Folic acid supplementation in the management of menopausal symptoms in cancer survivors and healthy postmenopausal wome

Not Applicable

Completed

• Conditions: Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast; Cancer

• Registration Number: ISRCTN98158824
• Lead Sponsor: niversity of Birmingham

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33982872/ (added 18/11/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-11
• Study Completion: 2017-10-31
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 164

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

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:

Study & Design

• Study Type: Interventional
• Study Design: Not specified