Topic: Cancer
Conditions
Interventions
Folic Acid: Folic acid is a member of the B group of vitamins. It participates in cellular division, DNA synthesis and maturation of red blood cells. Patients randomised to the Folic Acid arm will tak
Study Entry : Single Randomisation only
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Experiencing =50 hot flushes per week, as quantified from daily patient Sloan Diary recordings for 7 days after consent and prior to randomisation 2. Being =40 and =70 years of age 3. Willing to participate in the trial and given informed consent; Target Gender: Female
Exclusion criteria
Exclusion criteria: As of 25/08/2016: 1. Baseline red cell serum folic acid level above the normal laboratory range (3.1 to 20.0µg/L) 2. Smoking >5 cigarettes per day 3. Intestinal malabsorption e.g. coeliac, tropical sprue or Crohn’s disease 4. Known chronic renal impairment or failure 5. Known established chronic conditions mimicking climacteric presentation e.g. poorly controlled hypertension, hyperglycaemia or thyroid instability 6. Pernicious anaemia due to vitamin B12 deficiency 7. Alcohol consumption more than 14 units per week 8. Women with phaeochromocytoma or other medullary tumours or carcinoid syndrome 9. Known allergic reactions and/or hypersensitivity to folic acid 10. Women who are, in the opinion of the treating physician, unlikely to be able to give informed consent or successfully complete the trial intervention and procedure 11.Participation in another clinical trial within the last 4 weeks prior to enrolment 12. Administration of the following drugs during study and for the specified number of weeks prior to study entry: 12.1. 24 weeks prior to randomisation: 12.1.1 Bevacizumab (Avastin) 12.1.2. Trastuzumab (Herceptin) 12.2. 8 weeks prior to randomisation: 12.2.1. HRT (women on oestrogen implants are excluded from trial entry) 12.2.2. Herbal remedies 12.2.3. Heparin 12.3. 6 weeks prior to randomisation: 12.3.1. Tamoxifen 12.3.2. Fluoxetine 12.3.3. Venlafaxine 12.4. 4 weeks prior to randomisation: 12.4.1. Phenytoin 12.4.2. Phenobarbitol 12.4.3. Primidone 12.5. 2 weeks prior to randomisation: 12.5.1. Warfarin 12.5.2. Sertraline 12.5.3. Mianserin 12.5.4. Mirtazapine 12.6. 1 week prior to randomisation: 12.6.1. Raloxifen 12.6.2. Chronic use of NSAIDs (including high dose Aspirin* and Cox-2 inhibitors) 12.6.3. Methotrexate 12.6.4. Fluorouracil 12.6.5. Trimethoprim 12.6.6. Co-trimoxazole 12.6.7. Chloramphenicol 12.6.8. Sulfasalazine 12.6.9. Paroxetine 12.6.10. Duloxetine 12.6.11. Clonidine *low dose Aspirin (75mg daily) is not prohibited 12.7. Stop prior to study entry: 12.8. Cholestyramine 12.9. Antacids (containing aluminium or magnesium) 12.10. Vitamin containing zinc or folic acid Initial 1. Hormonal or non hormonal treatment (including raloxifen) for menopausal symptoms within 8 weeks of enrolment 2. Baseline serum folic acid level which is above the normal laboratory range (3.1 to 20.0µg/L) 3. Smoking >5 cigarettes per day 4. Intestinal malabsorption e.g. celiac, tropical sprue or Crohn’s disease 5. Known chronic renal impairment or failure 6. Pernicious anaemia due to vitamin B12 deficiency 7. Taking the following drugs:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hot Flush Score; Timepoint(s): Change in Hot Flush Score at 12 weeks from randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in 5-HIAA levels and MHPG metabolites; Timepoint(s): In urine from randomisation at week 12 2. Change in frequency of hot flushes; Timepoint(s): Change from randomisation in frequency of hot flushes (mild,moderate and severe) at weeks 4, 8 and 12 3. Change in longitudinal QoL data; Timepoint(s): As measured by the Utian Quality of Life Scale at weeks 4, 8 and 12 4. Change in other menopausal symptoms; Timepoint(s): Using the Greene Climacteric Scale at weeks 4, 8 and 12 5. Change in whole blood levels of serotonin, plasma nor-adrenaline and serum folic acid; Timepoint(s): From randomisation at week 12 6. Correlation of blood changes with clinical improvement; Timepoint(s): Changes in whole blood levels of serotonin, nor-adrenaline, and serum folic acid at week 12 7. Effects in specific prognostic subgroups; Timepoint(s): Healthy women vs cancer survivors and BMI 30 8. Interim Change in Hot Flush Score; Timepoint(s): Change from randomisation in Hot Flush Score at weeks 4, 8 and 12 9. Percentage of responders; Timepoint(s): The percentage of responders at weeks 4, 8 and 12; defined as a reduction in Hot Flush Score of =50% | — |
Countries
England, United Kingdom
Outcome results
None listed