Clinical trial NCT03581773: Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy
Official title: FASTERCC: Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy. A Randomized, Double-blind Trial From the Danish Renal Cancer Group (DARENCA Study-4)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Mucositis
Stomatitis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled phase II trial of the effectiveness of folic acid supplement for 12 weeks on mucositis. Both arms will receive best supportive care. No crossover is allowed.
Primary purpose: TREATMENT

Brief summary: FASTERCC: Folic acid supplement versus placebo for treating mucositis adverse events in metastatic renal cell carcinoma patients receiving targeted therapy. A randomized, double-blind trial from the Danish renal cancer group (DARENCA study-4)

Detailed description: Mucositis (nasal, oral, pharyngeal, anal, or genital) is often experienced in relation to TKI, immunotherapy or mTOR inhibitor treatment in mRCC patients.

The present trial will assess whether 12 weeks complementary treatment with folic acid in mRCC-patients receiving TKI- or mTOR inhibitor treatment or immunotherapy and displaying CTCAE mucositis grade ≥2 can reduce the degree of mucositis, compared to PLACEBO.

This is a randomized, double-blind, placebo-controlled phase II trial of the effectiveness of folic acid supplement for 12 weeks on mucositis. Both arms will receive best supportive care. No crossover is allowed.

The investigators anticipate a 96-month accrual period. The power calculation indicates a total of 50 patients per group are required.

Block randomization based on received TKI/ mTOR inhibitor/IT-treatment will be performed.

Eligibility criteria: Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma.

Inclusion Criteria:

1. Patients displaying CTCAE ≥2 mucositis during TKI, mTOR inhibitor or immunotherapy 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%.

Exclusion Criteria:

1. Known hypersensitivity to folic acid.
2. Use of prednisolone more than 10 mg daily.

Primary outcomes:
measure: CTCAE Mucositis
timeFrame: 16 weeks
Secondary outcomes:
measure: PRO Mucositis frequency
timeFrame: 16 weeks
measure: Time to effect on mucositis
timeFrame: 16 weeks
measure: Dose reductions
timeFrame: 16 weeks
measure: Treatment discontinuations
timeFrame: 16 weeks
measure: Treatment withdrawals
timeFrame: 16 weeks
measure: GI adverse events degree
timeFrame: 16 weeks
measure: Hand-foot syndrome degree
timeFrame: 16 weeks
measure: QOL NCCN
timeFrame: 16 weeks
measure: PRO Mucositis degree
timeFrame: 16 weeks
measure: GI adverse events frequency
timeFrame: 16 weeks
measure: Hand-foot syndrome frequency
timeFrame: 16 weeks
measure: QOL MDASI
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of oncology
state: Central Region Of Denmark
city: Herlev
country: Denmark
facility: Department of Oncology, Herlev Hospital
Study officials:
References:
citation: Fristrup N, Donskov F. Folic Acid Reduces Mucositis in Metastatic Renal Cell Carcinoma Patients: A Retrospective Study. Clin Genitourin Cancer. 2019 Aug;17(4):254-259. doi: 10.1016/j.clgc.2019.03.023. Epub 2019 Apr 6.