Preventive Effect of Diclofenac Topical for Capecitabine Related Hand-Foot Syndrome a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Preventive Effect of Diclofenac Topical for Capecitabine Related Hand-Foot Syndrome a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial - J-SUPPORT and Diclofenac cream reforms capecitabine therapy: J-DIRECT trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031240705

Enrollment

320

Registered

2025-02-26

Start date

2025-04-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal, gastric, and breast cancer

Interventions

Topical diclofenac sodium 0.1% cream or placebo are applied to the palms and sole daily in the morning and evening. More than one fingertip unit (1 fingertip unit provides 0.5 g) of study drugs are ap

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (i)Colorectal, breast, or gastric cancer patients undergoing treatment regimens containing capecitabine (>=800 mg/m2) (ii)ECOG performance status of 0 to 1 (iii)Age >= 18 years old (iv)Adequate organ function (v)Provision of written informed consent.

Exclusion criteria

Exclusion criteria: (i)Patients with aspirin induced asthma or a history of aspirin induced asthma (ii)A history of hypersensitivity to local diclofenac (iii)Having diseases that require the constant use of steroids or dermatitis that makes it difficult to evaluate the efficacy of the study drug (iv)Scheduled to receive celecoxib, pyridoxine, and steroids on an ongoing basis after initiation of chemotherapy (v)Having skin disease or residual chemotherapy-induced skin lesions on the palms or sole prior to the start of chemotherapy (vi)Pregnant or those who are unable to cooperate with contraception during the period of this study (vii)Having paresthesia in the fingers or feet

Design outcomes

Primary

Measure	Time frame
The incidence of grade >= 2 HFS within three months	—

Secondary

Measure	Time frame
(i)The time to onset of grade >= 2 HFS (ii)The time to onset of grade >= 1 HFS within three months (iii)The incidence of grade >= 1 HFS within three months (iv)Incidence of dose reduction, schedule delay, and discontinuation rate of capecitabine caused by any grade of HFS (v)Dose intensity of capecitabine and capecitabine included chemotherapy (vi)Incidence of grade >= 2 peripheral sensory neuropathy (vii)Incidence of grade >= 1 capecitabine related adverse events (nausea, vomiting, appetite loss, diarrhea, oral mucositis, pigmentation, abnormality of liver and renal function, and neutropenia)	—

Measure

Time frame

(i)The time to onset of grade >= 2 HFS (ii)The time to onset of grade >= 1 HFS within three months (iii)The incidence of grade >= 1 HFS within three months (iv)Incidence of dose reduction, schedule delay, and discontinuation rate of capecitabine caused by any grade of HFS (v)Dose intensity of capecitabine and capecitabine included chemotherapy (vi)Incidence of grade >= 2 peripheral sensory neuropathy (vii)Incidence of grade >= 1 capecitabine related adverse events (nausea, vomiting, appetite loss, diarrhea, oral mucositis, pigmentation, abnormality of liver and renal function, and neutropenia)

—

Contacts

Public ContactYohei Iimura

The IMSUT Hospital, The Institute of Medical Science, The University of Tokyo

youhei0519@g.ecc.u-tokyo.ac.jp+81-3-5449-5353

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026