Neoplasm Related Pain (Acute) (Chronic)NCT01350583
Bicarbonate for Tumor Related Pain
A study testing Sodium Bicarbonate (NaHCO3) in people with Neoplasm Related Pain (Acute) (Chronic), 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 tolerated 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
- Conditions the study is for
- Neoplasm Related Pain (Acute) (Chronic)
- What is being tested?
- Sodium Bicarbonate (NaHCO3)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to May 2012
- Phase
- Interventional
- 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
- Patients must have metastatic or unresectable solid malignancy or hematologic malignancy (multiple myeloma or lymphoma) and must have moderate to severe tumor related pain (VAS>4) on a stable opioid regimen (at least 3 days of an opiate regimen).
- No planned palliative surgery, palliative radiotherapy for at least 2 weeks. However prior radiotherapy, and surgery is allowed and not limited to the number of procedures and courses. Concomitant chemotherapy is allowed. In addition, when it is anticipated that chemotherapy may result in rapid pain relief (less than 2 weeks), patients will only be enrolled after completing their first cycle of chemotherapy and provided their pain level is greater than 4 on the VAS.
- No evidence of neurologic or psychiatric compromise which in the opinion of the investigator will interfere with completion of study assessments
- Life expectancy greater than 3 months
- 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 4.
Who cannot join
- Patients with neuropathy and/or neuropathic pain as the only pain syndrome are not eligible. Patients with chronic non malignant pain are not eligible.
- Patients with renal insufficiency (creatinine > 2.5 mg/dL) are excluded
- Patients with history of congestive heart failure or pulmonary artery hypertension will be excluded
- Any patient who in the opinion of the investigator is dehydrated at the time of initial evaluation will be excluded.
- Patients with uncontrolled hypertension (systolic pressure >140, diastolic pressure >90) despite maximal antihypertensive therapy.
- Patients unable to ingest of oral sodium bicarbonate (such as patients with dysphagia or severe nausea)
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- Patients with ECOG performance status 4
- Patients with acute leukemia, myelodysplastic syndrome, and chronic myeloid leukemia are not eligible.
- Pregnant or lactating patients are not eligible.
- Patients with estimated survival less than 3 months
- 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 who are receiving and or will receive, during their participation in study, an oral chemotherapeutic agent whose bioavailability could be altered by the ingestion of sodium bicarbonate.
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 Pilot 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 tolerated sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn.
- Determine if sodium bicarbonate can reduce cancer-related pain. Right now, the investigators do not know for sure if these higher doses will be well tolerated or if they will reduce the pain associated with cancer. The investigators are doing this study to see if sodium bicarbonate is well tolerated and if it can reduce the requirements for pain medications.
Read the detailed description
The study is a single institution, non-randomized, single arm pilot study to evaluate the efficacy of adjuvant therapy with sodium bicarbonate for tumor related pain. Patients will receive sodium bicarbonate (0.15 g/kg/day for 1 weeks and if tolerated 0.3 g/kg/day for one week and if this dose is tolerated 0.6 g/kg/day) for 4 weeks. The sodium bicarbonate will be provided to the patient as a powder and consumed after it is mixed with about 250 cc (about 1 cup) of water. In consultation with the PI, the patients will be permitted to mix the sodium bicarbonate with a commercially available drink instead of water provided the liquid has an acid/base balance (pH) of 7.4 or greater. Patients with a good tolerance to study therapy and with at least a 30% improvement in pain intensity (by VAS) compared to baseline after 3 weeks of therapy and who wish to continue study therapy will be allowed to continue sodium bicarbonate therapy under the direction of their treating physician. Patients without at least a 30% improvement in pain intensity at 3 weeks will discontinue study therapy.
- Conditions
- Neoplasm Related Pain (Acute) (Chronic)
- Being tested
- Sodium Bicarbonate (NaHCO3)
- Keywords
- tumor related pain
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate (NaHCO3)Drug
Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Bicarbonate Therapy | Experimental | Dose Escalation Receives: Drug: Sodium Bicarbonate (NaHCO3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients With Improvement
Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.
Measured: 4 weeks per participant
Secondary outcomes (2)
Percent of Patients Where Treatment Was Well Tolerated
Tolerability and safety of oral sodium bicarbonate in patients with moderate to severe tumor related pain
Measured: 4 weeks per participant
Number of Participants With Improvement in Pain Indices
Improvement in pain indices (Memorial Symptom Assessment Scale, MSAS) and Brief Pain Inventory (BPI).
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 posted10 May 2011 (estimated)
- Study startAug 2010
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: PI Left Moffitt
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasm Related Pain (Acute) (Chronic)Studies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Gillies, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350583
- Sponsor's protocol ID
- MCC-16047
- Status last verified
- Jun 2013
- First submitted
- 6 May 2011
- Last updated
- 14 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
- ClinicalTrials.gov ID
- NCT01350583
- Acronym / sponsor ID
- MCC-16047
- Conditions
- Neoplasm Related Pain (Acute) (Chronic)
- Keywords
- tumor related pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Left Moffitt
- Enrolment
- 2 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Posted 8 Aug 2013
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 tolerated sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn.
- Determine if sodium bicarbonate can reduce cancer-related pain. Right now, the investigators do not know for sure if these higher doses will be well tolerated or if they will reduce the pain associated with cancer. The investigators are doing this study to see if sodium bicarbonate is well tolerated and if it can reduce the requirements for pain medications.
Detailed description
The study is a single institution, non-randomized, single arm pilot study to evaluate the efficacy of adjuvant therapy with sodium bicarbonate for tumor related pain. Patients will receive sodium bicarbonate (0.15 g/kg/day for 1 weeks and if tolerated 0.3 g/kg/day for one week and if this dose is tolerated 0.6 g/kg/day) for 4 weeks. The sodium bicarbonate will be provided to the patient as a powder and consumed after it is mixed with about 250 cc (about 1 cup) of water. In consultation with the PI, the patients will be permitted to mix the sodium bicarbonate with a commercially available drink instead of water provided the liquid has an acid/base balance (pH) of 7.4 or greater. Patients with a good tolerance to study therapy and with at least a 30% improvement in pain intensity (by VAS) compared to baseline after 3 weeks of therapy and who wish to continue study therapy will be allowed to continue sodium bicarbonate therapy under the direction of their treating physician. Patients without at least a 30% improvement in pain intensity at 3 weeks will discontinue study therapy.
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 Therapy | Experimental | Drug: Sodium Bicarbonate (NaHCO3)Dose Escalation |
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 (VAS>4) on a stable opioid regimen (at least 3 days of an opiate regimen).
- No planned palliative surgery, palliative radiotherapy for at least 2 weeks. However prior radiotherapy, and surgery is allowed and not limited to the number of procedures and courses. Concomitant chemotherapy is allowed. In addition, when it is anticipated that chemotherapy may result in rapid pain relief (less than 2 weeks), patients will only be enrolled after completing their first cycle of chemotherapy and provided their pain level is greater than 4 on the VAS.
- No evidence of neurologic or psychiatric compromise which in the opinion of the investigator will interfere with completion of study assessments
- Life expectancy greater than 3 months
- Age greater than 18 years and able to understand and sign the informed consent document
Key exclusion criteria (13 listed)
- Patients with neuropathy and/or neuropathic pain as the only pain syndrome are not eligible. Patients with chronic non malignant pain are not eligible.
- Patients with renal insufficiency (creatinine > 2.5 mg/dL) are excluded
- Patients with history of congestive heart failure or pulmonary artery hypertension will be excluded
- Any patient who in the opinion of the investigator is dehydrated at the time of initial evaluation will be excluded.
- Patients with uncontrolled hypertension (systolic pressure >140, diastolic pressure >90) 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 Bicarbonate (NaHCO3)Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated. | Drug | Sodium Bicarbonate Therapy |
Primary outcome
Percent of Patients With Improvement
Time frame: 4 weeks per participant
Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.
2 secondary outcomes
Percent of Patients Where Treatment Was Well Tolerated
Time frame: 4 weeks per participant
Number of Participants With Improvement in Pain Indices
Time frame: 4 weeks per participant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Robert Gillies, Ph.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 study testing Sodium Bicarbonate (NaHCO3) in people with Neoplasm Related Pain (Acute) (Chronic), 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 14 Aug 2013. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2013). 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?
Percent of Patients With Improvement (time frame: 4 weeks per participant). 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 NCT01350583, 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 14 Aug 2013.