Day 2) or placebo treatment.
Treatment group: Monosialotetrahexosylganglioside sodium is added into 250 mL of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy. At the same time, the patients are treated with a taxane-based chemotherapy selected by the investigators.
Placebo group: Placebo is added into 250 mL of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy. At the same time, the patients are treated with a taxane-based chemotherapy selected by the investigators.
The screening and baseline peripheral neurotoxicity assessment was performed 1 day before the start of the first course of taxane-containing chemotherapy.
The subjects will be treated by the study drugs according to the schedule until the completion of established taxane-based adjuvant chemotherapy, the onset of unacceptable toxicity, or when the patient withdraw from the study voluntarily.
Endpoint assessments including FACT-Ntx subscale, CTCAE version 4.0 grading scale and ENS subscales were performed at 2 weeks after each course of chemotherapy. Additional long-term assessments were performed at 3 months, 6 months and 1 year after the end of chemotherapy. The follow-up will be carried out until 2 years after the enrollment time of the last patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ganglioside-monosialic acid arm | Experimental | Drug: Ganglioside-monosialic acidPatients will receive treatment of adjuvant chemotherapy. Ganglioside-monosialic acid(GM1, 80mg per day) will be given at 1 day before the start of chemotherapy for three days (Day -1, 1 and 2). Chemotherapy regimens: Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by paclitaxel (175 mg/m2 *4 cycles) after four courses of chemotherapy; Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by docetaxel (75 mg/m2 *4 cycles) after four course of chemotherapy; Docetaxel (75 mg/m2 q21d) combined with cyclophosphamide (600 mg/m2) for four courses. The first day (D1) of each cycle is treated with taxane-based chemotherapy. 14-21 days are usually as one cycle. The methods of pretreatment and hydration shall be decided by the physicians. |
| placebo arm | Placebo comparator | Drug: placeboPatients will receive treatment of adjuvant chemotherapy. Placebo will be given at 1 day before the start of chemotherapy for three days (Day -1, 1 and 2). Chemotherapy regimens: Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by paclitaxel (175 mg/m2 *4 cycles) after four courses of chemotherapy; Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by docetaxel (75 mg/m2 *4 cycles) after four course of chemotherapy; Docetaxel (75 mg/m2 q21d) combined with cyclophosphamide (600 mg/m2) for four courses. The first day (D1) of each cycle is treated with taxane-based chemotherapy. 14-21 days are usually as one cycle. The methods of pretreatment and hydration shall be decided by the physicians. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- There are any toxicity events of peripheral nervous system before enrollment, including: FACT-Ntx subscale score < 44;≥ Grade 1 peripheral toxicity according to CTCAE Version 4.0 rating scale;≥ Grade 1 peripheral toxicity according to ENS rating scale;All other pathological symptoms or diseases might affect the evaluation of adverse neurotoxic effects
- Patients having received other drug treatments might cause similar adverse neurotoxic effects within 4 weeks prior to the treatment of this protocol, or receive concurrent neurotoxic drugs. Including: Taxanes or analogues; Vinca alkaloids or analogues; Platinums or analogues; Cytarabine, thalidomide, bortezomib, or procarbazine; Other drugs or treatments might cause peripheral neurotoxicity
- Patients in poor general conditions, with KPS (Karnofsky performance status) scores < 80;
- Pregnant or lactating women；
- Patients (female) having the possibility of fertility but unwilling or not taking effective contraceptive measures
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 |
|---|---|---|
| Ganglioside-monosialic acidAlso: GM1Ganglioside-monosialic sodium is added into to 250 ml of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy.(day -1, day 1 and day2). The dosages of GM1 are 80mg per day. | Drug | Ganglioside-monosialic acid arm |
| placeboPlacebo is added into to 250 ml of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy.(day -1, day 1 and day2). | Drug | placebo arm |
Primary outcome
the Functional Assessment of Cancer Treatment Neurotoxicity (FACT-Ntx) subscale between groups at 2 weeks after the 4-cycle chemotherapy
Time frame: Day 1 of Week 1 to 1 year after the last course of chemotherapy
The primary endpoint was assessed using the Functional Assessment of Cancer Treatment, Gynecologic Oncology Group Neurotoxicity (FACT -Ntx) subscale at 2 weeks after completion of 4-cycles of taxane-based chemotherapy. FACT-Ntx subscales contains 11 items including numbness, tingling, and discomfort in the hands or feet; difficulty hearing or tinnitus; joint pain or muscle cramps; weakness or fatigue; or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand; feeling pain or hard to breath when exposed to low temperature. Each Items is scored from 0 to 4 with a total score of 44; higher scores indicate better performance. A 5-point difference in the FACT-Ntx subscale scores between groups is considered clinically meaningful. The FACT-Ntx subscales assessments were performed at 2 weeks after each course of chemotherapy. Additional long-term assessments were performed at 3 months, 6 months and 1 year after the end of chemotherapy.
2 secondary outcomes
neurotoxicity evaluated by NCI-CTCAE version 4.0 grading scale
Time frame: 1 monthDay 1 of Week 1 to 1 year after the last course of chemotherapy
neurotoxicity evaluated by the Eastern Cooperative Oncology Group neuropathy scale (ENS) subscales of sensory neuropathy, motor neurotoxicity, and neurogenic constipation.
Time frame: Day 1 of Week 1 to 1 year after the last course of chemotherapy
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 4 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Zhong-Yu Yuan, M.D. study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ganglioside-monosialic acid in people with Breast Cancer, run by Sun Yat-sen University at 1 site in China.
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 0 inclusion and 12 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 4 Nov 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 China. 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?
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?
the Functional Assessment of Cancer Treatment Neurotoxicity (FACT-Ntx) subscale between groups at 2 weeks after the 4-cycle chemotherapy (time frame: Day 1 of Week 1 to 1 year after the last course of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.