Folic acid supplement versus placebo for treating side effects due to cancer treatment in metastatic renal cell carcinoma (FASTERCC). A Danish renal cancer group study (DARENCA-4).

Phase 1

• Conditions: Mucositis (nasal, oral, pharyngeal, anal, or genital) is often experienced in relation to TKI and mTOR inhibitor treatment of metastatic renal cell carcinoma patients. The present trial will assess whether a complementary treatment with folic acid in patients displaying mucositis =2 based on the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) can reduce the degree of mucositis, compared to PLACEBO.; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 21.1Level: LLTClassification code 10064282Term: Vaginal mucositisSystem Organ Class: 100000004872; MedDRA version: 20.0Level: LLTClassification code 10028130Term: Mucositis oralSystem Organ Class: 100000004856; MedDRA version: 20.0Level: LLTClassification code 10065721Term: Anal mucositisSystem Organ Class: 100000004856; MedDRA version: 20.0Level: LLTClassification code 10028127Term: MucositisSystem Organ Class: 100000004867; MedDRA version: 20.0Level: LLTClassification code 10065881Term: Pharyngeal mucositisSystem Organ Class: 100000004855

• Registration Number: EUCTR2016-001193-15-DK
• Lead Sponsor: Department of Oncology, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-18
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Patients displaying CTCAE =2 mucositis during TKI or mTOR inhibitor treatment.
2.Signed written informed consent obtained prior to any study specific procedures.
3.Patient must be willing and able to comply with the protocol.
4.Age > 18.
5.Biopsy proven locally advanced or metastatic renal cell carcinoma.
6.Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
7.Fertile women of childbearing potential (<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).
8.Karnofsky Performance status > 60%.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Known hypersensitivity to folic acid

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified