Acute PainPhase 2NCT02297412
Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel
A Phase 2 study testing Minocycline Hydrochloride, Quality-of-Life Assessment and Questionnaire Administration in people with Acute Pain and Breast Carcinoma, run by Academic and Community Cancer Research United at 12 sites in United States.
Trial summary
This randomized pilot trial studies how well minocycline hydrochloride works in reducing chemotherapy-induced peripheral neuropathy and acute pain in patients with breast cancer undergoing treatment with paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Breast Carcinoma, Peripheral Neuropathy
- What is being tested?
- Minocycline Hydrochloride, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 12 sitesUnited States
- Study dates
- Nov 2014to 8 Jul 2016
- Phase
- Phase 2
- 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
- Ability to complete questionnaires by themselves or with assistance
- Planned paclitaxel at a dose of 80 mg/m2 IV given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors)
- Life expectancy > 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only (determined per clinician discretion)
Who cannot join
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause
- History of allergic or other adverse reactions to minocycline
Show all 10Show fewer
- Prior exposure to neurotoxic chemotherapy
- Diagnosis of fibromyalgia
- Current or planned use of methoxyflurane, oral contraceptives, isotretinoin, penicillin, or ergot alkaloids
- History of allergic or other adverse reactions to tetracycline
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057
Marshfield Clinic
Marshfield, Wisconsin, 54449
Illinois CancerCare-Community Cancer Center
Normal, Illinois, 61761
Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
PCR Oncology
Pismo Beach, California, 93449
Women and Infants Hospital
Providence, Rhode Island, 02905
Mayo Clinic
Rochester, Minnesota, 55905
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101
Carle Cancer Center
Urbana, Illinois, 61801
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103
About this study
Official title: Pilot Clinical Trial Evaluating the Utility of Minocycline as an Agent to Decrease Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Paclitaxel-Induced Acute Pain Syndrome (P-APS): A Randomized Placebo-Controlled, Double Blind Trial
This randomized pilot trial studies how well minocycline hydrochloride works in reducing chemotherapy-induced peripheral neuropathy and acute pain in patients with breast cancer undergoing treatment with paclitaxel. Drugs used in chemotherapy, such as paclitaxel, may cause damage to nerves that result in aches, pains, and tingling or numbness of fingers and toes. Minocycline hydrochloride may help lessen nerve damage from paclitaxel and improve the quality of life in breast cancer patients.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate whether minocycline hydrochloride (minocycline) can alleviate paclitaxel-induced peripheral neuropathy.
II. To estimate whether minocycline can alleviate paclitaxel acute pain syndrome (P-APS).
III. To examine the possible relative toxicities related to minocycline therapy in this study situation.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive minocycline hydrochloride orally (PO) twice daily (BID) on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of the study, patients are followed up every month for 6 months.
- Conditions
- Acute Pain, Breast Carcinoma, Peripheral Neuropathy
- Being tested
- Minocycline Hydrochloride, Placebo, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Acute Pain, Breast Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline HydrochlorideDrug
Also called Dynacin, Minocin, Minomax, Minomycin
Given PO
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (minocycline hydrochloride) | Experimental | Patients receive minocycline hydrochloride PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Minocycline Hydrochloride; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (placebo) | Placebo comparator | Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Receives: Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) Per Assessment (aAUCpa) of Average Pain (Item 3 on the Daily Post-Paclitaxel Questionnaire)
Average Area Under the Curve (AUC) per assessment (aAUCpa) of average pain (item 3 on the Daily Post-Paclitaxel Questionnaire; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") over 12 weeks. Scores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.
Measured: Up to 12 weeks
Area Under the Curve (AUC) of EORTC CIPN20 Sensory Neuropathy Subscale
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory Neuropathy Subscale. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to week-12 are averaged to yield the aAUCpa per patient per subcale.
Measured: Up to course 12
Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire)
Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire); "Over the past week, did you experience fatigue?") over 12 weeks. Scores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.
Measured: Baseline to up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion8 Jul 2016
- Study completion8 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academic and Community Cancer Research United
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles Loprinzi, Principal investigator, Academic and Community Cancer Research United
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297412
- Sponsor's protocol ID
- RU221408I
- Other IDs
- NCI-2016-01592, RU221408I, P30CA015083
- Status last verified
- Jan 2022
- First submitted
- 14 Nov 2014
- Last updated
- 31 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial Evaluating the Utility of Minocycline as an Agent to Decrease Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Paclitaxel-Induced Acute Pain Syndrome (P-APS): A Randomized Placebo-Controlled, Double Blind Trial
- ClinicalTrials.gov ID
- NCT02297412
- Acronym / sponsor ID
- RU221408I
- Conditions
- Acute Pain, Breast Carcinoma, Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Academic and Community Cancer Research UnitedUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2014
- Primary completion
- 8 Jul 2016 (actual)
- Study completion
- 8 Jul 2016 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Posted 7 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot trial studies how well minocycline hydrochloride works in reducing chemotherapy-induced peripheral neuropathy and acute pain in patients with breast cancer undergoing treatment with paclitaxel. Drugs used in chemotherapy, such as paclitaxel, may cause damage to nerves that result in aches, pains, and tingling or numbness of fingers and toes. Minocycline hydrochloride may help lessen nerve damage from paclitaxel and improve the quality of life in breast cancer patients.
Detailed description
PRIMARY OBJECTIVES:
- To estimate whether minocycline hydrochloride (minocycline) can alleviate paclitaxel-induced peripheral neuropathy.
II. To estimate whether minocycline can alleviate paclitaxel acute pain syndrome (P-APS).
III. To examine the possible relative toxicities related to minocycline therapy in this study situation.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive minocycline hydrochloride orally (PO) twice daily (BID) on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of the study, patients are followed up every month for 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (minocycline hydrochloride) | Experimental | Drug: Minocycline Hydrochloride, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive minocycline hydrochloride PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. |
| Arm II (placebo) | Placebo comparator | Other: Placebo, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to complete questionnaires by themselves or with assistance
- Planned paclitaxel at a dose of 80 mg/m2 IV given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors)
- Life expectancy > 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only (determined per clinician discretion)
Key exclusion criteria (10 listed)
- Any of the following:
- Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause
- History of allergic or other adverse reactions to minocycline
- Prior exposure to neurotoxic chemotherapy
- Diagnosis of fibromyalgia
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 |
|---|---|---|
| Minocycline HydrochlorideAlso: Dynacin, Minocin, Minomax, MinomycinGiven PO | Drug | Arm I (minocycline hydrochloride) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO | Other | Arm II (placebo) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (minocycline hydrochloride), Arm II (placebo) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (minocycline hydrochloride), Arm II (placebo) |
Primary outcome
Area Under the Curve (AUC) Per Assessment (aAUCpa) of Average Pain (Item 3 on the Daily Post-Paclitaxel Questionnaire)
Time frame: Up to 12 weeks
Average Area Under the Curve (AUC) per assessment (aAUCpa) of average pain (item 3 on the Daily Post-Paclitaxel Questionnaire; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") over 12 weeks. Scores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.
Area Under the Curve (AUC) of EORTC CIPN20 Sensory Neuropathy Subscale
Time frame: Up to course 12
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory Neuropathy Subscale. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to week-12 are averaged to yield the aAUCpa per patient per subcale.
Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire)
Time frame: Baseline to up to 12 weeks
Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire); "Over the past week, did you experience fatigue?") over 12 weeks. Scores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Charles Loprinzi principal investigator
Academic and Community Cancer Research United
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minocycline Hydrochloride, Quality-of-Life Assessment and Questionnaire Administration in people with Acute Pain and Breast Carcinoma, run by Academic and Community Cancer Research United at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 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 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 7 Nov 2018). 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?
Area Under the Curve (AUC) Per Assessment (aAUCpa) of Average Pain (Item 3 on the Daily Post-Paclitaxel Questionnaire) (time frame: Up to 12 weeks). The study lists 3 primary outcomes in all. 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 31 Jan 2022.