Chemotherapy-Induced Peripheral NeuropathyEarly Phase 1NCT04135326
Transcranial Direct Current Stimulation in Reducing Pain in Cancer Patients With Chemotherapy Induced Peripheral Neuropathy
A Early Phase 1 study testing Quality-of-Life Assessment, Questionnaire Administration and Transcranial Direct Current Stimulation in people with Chemotherapy-Induced Peripheral Neuropathy and Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This early phase I trial studies how well transcranial direct current stimulation works in reducing pain in cancer patients with chemotherapy induced peripheral neuropathy. Transcranial direct current stimulation is used for patients with brain injuries such as strokes as well as for mental health issues such as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy, Malignant Neoplasm
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Transcranial Direct Current Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2019to 26 Oct 2020
- Phase
- Early Phase 1
- 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
- Age greater than or equal to 18 years.
- Able to give a Voluntary written consent.
- Cancer patients with chemotherapy induced peripheral neuropathy of at least 3 months duration..
- Pain and/or tingling of at least 4/10
Who cannot join
- History of seizure
- History of migraine headache
- History of brain cancer and/or brain metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) to Reduce Pain in Patients With Chemotherapy Induced Peripheral Neuropathy: A Pilot Study
This early phase I trial studies how well transcranial direct current stimulation works in reducing pain in cancer patients with chemotherapy induced peripheral neuropathy. Transcranial direct current stimulation is used for patients with brain injuries such as strokes as well as for mental health issues such as depression and may help to control pain in cancer patients with chemotherapy induced peripheral neuropathy.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of transcranial direct current stimulation (tDCS) in reducing chemotherapy induced painful peripheral neuropathy (CIPPN).
Ia. Evaluate the change in pain scores Ib. Assess for changes in other symptoms (i.e insomnia, feeling of well-being, depression and anxiety).
SECONDARY OBJECTIVES:
- To evaluate the following with the treatment of tDCS:
Ia. Assess for changes in using pain medications. Ib. Assess for changes in functioning (daily activities). Ic. Assess for changes in quality of life. Id. Assess for changes in neuropathy. Ie. Assess overall satisfaction with the tDCS treatment.
TERTIARY OBJECTIVES:
- To evaluate tDCS treatment related side-effects.
OUTLINE:
Patients undergo tDCS once daily (QD) over 20 minutes 5 days each week (Monday-Friday) for 3 weeks.
After completion of study treatment, patients are followed up weekly for 3 weeks and at 4-6 weeks.
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration, Transcranial Direct Current Stimulation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Transcranial Direct Current StimulationProcedure or surgery
Also called tDCS
Undergo tDCS
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (tDCS) | Experimental | Patients undergo tDCS QD over 20 minutes 5 days each week (Monday-Friday) for 3 weeks. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in chemotherapy induced peripheral neuropathy pain score
The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst).
Measured: Baseline up to final day of treatment (3 weeks)
Secondary outcomes (5)
Change in total opioid requirement (morphine equivalent daily dosage)
Will be summarized using descriptive statistics including mean, standard deviation, median, range, and CIs.
Measured: Baseline up to 4-6 weeks post-treatment
Change in cancer related symptoms
We will analyze each patient's Pain Management Center Follow-Up/ Progress Notes and Standardize questionnaire which includes the assessment of the aforementioned symptoms on a 11-point numeric rating scales (0=none to 10=worst).
Measured: Baseline up to 4-6 weeks post-treatment
Change in functioning of Daily Activities
We will analyze each patient's Pain Management Center Follow-Up/ Progress Notes and Standardize questionnaire which includes the assessment of the aforementioned symptoms on a 11-point numeric rating scales (0=none to 10=worst).
Measured: Baseline up to 4-6 weeks post-treatment
Change in quality of life questionnaire
We will analyze each patient's Pain Management Center Follow-Up/ Progress Notes and Standardize questionnaire which includes the assessment of the aforementioned symptoms on a 11-point numeric rating scales (0=none to 10=worst).
Measured: Baseline up to 4-6 weeks post-treatment
Incidence of adverse events
Frequency counts and percentages will be documented.
Measured: Up to 4-6 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start10 Oct 2019
- Primary completion26 Oct 2020
- Study completion26 Oct 2020
Why it stopped: Per PI termination request, no patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Salahadin Abdi, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135326
- Sponsor's protocol ID
- 2018-0541
- Other IDs
- NCI-2019-03834, 2018-0541
- Status last verified
- Nov 2020
- First submitted
- 10 Oct 2019
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) to Reduce Pain in Patients With Chemotherapy Induced Peripheral Neuropathy: A Pilot Study
- ClinicalTrials.gov ID
- NCT04135326
- Acronym / sponsor ID
- 2018-0541
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Per PI termination request, no patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 22 Oct 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 early phase I trial studies how well transcranial direct current stimulation works in reducing pain in cancer patients with chemotherapy induced peripheral neuropathy. Transcranial direct current stimulation is used for patients with brain injuries such as strokes as well as for mental health issues such as depression and may help to control pain in cancer patients with chemotherapy induced peripheral neuropathy.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of transcranial direct current stimulation (tDCS) in reducing chemotherapy induced painful peripheral neuropathy (CIPPN).
Ia. Evaluate the change in pain scores Ib. Assess for changes in other symptoms (i.e insomnia, feeling of well-being, depression and anxiety).
SECONDARY OBJECTIVES:
- To evaluate the following with the treatment of tDCS:
Ia. Assess for changes in using pain medications. Ib. Assess for changes in functioning (daily activities). Ic. Assess for changes in quality of life. Id. Assess for changes in neuropathy. Ie. Assess overall satisfaction with the tDCS treatment.
TERTIARY OBJECTIVES:
- To evaluate tDCS treatment related side-effects.
OUTLINE:
Patients undergo tDCS once daily (QD) over 20 minutes 5 days each week (Monday-Friday) for 3 weeks.
After completion of study treatment, patients are followed up weekly for 3 weeks and at 4-6 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (tDCS) | Experimental | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Transcranial Direct Current StimulationPatients undergo tDCS QD over 20 minutes 5 days each week (Monday-Friday) for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than or equal to 18 years.
- Able to give a Voluntary written consent.
- Cancer patients with chemotherapy induced peripheral neuropathy of at least 3 months duration..
- Pain and/or tingling of at least 4/10
Key exclusion criteria (3 listed)
- History of seizure
- History of migraine headache
- History of brain cancer and/or brain metastasis
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 |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (tDCS) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (tDCS) |
| Transcranial Direct Current StimulationAlso: tDCSUndergo tDCS | Procedure or surgery | Supportive care (tDCS) |
Primary outcome
Change in chemotherapy induced peripheral neuropathy pain score
Time frame: Baseline up to final day of treatment (3 weeks)
The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst).
5 secondary outcomes
Change in total opioid requirement (morphine equivalent daily dosage)
Time frame: Baseline up to 4-6 weeks post-treatment
Change in cancer related symptoms
Time frame: Baseline up to 4-6 weeks post-treatment
Change in functioning of Daily Activities
Time frame: Baseline up to 4-6 weeks post-treatment
Change in quality of life questionnaire
Time frame: Baseline up to 4-6 weeks post-treatment
Incidence of adverse events
Time frame: Up to 4-6 weeks post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
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The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
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RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
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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.
Salahadin Abdi principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Quality-of-Life Assessment, Questionnaire Administration and Transcranial Direct Current Stimulation in people with Chemotherapy-Induced Peripheral Neuropathy and Malignant Neoplasm, run by M.D. Anderson Cancer Center 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 4 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: withdrawn, as of the sponsor's last update on 9 Oct 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in chemotherapy induced peripheral neuropathy pain score (time frame: Baseline up to final day of treatment (3 weeks)). 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 9 Oct 2024.