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TerminatedNCT01350583Updated Aug 14, 2013Results posted

Bicarbonate for Tumor Related Pain

An interventional study of Sodium Bicarbonate (NaHCO3) in Neoplasm Related Pain (Acute) (Chronic), sponsored by H. Lee Moffitt Cancer Center and Research Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-14.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Not applicable, Interventional, and Supportive care

Why this study was terminated
PI Left Moffitt
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Neoplasm Related Pain (Acute) (Chronic)

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Keywords

  • tumor related pain
03

In context

Cancer Pain

338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.

This study's enrollment of 2 is below the median of 60 across 254 interventional studies indexed under Cancer Pain.

Browse Cancer Pain studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Sodium Bicarbonate Therapy

    Dose Escalation

    Drug: Sodium Bicarbonate (NaHCO3)

Interventions

  • DrugSodium 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.

06

What researchers measure

Primary outcomes

  1. Percent of Patients With Improvement

    Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.

    Time frame: 4 weeks per participant

Secondary outcomes

  1. Percent of Patients Where Treatment Was Well Tolerated

    Tolerability and safety of oral sodium bicarbonate in patients with moderate to severe tumor related pain

    Time frame: 4 weeks per participant

  2. Number of Participants With Improvement in Pain Indices

    Improvement in pain indices (Memorial Symptom Assessment Scale, MSAS) and Brief Pain Inventory (BPI).

    Time frame: 4 weeks per participant

07

Results

Posted Aug 8, 2013
Limitations and caveats
This Pilot Supportive Care study ended prematurely due to slow accrual and the initiating principal investigator leaving the institution. The outcome measures were based on 25 evaluable participants and there were only 2 participants enrolled.

Participant flow

This study was open to enrollment at Moffitt Cancer Center from August, 2010 through July, 2011. Two participants were actually enrolled during 2010.

Participant flow — Overall Study
MilestoneSodium Bicarbonate Therapy
Started2
Completed2
Not completed0

Outcome measures

PrimaryPercent of Patients With Improvement

Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.

Time frame:
4 weeks per participant

No measurements were reported for this outcome.

SecondaryPercent of Patients Where Treatment Was Well Tolerated

Tolerability and safety of oral sodium bicarbonate in patients with moderate to severe tumor related pain

Time frame:
4 weeks per participant

No measurements were reported for this outcome.

SecondaryNumber of Participants With Improvement in Pain Indices

Improvement in pain indices (Memorial Symptom Assessment Scale, MSAS) and Brief Pain Inventory (BPI).

Time frame:
4 weeks per participant

No measurements were reported for this outcome.

Adverse events

Collected over 10 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sodium Bicarbonate Therapy—0/2 (0%)1/2 (50%)
Most frequent other events
Most frequent other events
EventSodium Bicarbonate Therapy
NauseaGastrointestinal disorders1/2
VomitingGastrointestinal disorders1/2
Edema: head and neckBlood and lymphatic system disorders1/2
Edema: limbBlood and lymphatic system disorders1/2
Pain - Head/headacheGeneral disorders1/2

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Sodium Bicarbonate Therapy
<=18 years0
Between 18 and 65 years1
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)Sodium Bicarbonate Therapy
Female2
Male0
Region of Enrollment
Region of Enrollment(participants)Sodium Bicarbonate Therapy
United States2
08

Study locations

1 site
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01350583
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Responsible party
Sponsor
First posted
May 10, 2011
Start date
Aug 2010
Primary completion
May 2012
Completion
May 2012
Results posted
Aug 8, 2013
Last update
Aug 14, 2013

Study contacts

Robert Gillies, Ph.D.
principal investigator · H. Lee Moffitt Cancer Center and Research Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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