Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy

Mucositis Clinical Trial

— FASTERCC  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03581773
• Other study ID #: DARENCA 4
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2017
• Est. completion date: December 20, 2022

Study information

• Verified date: April 2020
• Source: University of Aarhus
• Contact: Frede Donskov, MD DMSc
• Phone: 004527147015
• Email: Frede.Donskov[@]auh.rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 24-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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Mucositis

Intervention

Drug:
• Folic Acid
5 mg pr day for 12 weeks
• Placebo Oral Tablet
1 placebo pill pr day for 12 weeks

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of oncology	Aarhus	Central Region Of Denmark
Denmark	Department of Oncology, Herlev Hospital	Herlev
Denmark	Department of Oncology, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Frede Donskov

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTCAE Mucositis	The degree of CTCAE mucositis (nasal, oral, pharyngeal, anal, or genital) according to the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE).	16 weeks
Secondary	PRO Mucositis frequency	The frequency of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC.	16 weeks
Secondary	Time to effect on mucositis	The median time to effect of study drug according to CTCAE 4.0 and PRO.	16 weeks
Secondary	Dose reductions	The frequency of TKI/mTOR dose reductions in the two groups	16 weeks
Secondary	Treatment discontinuations	The frequency of TKI/mTOR/immunotherapy treatment discontinuations in the two groups	16 weeks
Secondary	Treatment withdrawals	The frequency of TKI/mTOR/immunotherapy treatment withdrawals in the two groups	16 weeks
Secondary	GI adverse events degree	The degree of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.	16 weeks
Secondary	Hand-foot syndrome degree	The degree of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.	16 weeks
Secondary	QOL NCCN	The quality of life in the two groups according to NCCN-FACT FKSI-19.	16 weeks
Secondary	PRO Mucositis degree	The degree of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC.	16 weeks
Secondary	GI adverse events frequency	The frequency of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.	16 weeks
Secondary	Hand-foot syndrome frequency	The frequency of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.	16 weeks
Secondary	QOL MDASI	The quality of life in the two groups according the M.D. Anderson Symptom Inventory for RCC.	16 weeks