TumorPhase 1NCT01846429
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
A Phase 1 study testing Sodium Bicarbonate in people with Tumor and Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to: Determine how well people tolerate sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn. Determine if sodium bicarbonate can reduce cancer-related pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Sodium Bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to May 2015
- Phase
- 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
- Patients must have metastatic or unresectable solid malignancy or hematologic malignancy (multiple myeloma or lymphoma) and must have moderate to severe tumor related pain visual assessment scale (VAS)>4) on a stable or no opioid regimen (at least 3 days of an opiate regimen). VAS score should be greater than 4 at screening to be eligible.
- No planned palliative surgery, palliative radiotherapy for at least 4 weeks. However prior radiotherapy, and surgery is allowed and not limited to the number of procedures and courses. Concomitant chemotherapy with agents indicated in protocol guidelines (Tables 10 and 11B, Appendix IV) is allowed.
- No evidence of neurologic or psychiatric compromise which in the opinion of the investigator will interfere with completion of study assessments
- Age greater than 18 years and able to understand and sign the informed consent document
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status less than 3.
- A female patient and a male patient's female partner, of childbearing potential, must agree to use 2 adequate barrier methods of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting from Visit 1, while receiving protocol-specified medication, and for 1 month after stopping the medication.
Who cannot join
- Patients with neuropathy and/or neuropathic pain as the only pain syndrome are not eligible.
- Patients with only chronic non-malignant pain are not eligible.
- Patients with renal insufficiency (creatinine > 2.5mg/dL) are excluded.
- Patients with history of congestive heart failure or pulmonary artery hypertension will be excluded.
- Patients with uncontrolled hypertension (systolic pressure >160, diastolic pressure >100) despite maximal antihypertensive therapy
- Patients unable to ingest sodium bicarbonate capsules (such as patients with dysphagia or severe nausea)
Show all 13Show fewer
- Patients with ECOG performance status 3 or higher
- Patients with acute leukemia, myelodysplastic syndrome, and chronic myeloid leukemia are not eligible.
- Pregnant or lactating patients are not eligible.
- Patients with known allergy to sodium bicarbonate or patients with preexisting renal or acid base disorders for which sodium bicarbonate is contraindicated (such as metabolic alkalosis, severe congestive heart failure, hypernatremia, and hypocalcemia (see above))
- Patients with severe ongoing infections which places the patients at increased risks from therapy in the opinion of the investigator
- Patients receiving concomitant chemotherapy with agents indicated in protocol guidelines (Tables 10 and 11B, Appendix IV) or target therapy intended to prolong life within 2 weeks of starting the study drug
- Patients receiving experimental therapy within 2 weeks of starting study treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase I/II Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
The purpose of this study is to:
- Determine how well people tolerate sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn.
- Determine if sodium bicarbonate can reduce cancer-related pain.
Read the detailed description
Single institution Phase I/II study of sodium bicarbonate in combination with standard medical management for patients with moderate to severe tumor related pain.
Patients with metastatic solid malignancies and patients with hematologic malignancies with moderate to severe tumor related pain on a stable opioid regimen will be the subjects of this study.
- Conditions
- Tumor, Cancer, Pain, Malignant Solid Tumor, Unresectable Malignant Neoplasm, Hematologic Malignancy
- Being tested
- Sodium Bicarbonate
- Keywords
- cancer, pain fibers, acid levels, tumor related pain, cancer related pain, sodium bicarbonate, pain reliever, metastatic, unresectable, solid malignancy, hematologic malignancy, multiple myeloma, lymphoma
- Medical subject headings
- Neoplasms, Pain, Hematologic Neoplasms, Multiple Myeloma, Lymphoma, Neoplasm Metastasis, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium BicarbonateDrug
Cohort 1 patients will take 10 capsules/day; cohort 2 patients will take 20 capsules/day; cohort 3 patients will take 30 capsules/day and cohort 4 patients will take 40 capsules/day. Cohort 2 - 4 patients will begin at the cohort 1 dose and dose escalate to their respective cohort doses in order to prevent any side effects associated with alkalosis. Dose escalation will occur at a rate of 10 capsules/week.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Bicarbonate Treatment | Experimental | A 3+3 design for Phase I component and a two staged design for Phase II were to be used. Treatment: Sodium Bicarbonate Capsules (900 mg). Receives: Drug: Sodium Bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I - Maximum Tolerated Dose (MTD)
To evaluate the safety (Phase I) of oral Sodium bicarbonate capsules as an adjuvant pain reliever in patients with tumor related moderate to severe pain.
To determine the maximum tolerated dose (MTD) of oral sodium bicarbonate capsules for patients with tumor related moderate to severe pain.
Measured: 4 weeks per participant
Phase II - Percent of Participants With Desired Response
Evaluate the efficacy (Phase II) of oral Sodium Bicarbonate capsules as an adjuvant pain reliever in patients with tumor related moderate to severe pain.
Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale at 4 weeks compared to baseline without a corresponding increase in opioid regimen. The response rate with 95% Clopper-Pearson confidence interval will be reported.
Measured: 4 weeks per participant
Secondary outcomes (2)
Pain Measurement Ranking
Pain will be rated by the participant using a visual assessment scale (VAS) on a 0 to 10 scale. Mild Pain (1-4), Moderate Pain (5-6), Severe Pain (7-10). The change in pain between baseline and 4 weeks after treatment as measured by the VAS will be assessed using two-sided one-sample t-test or Wilcoxon signed-rank test, depending on whether normality assumption holds.
Measured: 4 weeks per participant
Quality of Life (QOL)
Quality of life will be assessed using the Memorial Symptom Assessment Scale (MSAS) and Brief Pain Inventory (BPI). The change in score between baseline and 4 weeks after treatment will be compared using two-sided one-sample t-test or Wilcoxon signed-rank test, as appropriate.
Measured: 4 weeks per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionMay 2015
Why it stopped: Drugs unavailable. Study did not progress to Phase 2.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Reliable Cancer Therapies
- Responsible party
- Sponsor
- Investigators
- Amit Mahipal, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846429
- Sponsor's protocol ID
- MCC-17136
- Status last verified
- Jun 2015
- First submitted
- 1 May 2013
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gillies RJ, Ibrahim-Hashim A, Ordway B, Gatenby RA. Back to basic: Trials and tribulations of alkalizing agents in cancer. Front Oncol. 2022 Nov 14;12:981718. doi: 10.3389/fonc.2022.981718. eCollection 2022.
PubMed 36452492
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
- ClinicalTrials.gov ID
- NCT01846429
- Acronym / sponsor ID
- MCC-17136
- Conditions
- Tumor, Cancer, Pain, Malignant Solid Tumor, Unresectable Malignant Neoplasm, Hematologic Malignancy
- Keywords
- cancer, pain fibers, acid levels, tumor related pain, cancer related pain, sodium bicarbonate, pain reliever, metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drugs unavailable. Study did not progress to Phase 2.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Reliable Cancer Therapies
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 May 2013 (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.
The purpose of this study is to:
- Determine how well people tolerate sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn.
- Determine if sodium bicarbonate can reduce cancer-related pain.
Detailed description
Single institution Phase I/II study of sodium bicarbonate in combination with standard medical management for patients with moderate to severe tumor related pain.
Patients with metastatic solid malignancies and patients with hematologic malignancies with moderate to severe tumor related pain on a stable opioid regimen will be the subjects of this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sodium Bicarbonate Treatment | Experimental | Drug: Sodium BicarbonateA 3+3 design for Phase I component and a two staged design for Phase II were to be used. Treatment: Sodium Bicarbonate Capsules (900 mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have metastatic or unresectable solid malignancy or hematologic malignancy (multiple myeloma or lymphoma) and must have moderate to severe tumor related pain visual assessment scale (VAS)>4) on a stable or no opioid regimen (at least 3 days of an opiate regimen). VAS score should be greater than 4 at screening to be eligible.
- No planned palliative surgery, palliative radiotherapy for at least 4 weeks. However prior radiotherapy, and surgery is allowed and not limited to the number of procedures and courses. Concomitant chemotherapy with agents indicated in protocol guidelines (Tables 10 and 11B, Appendix IV) is allowed.
- No evidence of neurologic or psychiatric compromise which in the opinion of the investigator will interfere with completion of study assessments
- Age greater than 18 years and able to understand and sign the informed consent document
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status less than 3.
Key exclusion criteria (13 listed)
- Patients with neuropathy and/or neuropathic pain as the only pain syndrome are not eligible.
- Patients with only chronic non-malignant pain are not eligible.
- Patients with renal insufficiency (creatinine > 2.5mg/dL) are excluded.
- Patients with history of congestive heart failure or pulmonary artery hypertension will be excluded.
- Patients with uncontrolled hypertension (systolic pressure >160, diastolic pressure >100) despite maximal antihypertensive therapy
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 |
|---|---|---|
| Sodium BicarbonateCohort 1 patients will take 10 capsules/day; cohort 2 patients will take 20 capsules/day; cohort 3 patients will take 30 capsules/day and cohort 4 patients will take 40 capsules/day. Cohort 2 - 4 patients will begin at the cohort 1 dose and dose escalate to their respective cohort doses in order to prevent any side effects associated with alkalosis. Dose escalation will occur at a rate of 10 capsules/week. | Drug | Sodium Bicarbonate Treatment |
Primary outcome
Phase I - Maximum Tolerated Dose (MTD)
Time frame: 4 weeks per participant
To evaluate the safety (Phase I) of oral Sodium bicarbonate capsules as an adjuvant pain reliever in patients with tumor related moderate to severe pain. To determine the maximum tolerated dose (MTD) of oral sodium bicarbonate capsules for patients with tumor related moderate to severe pain.
Phase II - Percent of Participants With Desired Response
Time frame: 4 weeks per participant
Evaluate the efficacy (Phase II) of oral Sodium Bicarbonate capsules as an adjuvant pain reliever in patients with tumor related moderate to severe pain. Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale at 4 weeks compared to baseline without a corresponding increase in opioid regimen. The response rate with 95% Clopper-Pearson confidence interval will be reported.
2 secondary outcomes
Pain Measurement Ranking
Time frame: 4 weeks per participant
Quality of Life (QOL)
Time frame: 4 weeks per participant
Results and safety
The study was stopped early (reason given: Drugs unavailable. Study did not progress to Phase 2.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Derived from this study: PubMed 36452492Gillies RJ, Ibrahim-Hashim A, Ordway B, Gatenby RA. Back to basic: Trials and tribulations of alkalizing agents in cancer. Front Oncol. 2022 Nov 14;12:981718. doi: 10.3389/fonc.2022.981718. eCollection 2022.
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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.
Amit Mahipal, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium Bicarbonate in people with Tumor and Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 6 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: stopped early, as of the sponsor's last update on 4 Jun 2015. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Drugs unavailable. Study did not progress to Phase 2.). Results are not available in the source record.
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?
Phase I - Maximum Tolerated Dose (MTD) (time frame: 4 weeks per participant). The study lists 2 primary outcomes in all. 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 NCT01846429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.